Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis (NCT NCT00160641)

NCT ID: NCT00160641

Last Updated: 2020-03-27

Results Overview

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 567 participants
• Primary outcome timeframe: From first dose of CZP to the end of the open-label study (approximately 6.8 years)
• Results posted on: 2020-03-27

Participant Flow

Enrollment started in December 2005. 67 centers in 13 countries enrolled subjects. Participant Flow refers to the Safety Set (SS) consisting of all enrolled subjects who received at least 1 dose of study medication. Due to fraud findings at 1 site, data of the 15 subjects of site were not analyzed with data from all other sites and not part of SS.

This Open-label Study consists of two different populations: of those subjects who failed to achieve predefined criteria in preceding study C87050 [NCT00160602] who entered C87051 on Week 16 of the preceding study and of those who completed the Week 24 assessment of the preceding study.

Participant milestones

Measure	Certolizumab Pegol All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Study STARTED	567
Overall Study COMPLETED	346
Overall Study NOT COMPLETED	221

Reasons for withdrawal

Measure	Certolizumab Pegol All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Overall Study Adverse Event	102
Overall Study Withdrawal by Subject	87
Overall Study Lost to Follow-up	8
Overall Study Lack of Efficacy	12
Overall Study Protocol Violation	3
Overall Study Other	9

Baseline Characteristics

A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Certolizumab Pegol n=567 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	486 Participants n=5 Participants
Age, Categorical >=65 years	81 Participants n=5 Participants
Age, Continuous	51.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	463 Participants n=5 Participants
Sex: Female, Male Male	104 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
Region of Enrollment Serbia	46 participants n=5 Participants
Region of Enrollment Estonia	6 participants n=5 Participants
Region of Enrollment Slovakia	30 participants n=5 Participants
Region of Enrollment Ukraine	70 participants n=5 Participants
Region of Enrollment Lithuania	43 participants n=5 Participants
Region of Enrollment Israel	17 participants n=5 Participants
Region of Enrollment Russian Federation	105 participants n=5 Participants
Region of Enrollment Czech Republic	93 participants n=5 Participants
Region of Enrollment Poland	86 participants n=5 Participants
Region of Enrollment Croatia	10 participants n=5 Participants
Region of Enrollment Bulgaria	14 participants n=5 Participants
Region of Enrollment Latvia	12 participants n=5 Participants
Weight	72.37 kilogram (kg) STANDARD_DEVIATION 14.86 • n=5 Participants
Height	165.23 centimeter (cm) STANDARD_DEVIATION 8.16 • n=5 Participants

PRIMARY outcome

Timeframe: From first dose of CZP to the end of the open-label study (approximately 6.8 years)

Population: Safety Set

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

Outcome measures

Measure

Certolizumab Pegol n=567 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years

89.1 percentage of participants

PRIMARY outcome

Timeframe: From first dose of CZP to the end of the open-label study (approximately 6.8 years)

Population: Safety Set

A SAE is any untoward medical occurrence that at any dose:

• Results in death
• Is life-threatening
• Requires in patient hospitalisation or prolongation of existing hospitalisation
• Results in persistent or significant disability/incapacity, or
• Is a congenital anomaly or birth defect
• Is as infection that requires treatment parenteral antibiotics
• Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above

First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

Outcome measures

Measure

Certolizumab Pegol n=567 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years

35.3 percentage of participants

PRIMARY outcome

Timeframe: From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)

Population: Safety Set

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device.

The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.

Outcome measures

Measure

Certolizumab Pegol n=567 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study

17.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 52 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=493 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52

81.7 percentage of participants Interval 78.0 to 85.1

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 100 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=442 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100

79.4 percentage of participants Interval 75.3 to 83.1

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 148 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=410 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148

80.2 percentage of participants Interval 76.1 to 84.0

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 196 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=367 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196

81.5 percentage of participants Interval 77.1 to 85.3

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 244 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=72 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244

88.9 percentage of participants Interval 79.3 to 95.1

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=565 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal

74.2 percentage of participants Interval 70.3 to 77.7

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 52 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=493 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52

48.9 percentage of participants Interval 44.4 to 53.4

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 100 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=442 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100

51.4 percentage of participants Interval 46.6 to 56.1

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 148 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=410 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148

