Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Lyophilized 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 NCT00175877)

NCT ID: NCT00175877

Last Updated: 2020-03-26

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 Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study \[NCT00152386\] 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: 857 participants
• Primary outcome timeframe: From first dose of CZP to the end of the open-label study (approximately 7 years)
• Results posted on: 2020-03-26

Participant Flow

Enrollment of subjects started in June 2005. 121 centers in 22 countries enrolled subjects. Participant Flow refers to the Safety Set consisting of all enrolled subjects who received at least 1 dose of study medication. Of the 857 enrolled subjects, 846 subjects are included in the Safety Set. There was 1 enrolled subject who was never dosed.

The study consists of 2 populations: of subjects who failed to achieve predefined criteria in preceding study NCT00152386 who entered C87028 on Week 16 of preceding study and of those who completed Week 52 of preceding study. Due to findings of fraud at one site, data of the 10 subjects of the site were not analyzed with data from other sites.

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: Lyophilized product reconstituted to 1 ml 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	846
Overall Study COMPLETED	497
Overall Study NOT COMPLETED	349

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: Lyophilized product reconstituted to 1 ml 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	136
Overall Study Withdrawal by Subject	141
Overall Study Lost to Follow-up	9
Overall Study Lack of Efficacy	26
Overall Study Protocol Violation	15
Overall Study Other Reason	20
Overall Study AE & Other	1
Overall Study Withdrawal by subject & Other	1

Baseline Characteristics

A Study of the Safety and Effectiveness of Lyophilized 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=846 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: Lyophilized product reconstituted to 1 ml 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	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	736 Participants n=93 Participants
Age, Categorical >=65 years	109 Participants n=93 Participants
Age, Continuous	51.5 years FULL_RANGE 11.4 • n=93 Participants
Sex: Female, Male Female	701 Participants n=93 Participants
Sex: Female, Male Male	145 Participants n=93 Participants
Region of Enrollment Serbia	45 participants n=93 Participants
Region of Enrollment United States	56 participants n=93 Participants
Region of Enrollment Estonia	16 participants n=93 Participants
Region of Enrollment Slovakia	45 participants n=93 Participants
Region of Enrollment Finland	5 participants n=93 Participants
Region of Enrollment Ukraine	81 participants n=93 Participants
Region of Enrollment Lithuania	42 participants n=93 Participants
Region of Enrollment Russian Federation	102 participants n=93 Participants
Region of Enrollment Israel	24 participants n=93 Participants
Region of Enrollment Chile	11 participants n=93 Participants
Region of Enrollment France	2 participants n=93 Participants
Region of Enrollment Czech Republic	122 participants n=93 Participants
Region of Enrollment Hungary	57 participants n=93 Participants
Region of Enrollment Mexico	5 participants n=93 Participants
Region of Enrollment Canada	19 participants n=93 Participants
Region of Enrollment Argentina	122 participants n=93 Participants
Region of Enrollment Belgium	5 participants n=93 Participants
Region of Enrollment Croatia	3 participants n=93 Participants
Region of Enrollment Australia	12 participants n=93 Participants
Region of Enrollment Bulgaria	28 participants n=93 Participants
Region of Enrollment Latvia	26 participants n=93 Participants
Region of Enrollment New Zealand	18 participants n=93 Participants
Weight	73.69 kilogram (kg) STANDARD_DEVIATION 16.17 • n=93 Participants
Height	164.30 centimeter (cm) STANDARD_DEVIATION 8.88 • n=93 Participants

PRIMARY outcome

Timeframe: From first dose of CZP to the end of the open-label study (approximately 7 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 Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] 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=846 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: Lyophilized product reconstituted to 1 ml 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 7 Years

94.9 percentage of participants

PRIMARY outcome

Timeframe: From first dose of CZP to the end of the open-label study (approximately 7 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 [NCT00152386] 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=846 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: Lyophilized product reconstituted to 1 ml 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 7 Years

41.6 percentage of participants

PRIMARY outcome

Timeframe: From Entry Visit (Week 0) to the end of the study (approximately 6.5 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=846 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: Lyophilized product reconstituted to 1 ml 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

16.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 48 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 48 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=733 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: Lyophilized product reconstituted to 1 ml 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 48

87.0 percentage of participants Interval 84.4 to 89.4

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 96 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 96 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=668 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: Lyophilized product reconstituted to 1 ml 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 96

88.0 percentage of participants Interval 85.3 to 90.4

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 144 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 144 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=602 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: Lyophilized product reconstituted to 1 ml 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 144

87.9 percentage of participants Interval 85.0 to 90.4

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 192 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 192 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=537 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: Lyophilized product reconstituted to 1 ml 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 192

89.4 percentage of participants Interval 86.5 to 91.9

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 240 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.

