Background and importance Tofacitinib and baricitinib are oral Janus kinase inhibitors (JKi) approved for the treatment of rheumatoid arthritis (RA), offering an alternative in patients who have not responded or tolerated previous treatment lines because of adverse effects, complications or other reasons. In pivotal clinical trials, patients had higher DAS28-ESR than our patients and were less pretreated with biologic disease modifying antirheumatic drugs (bDMARDs). Lower effectiveness in real world compared with clinical trials has been reported. We conducted a retrospective study to evaluate effectiveness in our patients.
Aim and objectives To assess the effectiveness and safety of JKi in patients with RA in a clinical setting.
Material and methods This observational retrospective study included patients with RA in a third level hospital, from 2016 to 2019. Clinical data were collected from the hospital medical records and ‘patient and treatments registry programme’ of our local government: demographic, indications, previous and current treatments, discontinuity of treatment and reasons, effectiveness and safety data.
Clinical disease impact, defined by the disease activity score, DAS28-ESR, was evaluated during patient monitoring. Mean (SD) DAS28-ESR at baseline and at follow-up after JKi treatment were analysed.
Variance analysis (ANOVA) and the χ2 test were applied (SPSS) to evaluate treatment effect (time=0 vs follow-up data).
Results Fifty-three patients were included with a mean age of 63.9±13.3 years and 46 (86.8%) were women. Previous non-bDMARDs treatments were: methotrexate (n=39, 73.6%), leflunomide (n=34, 64.2), hydroxychloroquine (n=15, 28.3%) and sulfasalazine (n=9, 17.0%).
Disease activity was categorised as: remission (DAS28-ESR <2.6), low disease activity (2.6< DAS28-ESR <3.2), moderate disease activity(3.2< DAS28-ESR <5.1) and high disease activity (DAS28-ESR >5.1). At the beginning of the study, one patient had DAS28-ESR <2.6 (1.9%) and during the monitoring period, nine patients reached DAS28-ESR <2.6 (17.0%) at some point. Mean DAS28-ESR was 4.97±1.32 at baseline; during follow-up, mean DAS28-ESR decreased to 0.69±1.44 (10.3±30.8%) (p<0.001).
Patients were classified by treatment received: tofacitinib group (TofG (n=44, 83.0%)) and baricitinib group (BarG (n=9, 17.0%)). Number of bDMARDs used before JKi:
-TofG: 0 (n=7, 15.9%), 0–3 (n=22, 50.0%), >3 (n=15, 34.1%).
-BarG: 0 (n=2, 22.2%), 0–3 (n=3, 33.3%), >3 (n=4, 44.4%).
At follow-up, mean DAS28-ESR decreased: TofG, 0.64±1.44 (9.3±32.0%) and BarG, 0.98±1.44 (15.6±23.0%).
Twelve patients discontinued JKi: baricitinib (n=3, 33.3%) and tofacitinib (n=9, 20.5%). Reasons for discontinuation, baricitinib and tofacitinib, respectively, were due to:
-lack of effectiveness (n=2, 22.2%) and (n=5, 9.4%);
-lack of adherence (n=1, 11.1%) and (n=2, 3.8%);
-adverse effects (n=0, 0%) and (n=1, 1.9% oedema and dyspnoea); and
-patient´s choice (n=0, 0%) and (n=1, 1.9%).
Conclusion and relevance Our study suggests that JKi could be effective in real world settings after switching from other multiple bDMARDs. The results showed a modest benefit of JKi in complicated and over treated patients with diverse backgrounds, as found in daily practice.
References and/or acknowledgements No conflict of interest.
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