Trial Outcomes & Findings for Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019 (NCT NCT01797965)

Last Updated: 2019-12-04

Results Overview

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1501 participants

Primary outcome timeframe

First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)

Results posted on

2019-12-04

Participant Flow

Participants were enrolled in the study at 226 investigative sites in 28 countries (United States, Canada, Western European countries, Australia, Israel, Eastern European countries, Argentina, Brazil, India, and Mexico) from 15 February 2013 to 24 September 2018.

Participants who completed studies: 205MS301 (NCT01064401), 205MS203 (NCT01051349), 205MS302 (NCT01462318) were eligible to enroll in this long-term extension study.

Participant milestones

Participant milestones
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
Overall Study STARTED	597	607	70	227
Overall Study COMPLETED	48	38	62	154
Overall Study NOT COMPLETED	549	569	8	73

Reasons for withdrawal

Reasons for withdrawal
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
Overall Study Adverse Event	104	129	4	21
Overall Study Lost to Follow-up	9	8	1	2
Overall Study Consent withdrawn	130	117	3	35
Overall Study Investigator decision	21	15	0	0
Overall Study Death	2	4	0	0
Overall Study Disease progression, defined by protocol	3	1	0	0
Overall Study Reason Not Specified	280	295	0	15

Baseline Characteristics

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	Total n=1500 Participants Total of all reporting groups
Age, Customized Adults (18-64 years)	597 Participants n=5 Participants	606 Participants n=7 Participants	70 Participants n=5 Participants	227 Participants n=4 Participants	1500 Participants n=21 Participants
Sex: Female, Male Female	394 Participants n=5 Participants	400 Participants n=7 Participants	42 Participants n=5 Participants	130 Participants n=4 Participants	966 Participants n=21 Participants
Sex: Female, Male Male	203 Participants n=5 Participants	206 Participants n=7 Participants	28 Participants n=5 Participants	97 Participants n=4 Participants	534 Participants n=21 Participants
Race/Ethnicity, Customized White	546 Participants n=5 Participants	559 Participants n=7 Participants	2 Participants n=5 Participants	223 Participants n=4 Participants	1330 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	25 Participants n=21 Participants
Race/Ethnicity, Customized Other	18 Participants n=5 Participants	14 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	33 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	17 Participants n=5 Participants	18 Participants n=7 Participants	64 Participants n=5 Participants	0 Participants n=4 Participants	99 Participants n=21 Participants

PRIMARY outcome

Timeframe: First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)

Population: Safety Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with AEs	541 Participants	560 Participants	172 Participants	53 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with SAEs	157 Participants	190 Participants	38 Participants	15 Participants

SECONDARY outcome

Timeframe: Up to 4.6 years in the 303 study

Population: Intent-to-treat (ITT) Population consisted of all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP during Study 303.

Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 205MS301, calculated using the negative binomial model.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period	0.158 relapses per year Interval 0.134 to 0.188	0.163 relapses per year Interval 0.138 to 0.193	0.080 relapses per year Interval 0.047 to 0.136	0.167 relapses per year Interval 0.097 to 0.288

SECONDARY outcome

Timeframe: Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303.

Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 301, calculated using the negative binomial model.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period 301-303 Combined Study Period	0.247 relapses per year Interval 0.22 to 0.279	0.175 relapses per year Interval 0.154 to 0.199	—	—
ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period 301 Treatment Period	0.317 relapses per year Interval 0.28 to 0.36	0.195 relapses per year Interval 0.169 to 0.225	—	—

SECONDARY outcome

Timeframe: Up to 4.6 years in the 303 study

Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Relapse in the 205MS303 Treatment Period	184 Participants	172 Participants	35 Participants	16 Participants

SECONDARY outcome

Timeframe: Up to 5.6 years combining 303 with the initial Study 301

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Relapse in the 205MS301-303 Combined Study Period	339 Participants	261 Participants	—	—

SECONDARY outcome

Timeframe: Up to 4.6 years in Study 303

Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.

Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period	95 Participants	97 Participants	8 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 5.6 years combining 303 with the initial Study 301

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period	144 Participants	130 Participants	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303

Population: 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies. Number analyzed is the number of participants with data available at the given timepoint.

T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 48	270 Participants	144 Participants	—	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 96	213 Participants	130 Participants	—	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 144	223 Participants	157 Participants	—	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 192	173 Participants	126 Participants	—	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 240	20 Participants	22 Participants	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 24, 96, 144 in Study 301

Population: 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint.

T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period Week 24	347 Participants	314 Participants	—	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period Week 96	435 Participants	368 Participants	—	—
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period Week 144	126 Participants	113 Participants	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96

Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.

Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period Baseline 303	180 Participants	77 Participants	—	—
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period Week 48	89 Participants	46 Participants	—	—
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period Week 96	43 Participants	23 Participants	8 Participants	2 Participants
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period Week 144	43 Participants	42 Participants	—	—
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period Week 192	25 Participants	29 Participants	—	—
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period Week 240	1 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 24, 96 and 144

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.

Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period Baseline 301	263 Participants	265 Participants	—	—
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period Week 24	153 Participants	119 Participants	—	—
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period Week 96	172 Participants	66 Participants	—	—
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period Week 144	49 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303

Population: 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies.

T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period Week 48	200 Participants	96 Participants	—	—
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period Week 96	168 Participants	91 Participants	—	—
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period Week 144	184 Participants	116 Participants	—	—
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period Week 192	152 Participants	94 Participants	—	—
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period Week 240	16 Participants	18 Participants	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 24, 96, 144 in Study 301

T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported .

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period Week 144	111 Participants	87 Participants	—	—
Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period Week 24	276 Participants	244 Participants	—	—
Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period Week 96	375 Participants	300 Participants	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303

To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Percent Change in Brain Volume From the 205MS303 Baseline Week 48	-0.451 percent change Standard Deviation 0.5917	-0.355 percent change Standard Deviation 0.5100	—	—
Percent Change in Brain Volume From the 205MS303 Baseline Week 96	-0.713 percent change Standard Deviation 0.7288	-0.549 percent change Standard Deviation 0.6126	—	—
Percent Change in Brain Volume From the 205MS303 Baseline Week 144	-1.050 percent change Standard Deviation 0.8566	-0.801 percent change Standard Deviation 0.7145	—	—
Percent Change in Brain Volume From the 205MS303 Baseline Week 192	-1.225 percent change Standard Deviation 1.0139	-0.967 percent change Standard Deviation 0.8772	—	—
Percent Change in Brain Volume From the 205MS303 Baseline Week 240	-1.261 percent change Standard Deviation 1.0382	-0.852 percent change Standard Deviation 0.9890	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303

To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Percent Change in Brain Volume From 205MS301 Baseline Week 48	-1.535 percent change Standard Deviation 1.1975	-1.409 percent change Standard Deviation 1.1538	—	—
Percent Change in Brain Volume From 205MS301 Baseline Week 96	-1.871 percent change Standard Deviation 1.3720	-1.595 percent change Standard Deviation 1.0736	—	—
Percent Change in Brain Volume From 205MS301 Baseline Week 144	-2.165 percent change Standard Deviation 1.4596	-1.812 percent change Standard Deviation 1.2044	—	—
Percent Change in Brain Volume From 205MS301 Baseline Week 192	-2.403 percent change Standard Deviation 1.6088	-1.970 percent change Standard Deviation 1.3439	—	—
Percent Change in Brain Volume From 205MS301 Baseline Week 240	-2.415 percent change Standard Deviation 1.6005	-1.922 percent change Standard Deviation 1.2258	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96

Population: ITT Population included all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP in Study 303. Number Analyzed is the number of participants with data available at the given timepoint.