The assessments are based on a 20 % or greater improvement from Baseline to Week 240 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=183 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: Lyophilized product reconstituted to 1 ml 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 240

82.5 percentage of participants Interval 76.2 to 87.7

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 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=841 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: Lyophilized product reconstituted to 1 ml 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

81.3 percentage of participants Interval 78.5 to 83.9

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 48 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 48 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=733 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: Lyophilized product reconstituted to 1 ml 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 48

63.0 percentage of participants Interval 59.4 to 66.5

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 96 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 96 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=668 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: Lyophilized product reconstituted to 1 ml 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 96

66.0 percentage of participants Interval 62.3 to 69.6

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 144 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 144 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=602 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: Lyophilized product reconstituted to 1 ml 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 144

65.4 percentage of participants Interval 61.5 to 69.2

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 192 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 192 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=537 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: Lyophilized product reconstituted to 1 ml 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 192

64.8 percentage of participants Interval 60.6 to 68.8

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 240 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.

The assessments are based on a 50 % or greater improvement from Baseline to Week 240 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=183 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: Lyophilized product reconstituted to 1 ml 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 240

58.5 percentage of participants Interval 51.0 to 65.7

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 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=841 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: Lyophilized product reconstituted to 1 ml 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

57.6 percentage of participants Interval 54.1 to 60.9

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 48 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 48 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=733 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: Lyophilized product reconstituted to 1 ml 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 48

37.7 percentage of participants Interval 34.1 to 41.3

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 96 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 96 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=668 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: Lyophilized product reconstituted to 1 ml 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 96

40.7 percentage of participants Interval 37.0 to 44.6

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 144 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 144 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=602 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: Lyophilized product reconstituted to 1 ml 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 144

41.2 percentage of participants Interval 37.2 to 45.2

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 192 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 192 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=537 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: Lyophilized product reconstituted to 1 ml 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 192

42.8 percentage of participants Interval 38.6 to 47.1

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 240 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.

The assessments are based on a 70 % or greater improvement from Baseline to Week 240 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=183 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: Lyophilized product reconstituted to 1 ml 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 240

34.4 percentage of participants Interval 27.6 to 41.8

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 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=841 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: Lyophilized product reconstituted to 1 ml 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

38.2 percentage of participants Interval 34.9 to 41.5

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Week 96 of the open-label study

Population: Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 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=661 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: Lyophilized product reconstituted to 1 ml 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 96 in Modified Total Sharp Score (mTSS)

0.95 units on a scale Standard Deviation 4.79

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 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=824 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: Lyophilized product reconstituted to 1 ml 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

-0.674 units on a scale Standard Deviation 0.640

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 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=838 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: Lyophilized product reconstituted to 1 ml 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

-2.147 hours Standard Deviation 3.846

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 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=834 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: Lyophilized product reconstituted to 1 ml 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])

-3.222 units on a scale Standard Deviation 1.511

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.

Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (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=834 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: Lyophilized product reconstituted to 1 ml 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

42.4 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 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 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=777 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: Lyophilized product reconstituted to 1 ml 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

8.813 units on a scale Standard Deviation 9.092

SECONDARY outcome

Timeframe: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Population: Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 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=777 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: Lyophilized product reconstituted to 1 ml 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

