Real-World Experience With Janus Kinase Inhibitors in Immune-Mediated Diseases: Clinical Experience of a University Hospital

Abstract

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.Background: Several Janus kinase (JAK) inhibitors have been developed in recent years. These agents are widely applicable in clinical practice as an alternative treatment for immune-mediated diseases. While the safety and efficacy profile of these drugs has been evaluated in several randomized clinical trials and studies, very few authors have assessed safety and effectiveness under the real-world conditions of daily clinical practice. Objective: This study aims to describe the effectiveness and safety of JAK inhibitors in daily clinical practice for the treatment of immune-mediated rheumatic diseases in a university hospital. Methods: We performed a single-center observational, descriptive, retrospective study of all patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA) receiving active treatment with JAK inhibitors between March 2022 and February 2023. We recorded study variables from the clinical history for subsequent analysis using STATA 12.0 (StataCorp LLC, College Station, TX). A 95% confidence interval was applied. Results: The final analysis was performed on 64 patients (upadacitinib: 27, baricitinib: 16, tofacitinib: 13, filgotinib: eight), with a mean age of 55.69±10.78 years (60.94% females). The distribution by disease was as follows: RA, 44 (70.31%); SpA, 11 (17.18%); and PsA, eight (12.5%). A significant improvement was observed in all groups at six to 12 months, as follows: RA, remission in 48.89% and low activity in 26.67%; SpA, remission in 9.09% and low activity in 54.54%; and PsA, low activity in 87.5%. The factors most associated with poor response to treatment were activity before initiation of treatment and previous failure of biological disease-modifying antirheumatic drugs (bDMARDs). Adverse effects and complications were detected in 26.56% (SARS-CoV-2, one case; basal cell carcinoma, one case; and herpes zoster, two cases). There were no reports of cardiovascular or thromboembolic events, opportunistic infection, or tuberculosis. Conclusions: Our real-world data show that treatment with JAK inhibitors leads to a high rate of remission/low activity that remains unchanged at six to 12 months in RA, SpA, and PsA. The predictors of a poor response to JAK inhibitors in our study population were the level of activity before initiation of treatment and previous failure of bDMARDs. No cardiovascular or thromboembolic events were reported. Of note, we did record one case of severe infection, one case of basal cell carcinoma, and two cases of herpes zoster.