Patients with active rheumatoid arthritis who are cs/bDMARD-naïve may see a greater reduction in pain and improvement in physical function on baricitinib monotherapy compared with monotherapy of tocilizumab or adalimumab.
Patients with active rheumatoid arthritis who are cs/bDMARD-naïve may see a greater reduction in pain and improvement in physical function on baricitinib monotherapy compared with monotherapy of tocilizumab or adalimumab, according to the results of a recent study presented at the 2018 ACR/ARHP Annual Meeting, October 19-24, 2018, in Chicago, Illinois.
Baricitinib monotherapy previously demonstrated superiority to methotrexate in reducing pain and improvement on the Health Assessment Questionnaire Disability Index (HAQ-DI) in csDMARD-naïve active rheumatoid arthritis patients who participated in the RA-BEGIN phase 3 clinical trial. There have been no prospective head-to-head trials comparing baricitinib monotherapy to biologic disease-modifying antirheumatic drugs in csDMARD-naïve patients with rheumatoid arthritis. Therefore, investigators led by Professor Bruno Fautrel, MD, PhD, of the University Pierre et Marie Curie, Paris, France, set out to “assess pain and HAQ-DI for baricitinib monotherapy from a randomized, methotrexate-controlled trial vs adalimumab, tocilizumab, and tofacitinib monotherapy from similar randomized, methotrexate-controlled trials in csDMARD/bDMARD-naïve patients with rheumatoid arthritis using matching-adjusted indirect comparison (MAIC),” according to the study abstract.
The team used data from the RA-BEGIN trial on those patients who were in the baricitinib 4-mg arm and weighted the data to match baseline characteristics of the adalimumab arm from the PREMIER trial, the tofacitinib 5-mg arm from the ORAL-START trial, and the tocilizumab 8-mg/kg arm from a combination of the AMBITION and FUNCTION trials. Patients in the methotrexate arms were matched between trials as well.
Weights for age and gender, as well as baseline disease scores and values of the outcome variable were determined using method of moments estimators. Mean baseline pain scores on the visual analog scale (VAS) were 58.7 to 65.2 with a 6-month mean change in score of -28.3 to 33.5 in the methotrexate arm. In addition, the investigators observed similar HAQ-DI at baseline and changes in HAQ-DI in the methotrexate arm.
The results revealed that those patients taking baricitinib had numerically greater improvement in pain over methotrexate at week 24 than those who were taking tocilizumab, adalimumab, or tofacitinib. According to the investigators, “statistically significant pain improvement were observed for baricitinib vs adalimumab and tocilizumab with all 3 matching methods [study level matching, Bucher’s method without matching adjustment, and inclusion of disease duration as an additional matching variable], but only with the Bucher method for tofacitinib.”
Those patients treated with baricitinib had significantly greater improvement in HAQ-DI at week 24 than patients on tocilizumab and adalimumab, but not tofacitinib.
According to the investigators, after adjusting for differences in baseline characteristics, this indirect comparison of studies in cs/bDMARD-naïve patients with rheumatoid arthritis indicates that patients will have a greater reduction in pain and improved physical function on baricitinib monotherapy vs. tocilizumab and adalimumab monotherapy. Although the results suggest greater pain reduction for baricitinib monotherapy vs. tofacitinib monotherapy, there were no differences in improved physical function between the 2 JAK inhibitors.
Baricitinib (Olumiant, Eli Lilly) was US Food and Drug Administration (FDA) approved in June for the treatment of moderately-to-severely active rheumatoid arthritis in adults who had an inadequate response to 1 or more tumor necrosis factor (TNF) inhibitor therapies. It can be used in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs.
Fautrel B, Zhu B, Taylor PC, van de Laar M, Emery P, de Leonardis F, Gaich CL, Nicolay C, Kadziola Z, de la Torre I, Fleischmann R. Comparative Effectiveness in Pain and HAQ-DI Improvement for Baricitinib Versus Adalimumab, Tocilizumab, and Tofacitinib Monotherapies in Csdmard-Naïve Rheumatoid Arthritis Patients: A Matching-Adjusted Indirect Comparison (MAIC) [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/comparative-effectiveness-in-pain-and-haq-di-improvement-for-baricitinib-versus-adalimumab-tocilizumab-and-tofacitinib-monotherapies-in-csdmard-naive-rheumatoid-arthritis-patients-a/. Accessed October 22, 2018.
B. Fautrel, AbbVie, Biogen, BMS, Celgene, Janssen, Eli Lilly and Company, Medac, MSD,NORDIC Pharma, Novartis, Pfizer, Roche, Sanofi-Aventis, SOBI, UCB