Volume of T2 hyperintense Lesions was evaluated by MRI and was analyzed by a central MRI reader.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period Baseline 303	10357.54 millimeters cubed (mm^3) Standard Deviation 11977.864	9323.33 millimeters cubed (mm^3) Standard Deviation 10777.863	—	—
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 48	10738.32 millimeters cubed (mm^3) Standard Deviation 12358.857	9524.23 millimeters cubed (mm^3) Standard Deviation 10822.502	—	—
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 96	11498.94 millimeters cubed (mm^3) Standard Deviation 12769.813	10018.09 millimeters cubed (mm^3) Standard Deviation 11432.768	16116.01 millimeters cubed (mm^3) Standard Deviation 16791.388	12627.51 millimeters cubed (mm^3) Standard Deviation 14777.178
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 144	11242.79 millimeters cubed (mm^3) Standard Deviation 12838.060	10265.04 millimeters cubed (mm^3) Standard Deviation 11324.227	—	—
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 192	12453.96 millimeters cubed (mm^3) Standard Deviation 13643.373	10662.66 millimeters cubed (mm^3) Standard Deviation 11815.075	—	—
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period Week 240	9368.05 millimeters cubed (mm^3) Standard Deviation 12428.209	9230.78 millimeters cubed (mm^3) Standard Deviation 11395.493	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 12, 24 and 48 in Study 303

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies.

MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3"). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period Change to Week 24	-0.00599 z-score Interval -2.7855 to 1.6913	-0.00010 z-score Interval -3.4062 to 1.3673	—	—
Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period Change to Week 48	-0.01026 z-score Interval -3.722 to 1.7775	-0.01897 z-score Interval -3.5941 to 1.4111	—	—
Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period Baseline 303	0.24958 z-score Interval -5.5818 to 1.211	0.30019 z-score Interval -6.166 to 1.5643	—	—
Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period Change to Week 12	0.00010 z-score Interval -3.3934 to 1.6147	-0.01021 z-score Interval -4.5948 to 0.9577	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed: Number of participants with data available at given timepoint.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 36 for 301	0.04764 z-score Interval -3.0131 to 6.2565	0.05771 z-score Interval -11.0047 to 2.1389	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 48 for 301	0.06491 z-score Interval -1.6103 to 6.5816	0.07793 z-score Interval -1.3713 to 2.1024	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Baseline 301	0.14629 z-score Interval -6.4963 to 1.3731	0.14298 z-score Interval -2.9163 to 1.3865	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 12 for 301	-0.00133 z-score Interval -1.8674 to 6.4516	0.02593 z-score Interval -1.7953 to 2.3905	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 24 for 301	0.02377 z-score Interval -1.9966 to 6.2712	0.04728 z-score Interval -4.3661 to 2.1389	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 60 for 301	0.06893 z-score Interval -4.4756 to 6.6543	0.08973 z-score Interval -1.3564 to 1.9165	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 72 for 301	0.08645 z-score Interval -3.7849 to 6.7127	0.08690 z-score Interval -5.6579 to 2.0135	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 84 for 301	0.05704 z-score Interval -4.3418 to 6.694	0.10283 z-score Interval -5.4012 to 2.0493	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 96 for 301	0.06731 z-score Interval -4.1506 to 6.8296	0.11283 z-score Interval -5.8373 to 2.2536	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 108 for 301	0.08020 z-score Interval -4.8814 to 6.8182	0.09868 z-score Interval -5.0171 to 2.4199	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 120 for 301	0.08406 z-score Interval -4.4964 to 6.8441	0.10367 z-score Interval -3.4544 to 1.2502	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 132 for 301	0.07712 z-score Interval -4.6292 to 3.6137	0.08682 z-score Interval -3.9359 to 3.25	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 144 for 301	0.09674 z-score Interval -2.1875 to 4.0089	0.12943 z-score Interval -0.8767 to 1.2626	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 156 for 301	—	-0.0272 z-score Interval -0.0272 to -0.0272	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Baseline 303	0.06638 z-score Interval -1.9364 to 6.8441	0.11003 z-score Interval -5.0171 to 3.3811	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 12 for 303	0.06449 z-score Interval -2.8537 to 6.9351	0.09616 z-score Interval -5.3094 to 3.36	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 24 for 303	0.07140 z-score Interval -2.7241 to 6.787	0.12955 z-score Interval -5.0936 to 3.2141	—	—
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 48 for 303	0.05533 z-score Interval -2.8215 to 7.0425	0.09332 z-score Interval -5.3475 to 3.318	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303

Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.

The EDSS measures the disability status of people with multiple sclerosis as assessed by the Study Neurologist based on 8 functional systems that ranges from 0=normal neurologic exam; to 5=ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to 10=death due to MS. Higher scores indicate more disability. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 168	0.22 score on a scale Standard Deviation 0.798	0.19 score on a scale Standard Deviation 0.765	—	—
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 240	0.19 score on a scale Standard Deviation 0.789	0.26 score on a scale Standard Deviation 0.829	—	—
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 96	0.13 score on a scale Standard Deviation 0.729	0.13 score on a scale Standard Deviation 0.602	0.04 score on a scale Standard Deviation 0.400	0.01 score on a scale Standard Deviation 0.486
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 116	—	—	0.05 score on a scale Standard Deviation 0.353	0.11 score on a scale Standard Deviation 0.572
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 120	0.17 score on a scale Standard Deviation 0.768	0.11 score on a scale Standard Deviation 0.578	—	—
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 144	0.16 score on a scale Standard Deviation 0.742	0.17 score on a scale Standard Deviation 0.701	—	—
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Baseline 303	2.50 score on a scale Standard Deviation 1.468	2.44 score on a scale Standard Deviation 1.409	2.86 score on a scale Standard Deviation 1.500	2.56 score on a scale Standard Deviation 1.395
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 192	0.22 score on a scale Standard Deviation 0.756	0.22 score on a scale Standard Deviation 0.777	—	—
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 12	0.04 score on a scale Standard Deviation 0.464	0.02 score on a scale Standard Deviation 0.467	0.14 score on a scale Standard Deviation 0.244	0.00 score on a scale Standard Deviation 0.000
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 216	0.22 score on a scale Standard Deviation 0.775	0.22 score on a scale Standard Deviation 0.762	—	—
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 24	0.06 score on a scale Standard Deviation 0.570	0.03 score on a scale Standard Deviation 0.480	0.02 score on a scale Standard Deviation 0.237	-0.06 score on a scale Standard Deviation 0.325
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 48	0.09 score on a scale Standard Deviation 0.614	0.06 score on a scale Standard Deviation 0.495	0.00 score on a scale Standard Deviation 0.349	-0.05 score on a scale Standard Deviation 0.455
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 72	0.11 score on a scale Standard Deviation 0.670	0.10 score on a scale Standard Deviation 0.548	0.04 score on a scale Standard Deviation 0.378	0.00 score on a scale Standard Deviation 0.542
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period Change at Week 260	0.53 score on a scale Standard Deviation 1.007	-0.17 score on a scale Standard Deviation 0.718	—	—

SECONDARY outcome

Timeframe: Up to 4.6 years in Study 303

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies.