4.612 units on a scale Standard Deviation 12.592

Adverse Events

Certolizumab Pegol

Serious events: 352 serious events

Other events: 682 other events

Deaths: 0 deaths

Serious adverse events

Measure	Certolizumab Pegol n=846 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: Lyophilized product reconstituted to 1 ml 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 Iron deficiency anaemia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Anaemia	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Neutrophilia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Lymphadenitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Lymphadenopathy	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Lymphadenopathy mediastinal	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Pancytopenia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Aortic valve disease	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Atrioventricular block complete	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Ischaemic cardiomyopathy	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 pectoris	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.59% 5/846 • Number of events 7 • Adverse Events (AEs) were collected up to approximately 7 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% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Mitral valve incompetence	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Myocarditis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Arrhythmia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Atrioventricular extrasystoles	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Extrasystoles	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Arrhythmia supraventricular	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Atrial fibrillation	0.71% 6/846 • Number of events 7 • Adverse Events (AEs) were collected up to approximately 7 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 Supraventricular tachycardia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 arrest	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Arnold-Chiari malformation	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 positional	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 Macular hole	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 hernia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Pancreatitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Pancreatitis chronic	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Tooth impacted	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Hiatus hernia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Duodenal ulcer	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Femoral hernia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Gastritis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 motility disorder	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Ileus	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 Nausea	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Vomiting	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 Megacolon	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Melaena	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Lip ulceration	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Asthenia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 death	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Pyrexia	0.59% 5/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Non-cardiac chest pain	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	1.2% 10/846 • Number of events 10 • Adverse Events (AEs) were collected up to approximately 7 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 cyst	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 alcoholic	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Sarcoidosis	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Allergy to arthropod bite	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Anorectal infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Peritoneal infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.71% 6/846 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 7 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 Asymptomatic bacteriuria	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	1.3% 11/846 • Number of events 12 • Adverse Events (AEs) were collected up to approximately 7 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 Folliculitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Sialoadenitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Ear infection	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Infectious mononucleosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Escherichia infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Dacryocystitis infective	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Salpingitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Geotrichum infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Cholecystitis infective	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.59% 5/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 disseminated	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Histoplasmosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 soft tissue	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Device related infection	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Groin abscess	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Localised infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Wound infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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	0.59% 5/846 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 7 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 chronic	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Lobar pneumonia	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Lower respiratory tract infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Obstructive chronic bronchitis with acute exacerbation	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	3.4% 29/846 • Number of events 31 • Adverse Events (AEs) were collected up to approximately 7 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 Pyothorax	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Nocardiosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Condyloma acuminatum	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 salmonella	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Sepsis	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 Urosepsis	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Burn infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Furuncle	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Pyoderma	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Soft tissue infection	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Subcutaneous abscess	0.59% 5/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 staphylococcal	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Staphylococcal bacteraemia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.71% 6/846 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 7 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 streptococcal	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Streptococcal bacteraemia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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	1.1% 9/846 • Number of events 9 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Tuberculous pleurisy	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Acute sinusitis	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Acute tonsillitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Chronic sinusitis	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Chronic tonsillitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Laryngopharyngitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Nasal vestibulitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Rhinitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Sinusitis	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Tonsillitis	0.47% 4/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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	0.59% 5/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Yersinia bacteraemia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Concussion	0.47% 4/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 Traumatic brain injury	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Haemothorax	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Dislocation of joint prosthesis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Complication of device removal	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Multiple fractures	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Anastomotic ulcer	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Limb traumatic amputation	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Foot fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Hip fracture	0.35% 3/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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	0.71% 6/846 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 7 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 Tibia fracture	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Excoriation	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Polytraumatism	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 secretion	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Post procedural haemorrhage	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Seroma	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Intentional overdose	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Overdose	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Acetabulum fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Pelvic fracture	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Drug toxicity	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Vertebral injury	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Skin laceration	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Skull fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Dislocation of vertebra	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Thoracic vertebral fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Rib fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Hand fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Humerus fracture	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Radius fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.59% 5/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 Wrist fracture	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Blood creatinine increased	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Blood urea increased	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Smear cervix abnormal	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Blood creatine phosphokinase increased	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Neutrophil count decreased	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Hypercholesterolaemia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Hypoglycaemia	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Ketoacidosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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	0.83% 7/846 • Number of events 8 • Adverse Events (AEs) were collected up to approximately 7 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 Finger deformity	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Foot deformity	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Knee deformity	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Upper limb deformity	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Wrist deformity	0.12% 1/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 protusion	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 destruction	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Flank pain	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Pain