Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069

The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.

Time frame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208

Population: The effectiveness analysis set was defined as all participants who had evaluable HAQ score during studies P12-069 and P12-707.

The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score \<3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score \< 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.

Time frame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156

Population: The effectiveness analysis set was defined as all participants who had evaluable DAS28-CRP score during studies P12-069 and P12-707.

MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level \< 121 ng/mL in men and \< 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.

Time frame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208

Population: The effectiveness analysis set was defined as all participants who had evaluable MMP-3 score during studies P12-069 and P12-707.

Adverse drug reactions (serious and non-serious) are adverse events for which the causal relationship between adalimumab and the event could not be ruled out. Adverse event was defined as any untoward or unintended medical occurrences (including abnormal laboratory findings), signs/symptoms, or diseases of the participant receiving adalimumab, regardless of causality of adalimumab treatment. Data are presented as percentage of participants.

Time frame: From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years

Population: Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.

The mTSS, a method of assessing radiographs, was used to evaluate the level of joint destruction by disease. Digitized X-rays of hands and feet were obtained and scored on a scale ranging from 0 \[no damage\] to 5 \[complete collapse or total destruction of joint\] for erosion and 0 \[no damage\] to 4 \[complete luxation of joint\] for joint space narrowing. The scores on each task were summed and averaged to derive the total mTSS score ranging from 0 \[normal\] to 380 \[maximal disease\]. Large positive change in mTSS indicated disease progression; small positive/no change indicated slowing/halting of disease progression. The mTSS score ≤ 0.5 was defined as minimal radiographic progression. Data are presented as the percentage of the participants with mTSS ≤ 0.5 and ≤ 1.5 at the end of third year of the observation period (at Week 104 of P12-707).

Time frame: 3 years

Population: The effectiveness analysis set was defined as all participants who had evaluable mTSS score during studies P12-069 and P12-707.