Date: Sunday, November 7, 2021
Session Type: Poster Session B
Session Time: 8:30AM-10:30AM
Background/Purpose: RA patients who fail to achieve treatment targets with conventional synthetic DMARDs (csDMARDs) can be treated with biologics. Randomized controlled trials (RCTs) have shown IL-6 receptor inhibitors (IL-6i) to be superior to TNF-α inhibitors (TNFi; adalimumab) as monotherapy in biologic-naïve patients with high disease activity. There is limited research comparing the effectiveness of TNFi vs IL-6i as monotherapy or in combination with csDMARDs in biologic-experienced RA patients with moderate/high disease activity. This real-world retrospective study based on CorEvitas’ RA registry aimed to address the gap.
Methods: Adult RA patients who initiated a TNFi or IL-6i during or after January 2010 were included if they had: a history of 1 or 2 biologic/targeted synthetic DMARDs (b/tsDMARDs) prior to initiation, moderate/high disease activity at initiation, and a follow-up visit at 6 (± 3) months after initiation. Cohorts included TNFi and IL-6i initiators, both with subgroups initiating as mono- or combination (with MTX) therapy. Mixed effects regression models with random intercept for patients were used to evaluate the impact of therapy class on the following outcomes: disease burden (HAQ-DI, pain visual analog scale [VAS, 0-100], patient global assessment, and fatigue [1-item VAS, 0-100]), non‑inflammatory pain (NIP; NIP1: tender joint count [TJC, 28] – swollen joint count [SJC, 28] ≥7; NIP2: SJC /TJC  < 0.5), and clinical disease activity index (CDAI). Unadjusted and covariate-adjusted effects (β, 95% confidence interval [CI] for linear regressions and odds ratio [OR, 95% CI] for logistic regressions) were reported.
Results: Patients initiating IL-6i (n=286) vs TNFi monotherapy (n=737; Figure 1) were older (60.0 vs 55.4 years; P< 0.001), had longer history of RA (12.2 vs 10.0 years; P=0.001), higher CDAI at baseline (26.9 vs 24.9; P=0.02), and were more likely to initiate as 3rd line therapy (57.0% vs 30.9%; P< 0.001). IL-6i (n=401) vs TNFi (n=1315) combination therapy initiators had higher CDAI at baseline (26.7 vs 24.8; P=0.007) and were more likely to initiate as 3rd line therapy (56.4% vs 28.7%; P< 0.001; Table 1). There were no statistically significant differences in outcomes between IL-6i and TNFi initiators (as mono- or combination therapy). One-third of IL-6i and TNFi mono- (adjusted OR [aOR]: 0.99 [0.59, 1.67]) and combination therapy initiators (aOR: 0.96 [0.66, 1.38]) achieved low disease activity (Table 2).
Conclusion: In this real-world analysis, no significant differences were noted in the outcomes for IL-6i vs TNFi initiators (as mono- or combination therapy). Compared with prior RCTs, patients in this study were biologic‑experienced, had lower disease activity, and were unblinded to treatment, which could have contributed to a reduced difference in effectiveness between these treatments. In addition, selection of therapy in this real-world study may be influenced by factors that cannot be measured or controlled.
To cite this abstract in AMA style:Sebba A, Bingham C, Bykerk V, Fiore S, Ford K, Janak J, Pappas D, Blachley T, Dave S, Kremer J, Yu M, Choy E. Comparative Effectiveness of TNF Inhibitor vs IL-6 Receptor Inhibitor as Monotherapy or Combination Therapy with Methotrexate in Patients with Rheumatoid Arthritis: Analysis from CorEvitas’ RA Registry [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/comparative-effectiveness-of-tnf-inhibitor-vs-il-6-receptor-inhibitor-as-monotherapy-or-combination-therapy-with-methotrexate-in-patients-with-rheumatoid-arthritis-analysis-from-corevitas-ra/. Accessed January 27, 2022.
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