Participants without clinical or radiological activity are defined as disease-free. Clinical activity includes assessment of relapses and of disease progression. Radiological activity includes assessments of Gd+ lesions and new or enlarging T2 lesions.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period	9 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 12, 24, 48, 96, 120 and 144

Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.

The 29-item MSIS-29 is a disease specific participant-reported outcome measure that has been developed and validated to examine the physical (coordination and mobility) and psychological (mental) impact of MS from a participant's perspective; it measures 20 physical items and 9 psychological items. The results for each of the physical and psychological scores are transformed to a score of 0 to 100 (worse state of health). A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Physical Scores: Baseline 303	20.61 score on a scale Standard Deviation 20.134	19.19 score on a scale Standard Deviation 19.390	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Physical Scores: Change to Week 12	0.22 score on a scale Standard Deviation 11.114	-0.28 score on a scale Standard Deviation 9.217	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Physical Scores: Change to Week 24	-0.46 score on a scale Standard Deviation 10.313	-0.88 score on a scale Standard Deviation 9.147	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Physical Scores: Change to Week 48	0.12 score on a scale Standard Deviation 11.178	0.13 score on a scale Standard Deviation 9.779	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Physical Scores: Change to Week 96	2.23 score on a scale Standard Deviation 12.713	0.48 score on a scale Standard Deviation 10.617	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Physical Scores: Change to Week 120	0.51 score on a scale Standard Deviation 9.062	1.44 score on a scale Standard Deviation 10.504	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Physical Scores: Change to Week 144	-1.25 score on a scale Standard Deviation 0	-5.00 score on a scale Standard Deviation 0	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Psychological Scores: Baseline 303	23.46 score on a scale Standard Deviation 21.310	22.37 score on a scale Standard Deviation 20.816	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Psychological Scores: Change to Week 12	-1.06 score on a scale Standard Deviation 12.501	-0.34 score on a scale Standard Deviation 11.226	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Psychological Scores: Change to Week 24	-1.14 score on a scale Standard Deviation 14.154	-1.69 score on a scale Standard Deviation 11.576	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Psychological Scores: Change to Week 48	-0.46 score on a scale Standard Deviation 14.865	0.10 score on a scale Standard Deviation 13.648	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Psychological Scores: Change to Week 96	-0.16 score on a scale Standard Deviation 13.923	-0.89 score on a scale Standard Deviation 14.411	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Psychological Scores: Change to Week 120	-2.26 score on a scale Standard Deviation 10.105	0.00 score on a scale Standard Deviation 8.642	—	—
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period Psychological Scores: Change to Week 144	8.33 score on a scale Standard Deviation 0	-13.89 score on a scale Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303

The EQ-5D is a self-administered questionnaire consisting of 5 domains pertaining to specific health state profile : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participants recorded their level of current health for each domain where: 1=no problems, 2=some problem and 3=severe problems. The health score is derived from the individual scores for each of the 5 domains transformed to a score of 0=worst health state to 1=perfect health state. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Baseline 303	0.77 score on a scale Standard Deviation 0.233	0.79 score on a scale Standard Deviation 0.201	0.71 score on a scale Standard Deviation 0.242	0.77 score on a scale Standard Deviation 0.213
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 12	0.01 score on a scale Standard Deviation 0.168	-0.01 score on a scale Standard Deviation 0.137	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 24	0.01 score on a scale Standard Deviation 0.171	0.00 score on a scale Standard Deviation 0.144	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 48	-0.01 score on a scale Standard Deviation 0.185	-0.01 score on a scale Standard Deviation 0.152	0.00 score on a scale Standard Deviation 0.164	0.00 score on a scale Standard Deviation 0.174
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 96	0.00 score on a scale Standard Deviation 0.168	-0.02 score on a scale Standard Deviation 0.170	-0.01 score on a scale Standard Deviation 0.162	0.00 score on a scale Standard Deviation 0.184
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 120	0.01 score on a scale Standard Deviation 0.166	-0.01 score on a scale Standard Deviation 0.175	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 144	0.01 score on a scale Standard Deviation 0.187	-0.02 score on a scale Standard Deviation 0.172	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 192	0.00 score on a scale Standard Deviation 0.187	-0.03 score on a scale Standard Deviation 0.174	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period Change to Week 240	-0.01 score on a scale Standard Deviation 0.154	-0.06 score on a scale Standard Deviation 0.187	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303

The participant rated their current heath state using the EQ VAS 20-centimeter horizontal line from 0 (worst imaginable health state) to 100 (best imaginable health state). A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Baseline 303	76.19 score on a scale Standard Deviation 19.534	77.74 score on a scale Standard Deviation 19.144	72.13 score on a scale Standard Deviation 21.154	76.97 score on a scale Standard Deviation 19.225
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 12	1.42 score on a scale Standard Deviation 12.753	0.25 score on a scale Standard Deviation 12.358	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 24	1.20 score on a scale Standard Deviation 12.135	0.74 score on a scale Standard Deviation 11.400	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 48	0.66 score on a scale Standard Deviation 12.966	-0.35 score on a scale Standard Deviation 13.543	-1.50 score on a scale Standard Deviation 13.604	-0.64 score on a scale Standard Deviation 13.440
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 96	-0.54 score on a scale Standard Deviation 14.963	0.56 score on a scale Standard Deviation 12.054	0.45 score on a scale Standard Deviation 11.724	-0.95 score on a scale Standard Deviation 11.222
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 120	0.80 score on a scale Standard Deviation 13.406	1.52 score on a scale Standard Deviation 13.492	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 144	0.36 score on a scale Standard Deviation 14.263	1.64 score on a scale Standard Deviation 13.648	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 192	0.45 score on a scale Standard Deviation 15.058	0.66 score on a scale Standard Deviation 14.921	—	—
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period Change at Week 240	-0.64 score on a scale Standard Deviation 11.318	-1.53 score on a scale Standard Deviation 13.082	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303

Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period MS-related Site Visits: Baseline 303	141 site visits	102 site visits	27 site visits	11 site visits
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period MS-related Site Visits: Week 24	80 site visits	48 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period MS-related Site Visits: Week 48	100 site visits	70 site visits	15 site visits	6 site visits
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period MS-related Site Visits: Week 96	46 site visits	71 site visits	20 site visits	3 site visits
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period MS-related Site Visits: Week 144	37 site visits	36 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period MS-related Site Visits: Week 192	26 site visits	26 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period MS-related Site Visits: Week 240	6 site visits	16 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period Non-MS related Site Visits: Baseline 303	90 site visits	97 site visits	15 site visits	2 site visits
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period Non-MS related Site Visits: Week 24	81 site visits	56 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period Non-MS related Site Visits: Week 48	111 site visits	41 site visits	16 site visits	5 site visits
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period Non-MS related Site Visits: Week 96	90 site visits	93 site visits	23 site visits	10 site visits
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period Non-MS related Site Visits: Week 144	52 site visits	42 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period Non-MS related Site Visits: Week 192	42 site visits	39 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period Non-MS related Site Visits: Week 240	10 site visits	12 site visits	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301

Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period MS-related Site Visits: Week 120	55 site visits	18 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period MS-related Site Visits: Baseline 301	277 site visits	349 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period MS-related Site Visits: Week 24	76 site visits	78 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period MS-related Site Visits: Week 48	77 site visits	49 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period MS-related Site Visits: Week 72	60 site visits	49 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period MS-related Site Visits: Week 96	88 site visits	53 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period MS-related Site Visits: Week 144	13 site visits	24 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period Non MS-related Site Visits: Baseline 301	93 site visits	93 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period Non MS-related Site Visits: Week 24	50 site visits	45 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period Non MS-related Site Visits: Week 48	65 site visits	51 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period Non MS-related Site Visits: Week 72	54 site visits	69 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period Non MS-related Site Visits: Week 96	44 site visits	52 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period Non MS-related Site Visits: Week 120	43 site visits	41 site visits	—	—
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period Non MS-related Site Visits: Week 144	24 site visits	32 site visits	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303

