Trial Outcomes & Findings for Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis (NCT NCT01078571)

Last Updated: 2011-10-28

Results Overview

The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.

Recruitment status

COMPLETED

Target enrollment

705 participants

Primary outcome timeframe

Baseline, 1, 4, 6, and 12 months

Results posted on

2011-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Adalimumab Treatment Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Overall Study STARTED	705
Overall Study Safety Population	675
Overall Study Intent-to-treat (ITT) Population	591
Overall Study COMPLETED	590
Overall Study NOT COMPLETED	115

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Treatment Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Overall Study Adverse Event	36
Overall Study Lack of effectiveness	36
Overall Study Reason not reported	21
Overall Study Withdrawal by Subject	12
Overall Study Lost to Follow-up	8
Overall Study Protocol Violation	2

Baseline Characteristics

Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab (Humira) n=591 Participants
Age Continuous	54.15 years STANDARD_DEVIATION 12.43 • n=5 Participants
Sex/Gender, Customized Female	461 participants n=5 Participants
Sex/Gender, Customized Male	127 participants n=5 Participants
Sex/Gender, Customized Gender not reported	3 participants n=5 Participants
Region of Enrollment Spain	591 participants n=5 Participants
Time from Diagnosis of Rheumatoid Arthritis	8.56 Years STANDARD_DEVIATION 6.86 • n=5 Participants
Positivity of the Rheumatoid Factor Positive for Rheumatoid Factor	460 participants n=5 Participants
Positivity of the Rheumatoid Factor Negative for Rheumatoid Factor	114 participants n=5 Participants
Positivity of the Rheumatoid Factor Rheumatoid Factor Results Unknown or Missing	17 participants n=5 Participants
Previous Rheumatoid Arthritis Treatment Had previous rheumatoid arthritis treatment	588 participants n=5 Participants
Previous Rheumatoid Arthritis Treatment No previous rheumatoid arthritis treatment	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1, 4, 6, and 12 months

Population: This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).

Outcome measures

Outcome measures
Measure	Adalimumab Treatment n=675 Participants Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks	Adalimumab (Treated for Greater Than 4 Months) Participants who had been taking adalimumab for 4 months or longer.
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment Overall: Discontinued from study due to an AE	36 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment Incidence: At least 1 SAE at Baseline	4 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 SAE at 1 month	4 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment Overall: Experienced a serious adverse event	28 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment Overall: Experienced a non-serious AE	184 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment Incidence: At least 1 AE at Baseline	53 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 AE at 1 month	49 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 AE at 4 months	50 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 AE at 6 months	47 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 AE at 12 months	51 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 SAE at 4 months	6 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 SAE at 6 months	6 Participants	—
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment -- Incidence: At least 1 SAE at 12 months	8 Participants	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.

The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (\<= 2.6), Low Disease Activity (\>2.6 to \<=3.2), Moderate Disease Activity (\>3.2 to \<= 5.1) and High Disease Activity (\>5.1). The mean change in DAS 28 score from baseline to final is presented.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment n=310 Participants Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks	Adalimumab (Treated for Greater Than 4 Months) n=281 Participants Participants who had been taking adalimumab for 4 months or longer.
Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).	1.62 Units on a scale Standard Deviation 1.61	0.21 Units on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.

The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (\<= 2.6), Low Disease Activity (\>2.6 to \<=3.2), Moderate Disease Activity (\>3.2 to \<= 5.1) and High Disease Activity (\>5.1). The percentage reduction of baseline values is presented.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment n=310 Participants Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks	Adalimumab (Treated for Greater Than 4 Months) n=279 Participants Participants who had been taking adalimumab for 4 months or longer.
Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).	0.28 Percentage reduction Standard Deviation 0.34	0.01 Percentage reduction Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline, 1, 4, 6, and 12 months

Population: This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.