51.7 percentage of participants Interval 46.8 to 56.6

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 196 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=367 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196

56.9 percentage of participants Interval 51.7 to 62.1

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 244 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=72 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244

62.5 percentage of participants Interval 50.3 to 73.6

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=565 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal

47.4 percentage of participants Interval 43.3 to 51.6

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 52 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=493 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52

26.2 percentage of participants Interval 22.3 to 30.3

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 100 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=442 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100

27.1 percentage of participants Interval 23.1 to 31.6

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 148 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=410 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148

25.6 percentage of participants Interval 21.5 to 30.1

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 196 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=367 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196

29.4 percentage of participants Interval 24.8 to 34.4

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 244 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=72 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244

31.9 percentage of participants Interval 21.4 to 44.0

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.

Outcome measures

Measure

Certolizumab Pegol n=565 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal

25.5 percentage of participants Interval 21.9 to 29.3

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 104 of the open-label study

Population: Of the 567 subjects in the Safety Set (SS), 423 are included in this analysis. Data not available for 144 subjects.

The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.

Outcome measures

Measure

Certolizumab Pegol n=423 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)

0.99 units on a scale Standard Deviation 4.99

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 560 are included in this analysis. Data not available for 7 subjects.

The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.

Outcome measures

Measure

Certolizumab Pegol n=560 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score

-0.567 units on a scale Standard Deviation 0.633

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 563 are included in this analysis. Data not available for 4 subjects.

Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.

Outcome measures

Measure

Certolizumab Pegol n=563 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness

-2.31 hours Standard Deviation 3.31

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.

DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/ hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.

Outcome measures

Measure

Certolizumab Pegol n=556 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])

-2.990 units on a scale Standard Deviation 1.408

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.

Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.

Outcome measures

Measure

Certolizumab Pegol n=556 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit

36.0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.

The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).

Outcome measures

Measure

Certolizumab Pegol n=527 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score

6.628 units on a scale Standard Deviation 8.950

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Population: Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.

The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).

Outcome measures

Measure

Certolizumab Pegol n=527 Participants All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score