Participants answered the question: "How satisfied or dissatisfied are you with the ability of the medication to prevent or treat the condition?" using the following scale: Dissatisfied (Extremely dissatisfied, Very dissatisfied, Dissatisfied) or Satisfied (Somewhat satisfied, Satisfied, Very Satisfied and Extremely satisfied). The number of participants in the Dissatisfied and Satisfied categories is reported.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Dissatisfied: Baseline 303	49 Participants	31 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Dissatisfied: Week 12	46 Participants	41 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Dissatisfied: Week 24	44 Participants	27 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Dissatisfied: Week 48	32 Participants	35 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Dissatisfied: Week 72	27 Participants	22 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Dissatisfied: Week 96	19 Participants	9 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Dissatisfied: Week 120	2 Participants	1 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Satisfied: Baseline 303	529 Participants	561 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Satisfied: Week 12	540 Participants	543 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Satisfied: Week 24	525 Participants	532 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Satisfied: Week 48	498 Participants	472 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Satisfied: Week 72	476 Participants	450 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Satisfied: Week 96	133 Participants	136 Participants	—	—
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period Satisfied: Week 120	25 Participants	23 Participants	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded their scheduled work hours. Data is reported by part time or full time employment.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Baseline 303	20.4 hours Standard Deviation 10.60	19.5 hours Standard Deviation 11.45	23.6 hours Standard Deviation 9.46	20.2 hours Standard Deviation 6.06
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 12	21.4 hours Standard Deviation 10.30	22.4 hours Standard Deviation 13.62	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 24	21.2 hours Standard Deviation 12.80	20.6 hours Standard Deviation 13.47	23.5 hours Standard Deviation 9.37	24.5 hours Standard Deviation 5.22
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 48	22.3 hours Standard Deviation 11.12	21.9 hours Standard Deviation 11.28	22.7 hours Standard Deviation 11.23	27.7 hours Standard Deviation 13.79
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 72	21.6 hours Standard Deviation 12.44	23.0 hours Standard Deviation 11.64	22.8 hours Standard Deviation 11.60	25.2 hours Standard Deviation 6.08
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 96	25.7 hours Standard Deviation 17.40	19.9 hours Standard Deviation 11.79	24.8 hours Standard Deviation 10.13	23.5 hours Standard Deviation 7.98
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 120	27.0 hours Standard Deviation 16.13	20.8 hours Standard Deviation 13.15	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 144	22.9 hours Standard Deviation 14.79	21.4 hours Standard Deviation 12.90	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 168	21.0 hours Standard Deviation 12.06	20.3 hours Standard Deviation 11.93	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 192	23.2 hours Standard Deviation 12.07	23.2 hours Standard Deviation 16.37	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 216	24.9 hours Standard Deviation 13.18	25.3 hours Standard Deviation 11.79	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Part Time: Week 240	21.3 hours Standard Deviation 8.54	—	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Baseline 303	36.8 hours Standard Deviation 14.23	37.4 hours Standard Deviation 12.71	39.3 hours Standard Deviation 12.23	40.1 hours Standard Deviation 10.44
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 12	37.3 hours Standard Deviation 14.23	38.5 hours Standard Deviation 18.79	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 24	35.0 hours Standard Deviation 15.43	36.4 hours Standard Deviation 17.43	37.2 hours Standard Deviation 14.19	42.0 hours Standard Deviation 7.34
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 48	36.0 hours Standard Deviation 13.47	38.2 hours Standard Deviation 20.63	38.6 hours Standard Deviation 10.90	41.1 hours Standard Deviation 8.50
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 72	36.9 hours Standard Deviation 12.90	38.5 hours Standard Deviation 12.21	38.4 hours Standard Deviation 9.91	42.0 hours Standard Deviation 5.24
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 96	36.0 hours Standard Deviation 13.42	37.6 hours Standard Deviation 12.35	36.4 hours Standard Deviation 14.36	41.5 hours Standard Deviation 5.05
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 120	37.7 hours Standard Deviation 11.04	39.2 hours Standard Deviation 22.80	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 144	37.3 hours Standard Deviation 12.79	39.7 hours Standard Deviation 12.68	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 168	37.3 hours Standard Deviation 12.35	39.4 hours Standard Deviation 10.36	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 192	37.7 hours Standard Deviation 10.31	40.4 hours Standard Deviation 9.00	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 216	37.7 hours Standard Deviation 12.44	38.8 hours Standard Deviation 11.68	—	—
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period Full Time: Week 240	39.8 hours Standard Deviation 4.16	39.3 hours Standard Deviation 12.33	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded whether their MS or its treatments caused them to miss work. Data is reported by part time or full time employment.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Baseline 303	11 Participants	7 Participants	1 Participants	1 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 12	10 Participants	8 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 24	12 Participants	7 Participants	3 Participants	2 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 48	9 Participants	7 Participants	2 Participants	1 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 72	7 Participants	4 Participants	2 Participants	2 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 96	6 Participants	5 Participants	2 Participants	2 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 120	11 Participants	6 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 144	4 Participants	6 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 168	5 Participants	6 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 192	5 Participants	3 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 216	1 Participants	4 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Part Time: Week 240	1 Participants	—	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Baseline 303	28 Participants	30 Participants	11 Participants	3 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 12	19 Participants	26 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 24	11 Participants	21 Participants	8 Participants	3 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 48	20 Participants	24 Participants	6 Participants	3 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 72	13 Participants	10 Participants	6 Participants	3 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 96	10 Participants	16 Participants	3 Participants	1 Participants
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 120	8 Participants	18 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 144	16 Participants	16 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 168	10 Participants	17 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 192	10 Participants	13 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 216	6 Participants	10 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period Full Time: Week 240	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded the hours they missed work due to MS or its treatments. Data is reported by part time or full time employment.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Baseline 303	8.5 hours Standard Deviation 5.82	5.6 hours Standard Deviation 4.93	12.0 hours Standard Deviation 0	20.0 hours Standard Deviation 0
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 12	8.7 hours Standard Deviation 8.43	8.4 hours Standard Deviation 8.11	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 24	15.2 hours Standard Deviation 19.31	10.1 hours Standard Deviation 3.63	8.3 hours Standard Deviation 6.51	3.0 hours Standard Deviation 1.41
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 48	8.6 hours Standard Deviation 4.85	12.3 hours Standard Deviation 12.83	4.5 hours Standard Deviation 3.54	15.0 hours Standard Deviation 0
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 72	7.5 hours Standard Deviation 7.01	10.1 hours Standard Deviation 13.05	16.0 hours Standard Deviation 19.80	7.0 hours Standard Deviation 4.24
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 96	22.2 hours Standard Deviation 38.48	8.7 hours Standard Deviation 12.02	5.0 hours Standard Deviation 0.00	22.5 hours Standard Deviation 3.54
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 120	9.5 hours Standard Deviation 5.92	7.3 hours Standard Deviation 8.21	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 144	3.3 hours Standard Deviation 2.22	10.3 hours Standard Deviation 7.18	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 168	7.3 hours Standard Deviation 7.90	5.3 hours Standard Deviation 5.16	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 192	3.6 hours Standard Deviation 1.14	9.0 hours Standard Deviation 4.24	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 216	3.0 hours Standard Deviation 0	16.4 hours Standard Deviation 15.71	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Part Time: Week 240	5.0 hours Standard Deviation 0	—	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Baseline 303	11.0 hours Standard Deviation 11.42	15.0 hours Standard Deviation 13.58	8.8 hours Standard Deviation 11.39	8.0 hours Standard Deviation 0.00
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 12	8.5 hours Standard Deviation 10.13	7.9 hours Standard Deviation 8.06	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 24	11.2 hours Standard Deviation 13.80	12.4 hours Standard Deviation 13.31	14.1 hours Standard Deviation 16.27	7.3 hours Standard Deviation 1.15
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 48	15.7 hours Standard Deviation 15.50	11.7 hours Standard Deviation 11.11	12.7 hours Standard Deviation 15.57	6.7 hours Standard Deviation 3.06
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 72	13.8 hours Standard Deviation 11.51	7.6 hours Standard Deviation 6.00	15.0 hours Standard Deviation 17.54	8.7 hours Standard Deviation 3.06
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 96	14.2 hours Standard Deviation 13.19	16.1 hours Standard Deviation 15.14	6.7 hours Standard Deviation 2.89	3.0 hours
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 120	12.4 hours Standard Deviation 13.88	10.7 hours Standard Deviation 11.19	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 144	16.0 hours Standard Deviation 14.32	13.1 hours Standard Deviation 15.44	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 168	7.3 hours Standard Deviation 4.45	16.9 hours Standard Deviation 15.73	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 192	15.9 hours Standard Deviation 11.94	10.0 hours Standard Deviation 11.53	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 216	10.3 hours Standard Deviation 13.98	11.2 hours Standard Deviation 14.00	—	—
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period Full Time: Week 240	—	14.5 hours Standard Deviation 4.95	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participants assessed the percent impact of MS and its treatments on their work output using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. Data is reported for part time or full time employment.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Baseline 303	18.4 percent impact Standard Deviation 24.18	21.1 percent impact Standard Deviation 26.16	19.0 percent impact Standard Deviation 24.78	32.2 percent impact Standard Deviation 34.65
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 12	18.8 percent impact Standard Deviation 24.06	16.0 percent impact Standard Deviation 22.87	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 24	17.5 percent impact Standard Deviation 24.30	16.8 percent impact Standard Deviation 22.84	26.5 percent impact Standard Deviation 33.85	14.4 percent impact Standard Deviation 14.42
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 48	16.0 percent impact Standard Deviation 23.54	14.0 percent impact Standard Deviation 23.03	18.8 percent impact Standard Deviation 25.03	19.1 percent impact Standard Deviation 24.17
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 72	20.8 percent impact Standard Deviation 27.63	18.8 percent impact Standard Deviation 27.93	23.3 percent impact Standard Deviation 29.50	11.1 percent impact Standard Deviation 10.83
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 96	18.4 percent impact Standard Deviation 24.01	16.8 percent impact Standard Deviation 23.90	19.1 percent impact Standard Deviation 23.80	22.3 percent impact Standard Deviation 33.41
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 120	19.6 percent impact Standard Deviation 26.58	22.4 percent impact Standard Deviation 30.15	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 144	17.4 percent impact Standard Deviation 23.16	15.3 percent impact Standard Deviation 24.07	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 168	35.7 percent impact Standard Deviation 33.82	15.3 percent impact Standard Deviation 22.93	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 192	30.9 percent impact Standard Deviation 33.29	21.4 percent impact Standard Deviation 25.03	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 216	23.6 percent impact Standard Deviation 27.73	20.3 percent impact Standard Deviation 28.78	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Part Time: Week 240	7.5 percent impact Standard Deviation 15.00	—	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Baseline 303	10.0 percent impact Standard Deviation 19.52	11.8 percent impact Standard Deviation 24.02	13.9 percent impact Standard Deviation 25.56	6.7 percent impact Standard Deviation 16.33
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 12	8.0 percent impact Standard Deviation 17.72	10.3 percent impact Standard Deviation 21.17	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 24	9.1 percent impact Standard Deviation 20.13	8.3 percent impact Standard Deviation 18.54	12.7 percent impact Standard Deviation 25.79	11.2 percent impact Standard Deviation 25.20
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 48	8.2 percent impact Standard Deviation 19.37	9.6 percent impact Standard Deviation 21.75	12.2 percent impact Standard Deviation 23.87	9.9 percent impact Standard Deviation 24.25
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 72	9.7 percent impact Standard Deviation 21.40	7.8 percent impact Standard Deviation 18.39	14.0 percent impact Standard Deviation 23.47	11.3 percent impact Standard Deviation 22.72
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 96	7.3 percent impact Standard Deviation 18.29	8.4 percent impact Standard Deviation 18.59	11.1 percent impact Standard Deviation 23.76	10.2 percent impact Standard Deviation 24.63
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 120	6.4 percent impact Standard Deviation 13.87	8.6 percent impact Standard Deviation 19.19	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 144	8.2 percent impact Standard Deviation 18.36	7.8 percent impact Standard Deviation 17.91	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 168	8.8 percent impact Standard Deviation 18.53	10.1 percent impact Standard Deviation 22.45	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 192	9.0 percent impact Standard Deviation 19.23	7.5 percent impact Standard Deviation 17.59	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 216	10.0 percent impact Standard Deviation 22.36	9.3 percent impact Standard Deviation 20.91	—	—
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period Full Time: Week 240	13.1 percent impact Standard Deviation 23.33	7.5 percent impact Standard Deviation 18.01	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded their planned hours for household chores.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Baseline 303	10.1 hours Standard Deviation 10.87	10.0 hours Standard Deviation 10.85	15.8 hours Standard Deviation 13.68	11.5 hours Standard Deviation 7.94
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 12	11.8 hours Standard Deviation 11.38	12.2 hours Standard Deviation 12.33	—	—
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 24	12.0 hours Standard Deviation 11.75	12.6 hours Standard Deviation 11.24	14.4 hours Standard Deviation 13.66	11.1 hours Standard Deviation 7.72
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 48	11.6 hours Standard Deviation 11.43	12.6 hours Standard Deviation 11.39	15.7 hours Standard Deviation 14.74	11.6 hours Standard Deviation 8.37
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 72	13.3 hours Standard Deviation 12.10	13.9 hours Standard Deviation 12.87	15.0 hours Standard Deviation 13.55	12.3 hours Standard Deviation 8.94
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 96	11.9 hours Standard Deviation 10.70	13.5 hours Standard Deviation 12.10	14.8 hours Standard Deviation 12.20	12.6 hours Standard Deviation 9.17
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 120	12.6 hours Standard Deviation 12.09	13.1 hours Standard Deviation 12.09	—	—
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 144	13.0 hours Standard Deviation 12.89	13.4 hours Standard Deviation 11.99	—	—
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 168	12.9 hours Standard Deviation 12.35	13.7 hours Standard Deviation 12.58	—	—
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 192	13.4 hours Standard Deviation 11.78	13.9 hours Standard Deviation 12.43	—	—
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 216	14.2 hours Standard Deviation 13.01	14.0 hours Standard Deviation 11.46	—	—
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period Week 240	13.6 hours Standard Deviation 11.49	10.1 hours Standard Deviation 7.89	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded whether MS or its treatments kept them from completing household chores.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Baseline 303	112 Participants	104 Participants	58 Participants	15 Participants
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 12	110 Participants	111 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 24	125 Participants	110 Participants	68 Participants	12 Participants
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 48	113 Participants	93 Participants	66 Participants	19 Participants
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 72	111 Participants	93 Participants	58 Participants	15 Participants
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 96	94 Participants	79 Participants	53 Participants	16 Participants
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 120	93 Participants	84 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 144	91 Participants	87 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 168	82 Participants	81 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 192	71 Participants	65 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 216	65 Participants	65 Participants	—	—
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period Week 240	2 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded the hours where they were not able to perform household chores due to MS or its treatments.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 192	6.9 hours Standard Deviation 9.01	5.7 hours Standard Deviation 5.96	—	—
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Baseline 303	6.4 hours Standard Deviation 7.82	5.1 hours Standard Deviation 5.08	5.4 hours Standard Deviation 6.25	5.2 hours Standard Deviation 4.06
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 12	7.0 hours Standard Deviation 9.35	5.9 hours Standard Deviation 7.63	—	—
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 24	6.3 hours Standard Deviation 7.56	5.2 hours Standard Deviation 4.59	5.7 hours Standard Deviation 7.75	5.0 hours Standard Deviation 3.57
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 48	7.3 hours Standard Deviation 11.41	4.7 hours Standard Deviation 3.53	7.9 hours Standard Deviation 9.19	4.7 hours Standard Deviation 4.21
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 72	7.2 hours Standard Deviation 7.16	6.6 hours Standard Deviation 10.32	6.8 hours Standard Deviation 8.03	5.8 hours Standard Deviation 4.46
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 96	5.2 hours Standard Deviation 3.93	5.1 hours Standard Deviation 4.67	8.1 hours Standard Deviation 9.35	3.8 hours Standard Deviation 3.81
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 120	6.0 hours Standard Deviation 8.23	5.9 hours Standard Deviation 11.13	—	—
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 144	5.7 hours Standard Deviation 4.95	6.3 hours Standard Deviation 6.10	—	—
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 168	5.8 hours Standard Deviation 5.19	5.5 hours Standard Deviation 5.16	—	—
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 216	6.9 hours Standard Deviation 7.09	7.3 hours Standard Deviation 10.97	—	—
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period Week 240	5.5 hours Standard Deviation 6.36	9.8 hours Standard Deviation 13.04	—	—

