Long-Term Retention Rate of Tofacitinib in Rheumatoid Arthritis: An Italian Multicenter Retrospective Cohort Study

Abstract

Background: Tofacitinib (TOFA) was the first Janus kinase inhibitor (JAKi) to be approved for the treatment of rheumatoid arthritis (RA). However, data on the retention rate of TOFA therapy are still far from definitive. Objective: The goal of this study is to add new real-world data on the TOFA retention rate in a cohort of RA patients followed for a long period of time. Methods: A multicenter retrospective study of RA subjects treated with TOFA as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was conducted in 23 Italian tertiary rheumatology centers. The study considered a treatment period of up to 48 months for all included patients. The TOFA retention rate was assessed with the Kaplan–Meier method. Hazard ratios (HRs) for TOFA discontinuation were obtained using Cox regression analysis. Results: We enrolled a total of 213 patients. Data analysis revealed that the TOFA retention rate was 86.5% (95% CI: 81.8–91.5%) at month 12, 78.8% (95% CI: 78.8–85.2%) at month 24, 63.8% (95% CI: 55.1–73.8%) at month 36, and 59.9% (95% CI: 55.1–73.8%) at month 48 after starting treatment. None of the factors analyzed, including the number of previous treatments received, disease activity or duration, presence of rheumatoid factor and/or anti-citrullinated protein antibody, and presence of comorbidities, were predictive of the TOFA retention rate. Safety data were comparable to those reported in the registration studies. Conclusions: TOFA demonstrated a long retention rate in RA in a real-world setting. This result, together with the safety data obtained, underscores that TOFA is a viable alternative for patients who have failed treatment with csDMARD and/or biologic DMARDs (bDMARDs). Further large, long-term observational studies are urgently needed to confirm these results.

Multicenter evaluation of tofacitinib retention and safety in rheumatoid arthritis – why cardiovascular risk factors do not equate to overt risk

“…Unfortunately, we could not reliably estimate the incidence rate of AEs of special interest, due to the exceeding low count and relatively modest sample size. The main reason for discontinuation was ineffectiveness, which is also in line with earlier reports [ 12 ].…”

“…To some extent, the retention of TOFA may be higher than in other studies, but lower compared with other European cohorts (86.5% at month 12 and 78.8% at month 24 in an Italian study) [ 12 ].…”

“…In a German study, this observation was applicable even in a high CV risk cohort [ 20 ]. In Italian real-world observations, no TOFA discontinuation was caused by a CV event [ 12 ], but JAKi users with high CV risk were exposed to a higher risk of AEs [ 21 ].…”

Real-Life Comparison of Four JAK Inhibitors in Rheumatoid Arthritis (ELECTRA-i Study)

“…The analysis of data from 213 patients revealed that the retention rate of Tofacitinib was 86.5% (95% CI: 81.8–91.5%) after 12 months, 78.8% (95% CI: 78.8–85.2%) after 24 months, 63.8% (95% CI: 55.1–73.8%) after 36 months, and 59.9% (95% CI: 55.1–73.8%) after 48 months from the start of treatment. Among the analyzed factors, no predictive indicators were identified for the retention rate of Tofacitinib [ 27 ]. A third recent retrospective study evaluated patients with RA who received a JAKi (Tofacitinib, Baricitinib, Upadacitinib, or Filgotinib) from four tertiary care centers in Milan (Italy).…”

ReLiFiRa (Real Life Filgotinib in Rheumatoid Arthritis): Retrospective Study of Efficacy and Safety in Common Clinical Practice

“…Analysis of data from 213 patients revealed that the TOFA retention rate was 86.5% (95% CI: 81.8–91.5%) at month 12, 78.8% (95% CI: 78.8–85.2%) at month 24, 63.8% (95% CI: 55.1–73.8%) at month 36, and 59.9% (95% CI: 55.1–73.8%) at month 48 after initiation of treatment. None of factors analyzed, including number of prior treatments received, disease activity or duration, presence of RF and/or ACPA, and presence of comorbidities, were predictive of TOFA retention rate [ 36 ]. A third recent study retrospectively evaluated rheumatoid arthritis patients who received a JAKi (TOFA, BARI, UPA, FIL) from four tertiary care centers in Milan.…”