BIRMINGHAM, ENGLAND — Adding adalimumab therapy to existing treatment of patients with rheumatoid arthritis might be a worthwhile step to drive some patients into remission, according to a large study presented at the annual meeting of the British Society for Rheumatology.
More than one-third of 6,610 long-term rheumatoid arthritis patients achieved remission at any point in the Research in Active Rheumatoid Arthritis (ReAct) study. Remission was achieved despite an average of three prior disease-modifying antirheumatic drugs and an average disease activity score (DAS) of 6.0 at baseline.
In contrast to a clinical trial that might exclude heavily pretreated patients or those with more severe disease, this open-label, multinational study was designed “to mimic day-to-day practices as best we could,” Dr. Paul Wordsworth said.
Participants received 40 mg adalimumab (Humira, Abbott) subcutaneously every other week for 12 weeks added to existing therapy with standard disease-modifying antirheumatic drugs, glucocorticoids and/or nonsteroidal anti-inflammatory drugs.
Patients could opt to continue the adjunctive therapy beyond 12 weeks. The mean duration of adalimumab treatment was 7 months. The mean age of participants was 54 years.
Overall, 81% of the participants in the study were female.
A subset of 1,251 patients continued adalimumab up to 52 weeks. At 1 year, 13% of patients were in remission for at least 6 months, defined as achievement of American College of Rheumatology 70% improvement criteria (ACR70).
The addition of adalimumab to standard therapy led to clinical remission defined as a DAS28 below 2.6 in 38% of all patients at any time during the study.
Remission was sustained at least 6 weeks by 21% of patients. A total of 20% achieved a DAS28 below 2.6 at week 12 and 25% at last observation, said Dr. Wordsworth, professor of clinical rheumatology, Nuffield Orthopaedic Centre, Oxford, England.
Researchers also assessed patients according to the simplified disease activity index (3.3 or less was considered remission), the clinical disease activity index, and the tender and swollen joint count.
Although it is difficult to conclude from this study if duration of therapy should go beyond 12 weeks, the percentage of patients who experienced clinical remission increased beyond this time point irrespective of the assessment method, Dr. Wordsworth said.
“There was a significant proportion of patients who had remission or significant improvement after 3 months,” he added.
Dr. Wordsworth disclosed that he is a consultant for Abbott, which makes adalimumab.