SECONDARY outcome

Timeframe: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303

The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant assessed the percent impact of MS and its treatments on how much they accomplished using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Baseline 303	16.0 percent impact Standard Deviation 23.16	17.5 percent impact Standard Deviation 25.31	25.3 percent impact Standard Deviation 29.42	18.9 percent impact Standard Deviation 24.41
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 12	16.7 percent impact Standard Deviation 24.40	17.5 percent impact Standard Deviation 25.38	—	—
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 24	17.0 percent impact Standard Deviation 25.23	16.7 percent impact Standard Deviation 24.71	25.5 percent impact Standard Deviation 28.81	24.8 percent impact Standard Deviation 30.25
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 48	16.9 percent impact Standard Deviation 25.48	17.1 percent impact Standard Deviation 26.23	23.8 percent impact Standard Deviation 28.52	21.0 percent impact Standard Deviation 27.62
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 72	19.9 percent impact Standard Deviation 26.83	17.8 percent impact Standard Deviation 26.13	25.4 percent impact Standard Deviation 27.88	19.6 percent impact Standard Deviation 23.37
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 96	16.4 percent impact Standard Deviation 25.39	17.7 percent impact Standard Deviation 26.18	23.8 percent impact Standard Deviation 29.07	21.4 percent impact Standard Deviation 27.23
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 120	17.4 percent impact Standard Deviation 25.10	16.9 percent impact Standard Deviation 25.00	—	—
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 144	16.5 percent impact Standard Deviation 24.40	17.4 percent impact Standard Deviation 25.25	—	—
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 168	19.1 percent impact Standard Deviation 26.03	18.2 percent impact Standard Deviation 26.37	—	—
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 192	18.5 percent impact Standard Deviation 26.55	17.3 percent impact Standard Deviation 25.07	—	—
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 216	18.8 percent impact Standard Deviation 26.11	18.3 percent impact Standard Deviation 26.18	—	—
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period Week 240	9.6 percent impact Standard Deviation 14.95	16.0 percent impact Standard Deviation 26.06	—	—

SECONDARY outcome

Timeframe: Up to 4.6 years in 303

Population: Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303.

