A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and \> 2 years) and region (US and non-US).

Time frame: Baseline to Week 24

Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.

Time frame: Baseline to Week 24

Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.

Time frame: Baseline to Week 24

Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity \[symptom-free and no arthritis symptoms\] and the extreme right end maximum disease activity; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

Time frame: Baseline to Week 24

Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score \< 2.6, is reported.

Time frame: Week 24

Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.

Time frame: Week 24

Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.