Continuation of Treatment with Tofacitinib in Rheumatoid Arthritis – Real-World Clinical Practice Data
The oral Janus kinase inhibitor tofacitinib has been extensively tested in patients with rheumatoid arthritis in numerous international randomized clinical trials. According to a recently published review summarizing retrospective, prospective, and observational studies from real-world clinical practice published in 2018–2020, the treatment duration with tofacitinib is comparable to that with biological disease-modifying drugs.
Therapeutic Algorithm for Rheumatoid Arthritis
According to recent recommendations from the European League Against Rheumatism (EULAR), patients with rheumatoid arthritis (RA) who have failed treatment with at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who have at least one poor prognostic factor should initiate targeted therapy with a biological DMARD (bDMARD) or a Janus kinase (JAK) inhibitor.
Tofacitinib in Clinical Studies
Tofacitinib is an oral JAK inhibitor that preferentially blocks signaling through heterodimeric receptors associated with JAK1 and/or JAK3. It has been evaluated in a series of ORAL clinical trials, which demonstrated that tofacitinib monotherapy or combined therapy with methotrexate or another csDMARD is effective and well-tolerated in patients with RA. The safety profile of tofacitinib in monotherapy or combination therapy was consistent, with an incidence rate of adverse events leading to treatment discontinuation of 6.8 per 100 patient-years.
Real-World Data
Observational studies and data collection from patient registries complement the results of clinical trials by providing experiences from routine clinical practice. The presented review focused on these aspects, highlighting data on the continuation of treatment with tofacitinib in real-world clinical practice.
Predictors of Treatment Continuation
In a Canadian analysis of data from a patient registry (n = 3678), the overall discontinuation rate of tofacitinib during the first year of treatment was 33.3%, with 35.7% of patients discontinuing due to insufficient efficacy and 26.9% due to adverse events. It was also found that the likelihood of continuing treatment was significantly higher in biologically-naïve patients (p < 0.001), older patients (over 56 years old vs. under 45 years old; p < 0.05), and those with a longer time since diagnosis (15–19 years vs. less than 5 years; p < 0.01).
Comparison with bDMARDs
An analysis of data from the Swiss registry (806 patients treated with tofacitinib, 1862 on TNFi therapy, and 1355 treated with other bDMARDs) found a slightly lower discontinuation rate for inefficacy for tofacitinib (46%) compared to TNFi (57%) and other bDMARDs (50%). The discontinuation rate due to intolerance was, however, slightly higher for tofacitinib (30% vs. 19% for TNFi and 22% for other bDMARDs). The average duration of treatment was 25 months for tofacitinib, 17 months for TNFi, and 19 months for other DMARDs.
Conversely, a retrospective cohort analysis (650 on tofacitinib and 1300 treated with bDMARDs) from 42 Australian rheumatology clinics showed a similar median treatment duration—34 months for both tofacitinib and bDMARDs. These observations correspond with the conclusions of a review that evaluated real-world studies published up to 2018, finding that persistence on and adherence to tofacitinib therapy was generally good—comparable to patients treated with bDMARDs.
Conclusion
Retrospective and prospective studies from real-world clinical practice have demonstrated the good efficacy of tofacitinib in RA patients, consistent with the results of initial clinical trials. The treatment duration with tofacitinib was generally comparable to that with bDMARDs, and the safety profile of tofacitinib in observational studies was in line with previous observations.
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Source: Bertoldi I., Caporali R. Tofacitinib: real-world data and treatment persistence in rheumatoid arthritis. Open Access Rheumatol 2021; 13: 221–237, doi: 10.2147/OARRR.S322086.
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