Clinical Laboratory assessments included tests of hematology, blood chemistry, renal function, and thyroid function. The investigator determined if the results were clinically significant.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: After the first and fourth injections in 303, approximately Week 0 and Week 12

Population: Safety Population consisted of all participants who completed Study 301,203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received.

The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end: 0 =no pain on the left and 100=very painful on the right. The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=1500 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS First Injection, Post-dose	1.7 score on scale Standard Deviation 2.46	—	—	—
Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS Fourth Injection, Post-dose	1.6 score on scale Standard Deviation 2.34	—	—	—

SECONDARY outcome

Timeframe: After the first and fourth injections in 303, approximately Week 0 and Week 12

Population: Safety Population included all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received.

The investigator assessed the injection site after the first dose and before the fourth dose for the presence of erythema (None, Mild, Moderate, Severe), pigmentation (None, Hypo, Hyper), Induration (None, Mild, Moderate, Severe), Tenderness (None, Mild, Moderate, Severe) and Temperature (Normal, Warm, Hot). The number of participants in each grade is reported.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=1500 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Erythema: None	87 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Erythema: Mild	8 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Erythema: Moderate	2 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Erythema: Severe	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Erythema: None	87 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Erythema: Mild	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Erythema: Moderate	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Erythema: Severe	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Pigmentation: None	90 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Pigmentation: Hypo	7 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Pigmentation: Hyper	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Pigmentation: None	87 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Pigmentation: Hypo	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Pigmentation: Hyper	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Induration: None	89 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Induration: Mild	4 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Induration: Moderate	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Induration: Severe	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Induration: None	87 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Induration: Mild	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Induration: Moderate	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Induration: Severe	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Tenderness: None	94 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Tenderness: Mild	3 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Tenderness: Moderate	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose, Tenderness: Severe	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Tenderness: None	87 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Tenderness: Mild	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Tenderness: Moderate	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Tenderness: Severe	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose,Temperature: Normal	97 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose,Temperature: Warm	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories First Injection Post-dose,Temperature: Hot	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Temperature: Normal	87 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Temperature: Warm	0 Participants	—	—	—
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories Fourth Injection Pre-dose, Temperature: Hot	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 4.6 years in the 303 Treatment Period

Population: Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number of participants analyzed is the number of participants with evaluable data for this outcome measure.

Blood samples were collected for ADAbs and were analyzed using a laboratory test. The number of participants ADAb positive at any post-baseline timepoint is reported.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=603 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=68 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=35 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period	113 Participants	48 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 4.6 years in the 303 Treatment Period

Blood samples were collected for NAbs and were analyzed using a laboratory test. The number of participants NAb positive at any post-baseline timepoint is reported.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=67 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=35 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period	45 Participants	21 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline 303, Weeks 144, 168, 192, 240 in 303

Population: ITT Population: All participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data is collected for participants from 203 and 302 studies.

SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=408 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=400 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period Baseline 303	52.0 score on a scale Standard Deviation 15.13	52.4 score on a scale Standard Deviation 16.08	—	—
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period Change at Week 144	-3.0 score on a scale Standard Deviation 11.38	-3.5 score on a scale Standard Deviation 11.91	—	—
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period Change at Week 168	-1.9 score on a scale Standard Deviation 11.59	-3.7 score on a scale Standard Deviation 13.10	—	—
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period Change at Week 192	-2.5 score on a scale Standard Deviation 12.02	-2.8 score on a scale Standard Deviation 12.92	—	—
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period Change at Week 240	2.0 score on a scale Standard Deviation 10.78	-2.0 score on a scale Standard Deviation 15.38	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=577 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=584 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Baseline 301	47.8 score on a scale Standard Deviation 16.18	48.4 score on a scale Standard Deviation 16.32	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 24 for 301	1.3 score on a scale Standard Deviation 11.20	1.1 score on a scale Standard Deviation 12.42	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 48 for 301	2.7 score on a scale Standard Deviation 12.31	2.2 score on a scale Standard Deviation 12.01	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 72 for 301	3.0 score on a scale Standard Deviation 13.12	3.6 score on a scale Standard Deviation 12.98	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 96 for 301	3.0 score on a scale Standard Deviation 13.04	4.1 score on a scale Standard Deviation 13.09	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 120 for 301	3.5 score on a scale Standard Deviation 13.53	5.4 score on a scale Standard Deviation 12.75	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 144 for 301	3.2 score on a scale Standard Deviation 13.38	6.6 score on a scale Standard Deviation 13.15	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 144 for 303	0.7 score on a scale Standard Deviation 14.95	1.3 score on a scale Standard Deviation 13.92	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 168 for 303	2.0 score on a scale Standard Deviation 14.78	1.6 score on a scale Standard Deviation 14.86	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 192 for 303	1.7 score on a scale Standard Deviation 15.81	2.1 score on a scale Standard Deviation 15.35	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 216 for 303	4.7 score on a scale Standard Deviation 15.91	4.5 score on a scale Standard Deviation 14.59	—	—
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period Change from Baseline 301 at Week 240 for 303	3.8 score on a scale Standard Deviation 11.41	8.8 score on a scale Standard Deviation 9.42	—	—

SECONDARY outcome

Timeframe: Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303

The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Baseline 303	54.0 score on a scale Interval 0.0 to 60.0	54.0 score on a scale Interval 3.0 to 60.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 12	0.0 score on a scale Interval -40.0 to 19.0	0.0 score on a scale Interval -23.0 to 25.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 24	0.0 score on a scale Interval -26.0 to 26.0	0.0 score on a scale Interval -27.0 to 39.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 48	0.0 score on a scale Interval -41.0 to 21.0	0.0 score on a scale Interval -21.0 to 41.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 120	-3.0 score on a scale Interval -3.0 to -3.0	-1.0 score on a scale Interval -2.0 to 0.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 144	-1.0 score on a scale Interval -34.0 to 23.0	-1.0 score on a scale Interval -31.0 to 35.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 168	0.0 score on a scale Interval -35.0 to 21.0	0.0 score on a scale Interval -30.0 to 25.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 192	0.0 score on a scale Interval -33.0 to 26.0	0.0 score on a scale Interval -42.0 to 40.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 216	0.0 score on a scale Interval -22.0 to 16.0	0.0 score on a scale Interval -23.0 to 39.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period Change to Week 240	0.0 score on a scale Interval -8.0 to 12.0	-2.0 score on a scale Interval -9.0 to 6.0	—	—

SECONDARY outcome

Timeframe: Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study

Population: 301-303 ITT Population consisted of all participants who completed study 301 and had at least 1 dose of DAC HYP during study 303. Number analyzed is the number of participants with data available at the given timepoint.