in extremity	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.95% 8/846 • Number of events 9 • Adverse Events (AEs) were collected up to approximately 7 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 Osteoporotic fracture	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	4.0% 34/846 • Number of events 38 • Adverse Events (AEs) were collected up to approximately 7 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 nodule	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Scoliosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Spondylitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Synovial cyst	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Synovitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Shoulder deformity	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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) Thyroid neoplasm	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Endometrial cancer	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 stage IV	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 peritoneal neoplasm	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Lip and/ or oral cavity cancer	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Castleman's disease	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Metastases to central nervous system	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Metastases to liver	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Metastases to lung	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Myeloproliferative disorder	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Neoplasm malignant	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Meningioma	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Ovarian adenoma	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Ovarian germ cell teratoma benign	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Renal cell carcinoma stage II	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Small cell lung cancer stage unspecified	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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) Basal cell carcinoma	0.35% 3/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 skin	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Benign urinary tract neoplasm	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 cancer	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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) Vaginal cancer stage 0	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 Ischaemic cerebral infarction	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 disorder	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Cervicobrachial syndrome	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Diabetic neuropathy	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Syncope	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Syncope vasovagal	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Grand mal convulsion	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Dizziness	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Hemiparesis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Radiculopathy	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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.
Pregnancy, puerperium and perinatal conditions Pregnancy on oral contraceptive	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Bipolar disorder	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Confusional state	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Depression	0.35% 3/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 Conversion disorder	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Suicide attempt	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Stress incontinence	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Bladder prolapse	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 membranoproliferative	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 cyst	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 ureteric	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 Cervical dysplasia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Cervical polyp	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 haemorrhage	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Vaginal prolapse	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Benign prostatic hyperplasia	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Pelvic pain	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Bartholin's cyst	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Vaginal haemorrhage	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.47% 4/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 Alveolitis fibrosing	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Nasal polyps	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Emphysema	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Lung infiltration	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Hydrothorax	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.59% 5/846 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 7 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 Pneumothorax	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Acute pulmonary oedema	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.59% 5/846 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 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 Respiratory failure	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Dermatitis allergic	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Pityriasis rosea	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Pruritus generalised	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Purpura	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Rash	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Skin ulcer	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Urticaria	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Joint arthroplasty	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Synovectomy	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Brain operation	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Therapy regimen changed	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Hysterectomy	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Haematoma	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Post thrombotic syndrome	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Thrombosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.35% 3/846 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 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 Arteriosclerosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.71% 6/846 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 7 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 Trombophlebitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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% 3/846 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 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 Essential hypertension	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Orthostatic hypotension	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Rheumatoid vasculitis	0.24% 2/846 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 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 Vasculitis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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 Vena cava thrombosis	0.12% 1/846 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 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=846 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: Lyophilized product reconstituted to 1 ml 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	6.7% 57/846 • Number of events 77 • Adverse Events (AEs) were collected up to approximately 7 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 Conjunctivitis	6.5% 55/846 • Number of events 77 • Adverse Events (AEs) were collected up to approximately 7 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 Diarrhoea	7.8% 66/846 • Number of events 90 • Adverse Events (AEs) were collected up to approximately 7 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 Nausea	6.3% 53/846 • Number of events 84 • Adverse Events (AEs) were collected up to approximately 7 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	6.7% 57/846 • Number of events 76 • Adverse Events (AEs) were collected up to approximately 7 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 Gastritis	5.7% 48/846 • Number of events 59 • Adverse Events (AEs) were collected up to approximately 7 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 Pyrexia	7.0% 59/846 • Number of events 86 • Adverse Events (AEs) were collected up to approximately 7 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	17.7% 150/846 • Number of events 280 • Adverse Events (AEs) were collected up to approximately 7 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	18.7% 158/846 • Number of events 270 • Adverse Events (AEs) were collected up to approximately 7 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	16.3% 138/846 • Number of events 267 • Adverse Events (AEs) were collected up to approximately 7 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	11.7% 99/846 • Number of events 134 • Adverse Events (AEs) were collected up to approximately 7 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	10.2% 86/846 • Number of events 132 • Adverse Events (AEs) were collected up to approximately 7 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 simplex	8.4% 71/846 • Number of events 131 • Adverse Events (AEs) were collected up to approximately 7 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 Influenza	10.3% 87/846 • Number of events 115 • Adverse Events (AEs) were collected up to approximately 7 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 Sinusitis	8.5% 72/846 • Number of events 110 • Adverse Events (AEs) were collected up to approximately 7 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	7.8% 66/846 • Number of events 89 • Adverse Events (AEs) were collected up to approximately 7 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 Rhinitis	6.6% 56/846 • Number of events 75 • Adverse Events (AEs) were collected up to approximately 7 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	5.3% 45/846 • Number of events 74 • Adverse Events (AEs) were collected up to approximately 7 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 Hepatic enzyme increased	5.3% 45/846 • Number of events 73 • Adverse Events (AEs) were collected up to approximately 7 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	6.1% 52/846 • Number of events 72 • Adverse Events (AEs) were collected up to approximately 7 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	15.7% 133/846 • Number of events 225 • Adverse Events (AEs) were collected up to approximately 7 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	12.2% 103/846 • Number of events 150 • Adverse Events (AEs) were collected up to approximately 7 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	8.4% 71/846 • Number of events 119 • Adverse Events (AEs) were collected up to approximately 7 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	10.9% 92/846 • Number of events 140 • Adverse Events (AEs) were collected up to approximately 7 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 Depression	5.1% 43/846 • Number of events 54 • Adverse Events (AEs) were collected up to approximately 7 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 Cough	6.9% 58/846 • Number of events 77 • Adverse Events (AEs) were collected up to approximately 7 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 Rash	7.4% 63/846 • Number of events 84 • Adverse Events (AEs) were collected up to approximately 7 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	18.8% 159/846 • Number of events 242 • Adverse Events (AEs) were collected up to approximately 7 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