Reumatologia: pesquisas atuais
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Januskinase Inhibitors to Treat Rheumatoid Arthritis: Real World Data Match Clinical Trial Results. An Evaluation by BioReg, the Austrian Registry for Biologicals, Biosimilars, and Targeted Synthetic DMARDS in the Treatment of Inflammatory Rheumatic Diseases

Burkhard F. Leeb*, Peter Spellitz, Gabriele Eichbauer-Sturm, Manfred Herold, Miriam Stetter, Rudolf Puchner, Franz St. Singer, Ruth Fritsch-Stork

Background: Whether the safety and efficacy of Januskinase Inhibitors (JAKis) in daily routine treatment of Rheumatoid Arthritis (RA) match the respective clinical trial results is of crucial clinical interest, however, growing, but still limited corresponding evidence is available.

Patients and methods: Data, including adverse events, disease activity scores, patient-related outcomes, and response as well as persistence rates, of all RA patients receiving JAKi treatment registered in the BioReg database were retrieved. The results were described according to those of pivotal clinical trials of JAKis. Analyses were performed using descriptive statistics, such as mean value comparisons, and by drawing patient trajectories.

Results: One-hundred-and twenty-two patients (mean age 64 years; 83.9% female, 60.5% Rheumatoid Factor (RF) positive; n=74 receiving Baricitinib and n=48 receiving Tofacitinib) were included from 2017 on. Significant differences occurred in the initial disease activity (mean Disease Activity Score including 28-joint-count (DAS28) 6.5 versus 3.8) between the trials and real-world data. In the registry, an insufficient response was observed in 24 (32.4%) and 21 (43.8%) patients, adverse events occurred in 16 (21.6%), and 12 (25.0%); the mean duration of treatment was 1.34 yrs. and 1.5 years. in patients receiving Baricitinib and Tofacitinib, respectively. The response rates were like those of the clinical trials, whereas adverse events were less frequently reported in the registry and no safety signals occurred. All scores applied showed a positive course and the results of mean value analysis and patient trajectories demonstrated the benefits of JAKis; the health assessment questionnaire values remained relatively stable, in contrast to the trial results.

Conclusion: Real World data for JAKis comply to a high extent with clinical trial results. This may contribute to an increased confidence in the therapeutic status of these drugs.