The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment n=310 Participants Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks	Adalimumab (Treated for Greater Than 4 Months) n=281 Participants Participants who had been taking adalimumab for 4 months or longer.
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. -- At 1 month (n=277 and n=203)	4.11 Joints Standard Deviation 5.13	1.67 Joints Standard Deviation 3.07
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. -- At 6 months (n=269 and n=266)	2.53 Joints Standard Deviation 3.42	1.00 Joints Standard Deviation 2.02
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. -- At 12 months (n=255 and n=262)	2.46 Joints Standard Deviation 3.33	0.97 Joints Standard Deviation 2.00
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. Painful Joints at Baseline (n=310 and n =281)	7.93 Joints Standard Deviation 6.31	2.22 Joints Standard Deviation 3.39
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. -- At 4 months (n=292 and n=271)	2.99 Joints Standard Deviation 4.14	1.76 Joints Standard Deviation 2.99
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. -- At 6 months (n=269 and n=267)	2.53 Joints Standard Deviation 3.42	1.71 Joints Standard Deviation 2.86
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. Swollen Joints at Baseline (n=310 and n=281)	6.19 Joints Standard Deviation 5.01	1.39 Joints Standard Deviation 2.41
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. -- At 1 month (n=277 and n= 204)	2.94 Joints Standard Deviation 3.89	1.03 Joints Standard Deviation 2.16
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. -- At 4 months (n=292 and n=272)	2.33 Joints Standard Deviation 3.39	1.04 Joints Standard Deviation 2.10

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.

Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: \<1 = no/mild disability, 1 to 2 = moderate disability, and \>2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).

Outcome measures

Outcome measures
Measure	Adalimumab Treatment n=305 Participants Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks	Adalimumab (Treated for Greater Than 4 Months) n=280 Participants Participants who had been taking adalimumab for 4 months or longer.
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.	0.44 Units on a scale Standard Deviation 0.67	0.05 Units on a scale Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.

Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: \<1 = no/mild disability, 1 to 2 = moderate disability, and \>2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment n=297 Participants Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks	Adalimumab (Treated for Greater Than 4 Months) n=238 Participants Participants who had been taking adalimumab for 4 months or longer.
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.	0.25 Percentage change Standard Deviation 0.79	-0.09 Percentage change Standard Deviation 1.54

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: This analysis was conducted in the intent-to-treat population (591 participants total).

Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment n=310 Participants Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks	Adalimumab (Treated for Greater Than 4 Months) n=281 Participants Participants who had been taking adalimumab for 4 months or longer.
Radiological Evaluation of Rheumatoid Arthritis (RA). Total number evaluated or not reported at Baseline	310 Participant	281 Participant
Radiological Evaluation of Rheumatoid Arthritis (RA). a) Radiological erosions present	58 Participant	97 Participant
Radiological Evaluation of Rheumatoid Arthritis (RA). Total evaluated or not reported at 12 months	310 Participant	281 Participant
Radiological Evaluation of Rheumatoid Arthritis (RA). b) Radiological erosions not present	49 Participant	45 Participant
Radiological Evaluation of Rheumatoid Arthritis (RA). c) Radiological erosions unknown	135 Participant	97 Participant

Adverse Events

Adalimumab Treatment

Serious events: 28 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab Treatment n=675 participants at risk Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Cardiac disorders Acute coronary syndrome	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Cardiac disorders Acute myocardial infarction	0.30% 2/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Cardiac disorders Cardiac failure	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Cardiac disorders Pericarditis	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Gastrointestinal disorders Pancreatitis acute	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
General disorders Pain	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Hepatobiliary disorders Hypertransaminasaemia	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Abscess	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Arthritis bacterial	0.30% 2/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Bacteraemia/listeriosis	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Diarrhoea/pyrexia/salmonellosis	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Herpes zoster	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Lower respiratory tract infection	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Respiratory tract infection	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Upper respiratory tract infection	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Injury, poisoning and procedural complications Fracture	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Injury, poisoning and procedural complications Radius fracture/sternal fracture	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Nervous system disorders Cerebrovascular accident	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Nervous system disorders Dizziness	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Psychiatric disorders Anxiety	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.15% 1/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.

Other adverse events

Other adverse events
Measure	Adalimumab Treatment n=675 participants at risk Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Infections and infestations Respiratory tract infection	1.2% 8/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Infections and infestations Urinary tract infection	1.5% 10/675 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab. The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.

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