Outcome measures

Outcome measures
Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 Participants DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 Participants Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Baseline 301	50.0 score on a scale Interval 0.0 to 60.0	51.0 score on a scale Interval 9.0 to 60.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 12 for 301	0.0 score on a scale Interval -58.0 to 40.0	1.0 score on a scale Interval -59.0 to 25.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 24 for 301	0.5 score on a scale Interval -26.0 to 31.0	1.0 score on a scale Interval -32.0 to 22.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 36 for 301	1.0 score on a scale Interval -29.0 to 30.0	1.0 score on a scale Interval -37.0 to 28.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 48 for 301	1.0 score on a scale Interval -25.0 to 42.0	1.0 score on a scale Interval -38.0 to 30.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 60 for 301	1.0 score on a scale Interval -46.0 to 40.0	2.0 score on a scale Interval -34.0 to 37.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 72 for 301	2.0 score on a scale Interval -20.0 to 40.0	2.0 score on a scale Interval -21.0 to 41.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 84 for 301	2.0 score on a scale Interval -31.0 to 39.0	2.0 score on a scale Interval -41.0 to 29.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 96 for 301	2.0 score on a scale Interval -28.0 to 41.0	2.0 score on a scale Interval -25.0 to 38.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 108 for 301	1.0 score on a scale Interval -27.0 to 43.0	2.0 score on a scale Interval -25.0 to 40.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 120 for 301	2.0 score on a scale Interval -27.0 to 35.0	2.0 score on a scale Interval -31.0 to 41.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 132 for 301	2.0 score on a scale Interval -30.0 to 35.0	2.0 score on a scale Interval -19.0 to 38.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 144 for 301	2.0 score on a scale Interval -25.0 to 31.0	3.0 score on a scale Interval -21.0 to 31.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 156 for 301	—	-4.0 score on a scale Interval -4.0 to -4.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Baseline 303	2.0 score on a scale Interval -34.0 to 44.0	2.0 score on a scale Interval -41.0 to 45.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 12 for 303	2.0 score on a scale Interval -38.0 to 43.0	2.0 score on a scale Interval -26.0 to 41.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 24 for 303	2.0 score on a scale Interval -31.0 to 40.0	2.0 score on a scale Interval -27.0 to 43.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 48 for 303	2.0 score on a scale Interval -47.0 to 44.0	2.0 score on a scale Interval -24.0 to 41.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 120 for 303	15.0 score on a scale Interval 15.0 to 15.0	3.0 score on a scale Interval 1.0 to 5.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 144 for 303	1.0 score on a scale Interval -32.0 to 37.0	2.0 score on a scale Interval -24.0 to 38.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 168 for 303	2.0 score on a scale Interval -36.0 to 42.0	2.0 score on a scale Interval -29.0 to 42.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 192 for 303	2.0 score on a scale Interval -40.0 to 42.0	2.0 score on a scale Interval -21.0 to 42.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 216 for 303	2.0 score on a scale Interval -27.0 to 40.0	2.0 score on a scale Interval -30.0 to 41.0	—	—
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period Change from Baseline 301 to Week 240 for 303	1.5 score on a scale Interval -10.0 to 26.0	0.5 score on a scale Interval -11.0 to 23.0	—	—

Adverse Events

IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)

Serious events: 157 serious events

Other events: 463 other events

Deaths: 2 deaths

DAC HYP 150 mg (301) /DAC HYP 150 mg (303)

Serious events: 190 serious events

Other events: 476 other events

Deaths: 4 deaths

DAC HYP 150 mg (302) /DAC HYP 150 mg (303)

Serious events: 15 serious events

Other events: 42 other events

Deaths: 0 deaths

DAC HYP 150 mg (203) /DAC HYP 150 mg (303)

Serious events: 38 serious events

Other events: 116 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Biogen Study Medical Director

Biogen

Phone: 866-633-4636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) n=597 participants at risk DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received IFN β-1a 30 µg IM injection once weekly in study 301 every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (301) /DAC HYP 150 mg (303) n=606 participants at risk Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.	DAC HYP 150 mg (302) /DAC HYP 150 mg (303) n=70 participants at risk DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years.	DAC HYP 150 mg (203) /DAC HYP 150 mg (303) n=227 participants at risk DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
Blood and lymphatic system disorders Lymphadenopathy	7.9% 47/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	11.7% 71/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	3.1% 7/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Gastrointestinal disorders Diarrhoea	7.0% 42/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.8% 35/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.9% 2/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.4% 10/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Gastrointestinal disorders Toothache	2.8% 17/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.3% 14/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.7% 4/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.3% 3/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
General disorders Fatigue	6.7% 40/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	6.8% 41/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.8% 4/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
General disorders Pyrexia	7.5% 45/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.1% 43/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	3.1% 7/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Bronchitis	4.9% 29/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.9% 36/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	0.44% 1/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Influenza	7.7% 46/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.8% 35/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.4% 1/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.8% 4/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Nasopharyngitis	20.3% 121/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	20.6% 125/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	8.6% 6/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.9% 18/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Oral herpes	7.0% 42/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.8% 35/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.6% 6/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Pharyngitis	8.9% 53/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.8% 47/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.4% 1/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.0% 9/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Sinusitis	6.9% 41/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 26/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.4% 1/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.8% 4/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Tonsillitis	5.7% 34/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.3% 14/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.7% 4/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	0.88% 2/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Upper respiratory tract infection	19.4% 116/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	18.8% 114/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	18.6% 13/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	11.5% 26/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Infections and infestations Urinary tract infection	12.9% 77/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	9.6% 58/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.7% 4/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.4% 10/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Investigations Alanine aminotransferase increased	7.5% 45/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.9% 48/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.0% 16/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Investigations Aspartate aminotransferase increased	6.7% 40/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.9% 48/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.9% 2/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.8% 11/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Investigations Liver function test abnormal	5.4% 32/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.0% 30/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.9% 2/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.6% 6/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 45/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	6.3% 38/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	3.1% 7/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Musculoskeletal and connective tissue disorders Back pain	10.9% 65/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	8.4% 51/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.3% 3/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.4% 10/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 34/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	6.6% 40/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.9% 2/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	0.88% 2/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Nervous system disorders Headache	9.5% 57/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	9.2% 56/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	10.0% 7/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.0% 16/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Nervous system disorders Multiple sclerosis relapse	30.0% 179/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	27.9% 169/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	21.4% 15/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	15.9% 36/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Psychiatric disorders Depression	7.5% 45/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	6.3% 38/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.4% 1/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	0.44% 1/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Skin and subcutaneous tissue disorders Dermatitis	2.2% 13/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.6% 16/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	5.7% 4/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.8% 4/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Skin and subcutaneous tissue disorders Eczema	5.4% 32/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	7.6% 46/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	1.4% 1/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	2.2% 5/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Skin and subcutaneous tissue disorders Erythema	5.2% 31/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.5% 27/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	0.00% 0/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	0.44% 1/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Skin and subcutaneous tissue disorders Rash	6.5% 39/597 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	10.6% 64/606 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	0.00% 0/70 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)	4.0% 9/227 • First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)