Background Biologic agents can help achieve low disease activity or remission in patients with rheumatoid arthritis (RA) who do not respond adequately to therapy with one or two conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) (1).
Objectives To understand the prevalence of RA patients with inadequate response to therapy with 2 csDMARDs and describe time to initiation of a biologic agent for this patient population.
Methods Patients enrolled in the Corrona RA registry as of January 2015 were included in this analysis. “Inadequate response” to 2 csDMARDs was defined as being on moderate or high disease activity (CDAI >10) six months after the initiation of 2 csDMARDs. The index visit was defined as the first visit after 6m of being on moderate or high CDAI after the initiation of 2 csDMARDs. The population of biologic naïve patients at index visit, with at least 6 months of additional follow up were observed longitudinally to calculate the time to initiation of a biologic agent. Kaplan-Meier method was used to estimate the time to biologic initiation.
Results 2723 RA patients treated with 2 csDMARDs for at least 6 months were identified. At the time of the index visit: 1774 (65.1%) patients had responded to 2 csDMARDs, 192 (7.1%) had started a biologic, and 135 (4.9%) patients with inadequate response to 2 csDMARDs and did not have at least 6 months of additional follow up post-index visit. The final number of inadequate responders to 2 csDMARDs included in this analysis was 622 (22.9%) patients (79.1% female, 60.9±12.7 mean age, 9.0±9.9 mean duration of RA, 19.5±8.9 mean CDAI at index visit). The median follow up time for this population was 32.5 months. Among the 622 patients, 227 initiated a biologic during the follow up time. The median time to initiation of a biologic was 75 months (95% CI: 53–97 months). Among the 227 patients who initiated the biologic, the mean (SD) time to initiation was 17.7 (±21.7) months (figure 1). While for some patients disease activity fluctuated between low/remission and moderate/high until the initiation of a biologic agent, for 57.3% of patients remained persistently in moderate or high disease activity over the follow-up.
Conclusions A significant percentage of RA patients treated with 2 csDMARDs did not respond adequately to such therapy in the population studied. Prolonged time until the initiation of a biologic agent was noted for this patient population.
Singh JA et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care and Research DOI 10.1002/acr.22783
Acknowledgement This study is sponsored by Corrona, LLC. The Corrona, LLC. RA registry has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, Astra Zeneca, BMS, Crescendo, Genentech, Horizon Pharma USA, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. The design, study conduct, and financial support for the study was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract.
Disclosure of Interest D. Pappas Employee of: Corrona, LLC, Paid instructor for: Novartis, C. Karki Employee of: Corrona, LLC, M. Liu Employee of: Corrona, LLC, J. Kremer Shareholder of: Corrona, LLC, Consultant for: AbbVie, Amgen, BMS, Genentech, GSK, Lilly, Medimmune, Pfizer, Sanofi, Employee of: Corrona, LLC, Speakers bureau: Genentech (for non-branded talk only), J. Greenberg Shareholder of: Corrona, LLC, Consultant for: AstraZeneca, Celgene, Genentech, Janssen, Novartis and Pfizer, Employee of: Corrona, LLC, V. Garg Shareholder of: AbbVie, Inc., Employee of: AbbVie, Inc.