Real-world effectiveness of tofacitinib in monotherapy or in combination with csDMARDs in patients with rheumatoid arthritis: A collaboration between Dutch registries (TOFADUDAP study)

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OBJECTIVE: To compare real-world effectiveness of tofacitinib monotherapy to adalimumab monotherapy, and tofacitinib and adalimumab in combination with csDMARDs in Rheumatoid Arthritis (RA) subgroups. METHODS: Retrospective routine care data was used from six Dutch cohorts for RA patients who initiated tofacitinib or adalimumab between 2001 and 2022. Drug survival of tofacitinib monotherapy (n = 229) was compared with that of tofacitinib combination-therapy (n = 179), adalimumab monotherapy (n = 1019) and adalimumab combination-therapy (n = 1361) using Kaplan-Meier curves and Cox regression. Drug survival was evaluated as an indirect measure of treatment persistence. Exploratory analyses assessed effect modifications by anti-citrullinated protein antibody (ACPA) status and age at treatment onset in both models. RESULTS: Patients who started tofacitinib monotherapy were older compared to other treatment groups (61 vs 55, 58 and 58 years) and had used at least one previous b/tsDMARD more often compared to the adalimumab treatment groups (36% vs 41%, 19% and 13%). Compared to tofacitinib monotherapy, the risk of drug discontinuation was similar for tofacitinib combination-therapy (aHR 1.22, 95% CI: 0.96-1.54) and adalimumab monotherapy (aHR 0.89, 95% CI: 0.73-1.09) but lower for adalimumab combination-therapy (aHR 0.78, 95% CI: 0.63-0.96). Older age was associated with significantly higher risk of drug discontinuation. No effect modification by ACPA was observed. CONCLUSION: Based on real-world data from six Dutch cohorts, drug discontinuation was higher for tofacitinib than for adalimumab, with similar outcomes with or without csDMARDs. Older age was associated with a higher risk of drug discontinuation independently of treatment group, although this finding may be influenced by factors beyond treatment effectiveness. Key Points • In a real-world setting tofacitinib was observed to have similar drug survival in mono- and combination therapy • ACPA status did not influence drug survival • Older age was related to a higher risk of drug discontinuation independently of treatment.

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