Among patients with rheumatoid arthritis (RA), disease duration and the number of prior disease-modifying antirheumatic drugs (DMARDs) limit the potential efficacy of adalimumab therapy, according to study results published in the Annals of the Rheumatic Diseases.
This post hoc analysis included data from 2 randomized controlled trials: DE019 (ClinicalTrials.gov Identifier: NCT00195702) and DE009 or Anti-TNF Research Study Program of the Monoclonal Antibody Adalimumab (ARMADA; conducted prior to trial registration requirement). Both trials included patients with established RA (mean duration, 11 years) receiving adalimumab plus methotrexate.
At week 24, response to therapy was evaluated using disease activity outcome measures, including the 28-joint Disease Activity Score based on C-reactive protein (DAS28[CRP]), Simplified Disease Activity Index (SDAI), Health Assessment Questionnaire Disability Index (HAQ-DI), and the percentage of patients with 20%/50%/70% improvement in American College of Rheumatology (ACR) responses. Researchers assessed associations between disease duration or number of prior DMARDs and response to therapy.
In the larger DE019 study (n=207), results indicated that a greater number of prior DMARDs (>2 vs 0 to 1) was associated with smaller improvements in DAS28(CRP) (–1.8 vs –2.2), SDAI (–22.1 vs –26.9) and HAQ-DI (–0.43 vs –0.64) from baseline to week 24.
Researchers found that patients with RA duration >10 years had higher HAQ-DI scores at week 24 compared with patients with RA duration <1 year (1.1 vs 0.7); however, the effects on DAS28(CRP) and SDAI were mixed. At week 24, researchers also found that a greater number of prior DMARDs and longer RA duration were associated with lower ACR response rates.
Data from the ARMADA trial (n=67) generally confirmed the findings from the first trial. Limitations included the post hoc nature of the study, restriction to adalimumab data, and small sample size.
“These results support recommendations that combination therapy with a biologic agent and methotrexate be initiated without delay in patients who do not have a satisfactory response to treatment with methotrexate alone,” the researchers wrote.
Disclosure: This clinical trial was supported by AbbVie Inc. Please see the original reference for a full list of authors’ disclosures.
Aletaha D, Maa J, Chen S, et al. Effect of disease duration and prior disease-modifying antirheumatic drug use on treatment outcomes in patients with rheumatoid arthritis [published online August 21, 2019]. Ann Rheum Dis. doi:10.1136/annrheumdis-2018-214918