The 24-week lead-in period included 371 patients, 253 of whom were eventually approved to be in the trial due to their sustained remission status. These participants were randomized into the three trial arms: an etanercept-only arm, a methotrexate-only arm and a continued combination arm. Patient enrollment was a respective ratio of 2:2:1 during the 48-week double-blind phase. Patients with disease worsening, as assessed by specific SDAI values, received combination rescue therapy and were considered non-responders.
The primary endpoint was continued SDAI remission on a single therapy at week 48. Only 28.7% of patients in the methotrexate arm were able to maintain remission at week 48. In contrast, 49.5% of the patients in the etanercept arm had stayed in remission, as had 52.9% of patients on combination medication.
In patients with worsening disease who had needed combination rescue therapy, a high percentage were back in SDAI remission by the end of the one year study (71%, 75%, and 80% in the methotrexate, etanercept and combination arms respectively). Dr. Curtis noted that he found these numbers reassuring as a clinician, “Because the likelihood that you can regain where you were before is quite good.” Dr. Curtis also noted that if disease worsening occurs, it is most likely to happen between three to six months after therapy cessation, based on their data.
Dr. Curtis said, “Similar proportions of patients maintained remission with etanercept monotherapy as compared to continuing with [combination therapy], so the implication is that probably if you are doing that well on both treatments, you can continue etanercept, stop methotrexate, and the majority of those people are going to do just as well.”
Ruth Jessen Hickman, MD, is a graduate of the Indiana University School of Medicine. She is a freelance medical and science writer living in Bloomington, Ind.
References
- Werth V, Furie R, Romero-Díaz J, Navarra S, et al. BIIB059, a Humanized monoclonal antibody targeting blood dendritic cell antigen 2 on plasmacytoid dendritic cells, shows dose-related efficacy in a phase 2 study in participants with active cutaneous lupus erythematosus [abstract]. Arthritis Rheumatol. 2020 Oct;72(suppl 10).
- Furie R, Werth VP, Merola JF, et al. Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus. J Clin Invest. 2019 Mar 1;129(3):1359–1371.
- Curtis J, Emery P, Karis E, et al. Maintenance of remission after withdrawal of etanercept or methotrexate in patients with rheumatoid arthritis in sustained remission on combination therapy: Results from a randomized, double-blind, controlled trial [abstract]. Arthritis Rheumatol. 2020 Oct;72(suppl 10).