4.325 units on a scale Standard Deviation 12.208

Adverse Events

Certolizumab Pegol

Serious events: 200 serious events

Other events: 383 other events

Deaths: 0 deaths

Serious adverse events

Measure	Certolizumab Pegol n=567 participants at risk All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Blood and lymphatic system disorders Anaemia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Blood and lymphatic system disorders Haemolytic anaemia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Coronary artery disease	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Cardiac failure	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Cardiac failure chronic	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Cardiac failure congestive	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Cardiopulmonary failure	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Acute myocardial infarction	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Angina unstable	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Myocardial infarction	0.71% 4/567 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Myocardial ischaemia	0.35% 2/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Bradycardia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Sick sinus syndrome	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Cardiac disorders Ventricular arrhythmia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Congenital, familial and genetic disorders Pyloric stenosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Eye disorders Cataract	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Eye disorders Uveitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Eye disorders Retinal detachment	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Gastric polyps	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Gastric ulcer	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Gastroduodenitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.53% 3/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Food poisoning	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal perforation	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Inguinal hernia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Peritonitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Gastrointestinal disorders Periproctitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
General disorders Death and sudden death	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
General disorders Sudden cardiac death	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
General disorders Hernia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
General disorders Cyst	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
General disorders Chest pain	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis acute	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis chronic	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.88% 5/567 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Hepatobiliary disorders Cryptogenic cirrhosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Hepatobiliary disorders Hepatic cirrhosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Hepatobiliary disorders Hepatitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Immune system disorders Serum sickness	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Anal abscess	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Appendicitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Diverticulitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Gastroenteritis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Arthritis bacterial	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.88% 5/567 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Gangrene	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Arthritis infective	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Bursitis infective	0.53% 3/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Osteomyelitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Borrelia infection	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Lyme disease	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Colitis pseudomembranous	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Tooth abscess	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Otitis media acute	0.35% 2/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Salpingo-oophoritis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Tubo-ovarian abscess	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Gallbladder empyema	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Herpes zoster	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Abscess limb	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Postoperative wound infection	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pneumonia klebsiella	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Bronchitis acute	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Bronchopneumonia	0.35% 2/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Embolic pneumonia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pneumonia	1.6% 9/567 • Number of events 9 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pneumonia primary atypical	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Papilloma viral infection	0.18% 1/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Carbuncle	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Diabetic foot infection	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Erysipelas	0.53% 3/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pneumococcal sepsis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pneumonia pneumococcal	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Toxic shock syndrome streptococcal	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Disseminated tuberculosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Lymph node tuberculosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Meningitis tuberculous	0.18% 1/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pulmonary tuberculosis	1.6% 9/567 • Number of events 9 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Tuberculosis	0.71% 4/567 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Tuberculosis of central nervous system	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Tuberculosis of intrathoracic lymph nodes	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Laryngitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Peritonsillar abscess	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Cystitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pyelocystitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pyelonephritis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pyelonephritis acute	0.71% 4/567 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pyelonephritis chronic	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Joint dislocation	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Stress fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Joint injury	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Meniscus lesion	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Ankle fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Femoral neck fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Femur fracture	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Lower limb fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Tendon rupture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Road traffic accident	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Postoperative hernia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Head injury	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Neck injury	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Contusion	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Spinal compression fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Thermal burn	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Sternal fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Forearm fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Ulna fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Upper limb fracture	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Investigations Transaminases increased	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Investigations Body temperature increased	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Investigations Platelet count decreased	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Investigations Chest X-ray abnormal	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Investigations White blood cell count decreased	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.88% 5/567 • Number of events 7 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Flat feet	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Lower limb deformity	0.18% 1/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Toe deformity	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.35% 2/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Joint swelling	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.53% 3/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Neck pain	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.8% 10/567 • Number of events 11 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	3.4% 19/567 • Number of events 22 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Fistula	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.35% 2/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage II	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.18% 1/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease stage III	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ganglioneuroma	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.53% 3/567 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.1% 6/567 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Acoustic neuritis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Cerebral haemorrhage	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Cerebrovascular accident	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Vertebrobasilar insufficiency	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Carpal tunnel syndrome	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Radicular syndrome	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Transient ischaemic attack	1.2% 7/567 • Number of events 9 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Vocal cord paralysis	0.18% 1/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Psychiatric disorders Mental disorder	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Renal and urinary disorders Glomerulonephritis proliferative	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Renal and urinary disorders Renal failure	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Renal and urinary disorders Haematuria	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Renal and urinary disorders Proteinuria	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Renal and urinary disorders Calculus urinary	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Renal and urinary disorders Renal colic	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Menorrhagia	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Metrorrhagia	0.53% 3/567 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Ovarian cyst	0.71% 4/567 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Colpocele	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Uterine prolapse	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Endometrial hyperplasia	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Uterine haemorrhage	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Reproductive system and breast disorders Uterine polyp	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rheumatoid lung	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Hiccups	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Surgical and medical procedures Peritoneal adhesions division	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Surgical and medical procedures Hip arthroplasty	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Surgical and medical procedures Knee arthroplasty	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Vascular disorders Hypertensive crisis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Vascular disorders Venous thrombosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Vascular disorders Venous thrombosis limb	0.35% 2/567 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Vascular disorders Varicose ulceration	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Vascular disorders Varicose vein	0.18% 1/567 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.

Other adverse events

Measure	Certolizumab Pegol n=567 participants at risk All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Infections and infestations Upper respiratory tract infection	16.0% 91/567 • Number of events 150 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	11.5% 65/567 • Number of events 99 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	10.6% 60/567 • Number of events 90 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Bronchitis acute	9.2% 52/567 • Number of events 69 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Viral infection	8.1% 46/567 • Number of events 61 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Pharyngitis	5.8% 33/567 • Number of events 48 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Infections and infestations Respiratory tract infection	5.5% 31/567 • Number of events 48 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Investigations Activated partial thromboplastin time prolonged	11.5% 65/567 • Number of events 106 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	5.1% 29/567 • Number of events 42 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	13.4% 76/567 • Number of events 146 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	7.8% 44/567 • Number of events 56 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Nervous system disorders Headache	7.8% 44/567 • Number of events 61 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
Vascular disorders Hypertension	13.6% 77/567 • Number of events 85 • Adverse Events (AEs) were collected up to approximately 6.8 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study. AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493 (UCB)

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60