Artikel
Safety profile of baricitinib in patients with active rheumatoid arthritis: an integrated analysis
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Veröffentlicht: | 4. September 2017 |
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Gliederung
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Background: Baricitinib (bari) (an oral janus kinase [JAK]1/JAK2 inhibitor) is in development for patients (pts) with active rheumatoid arthritis (RA). To assess the safety of bari in pts with active RA across 8 completed studies (4 phase 3, 3 phase 2, 1 phase 1b) and 1 ongoing long-term extension study).
Methods: Primary safety analysis was based on 6 studies (all with bari 4-mg once daily [QD] and placebo [PBO] arms) and dose response assessments on 4 studies (all with bari 2- and 4-mg QD and PBO arms). In addition, the “all-bari” RA set included all pts exposed to any bari dose. Two studies contained active comparators.
Results: In total, 3464 pts were exposed to bari (4214 patient-years [PY]; 2166 pts [62.5%] >1 year; 467 [13.5%] >2 years). In controlled periods of the program, no increases in deaths, adverse events leading to study drug discontinuation, malignancies, major adverse cardiac events, or serious infections were seen for bari versus PBO/active treatment. Herpes zoster was reported more frequently for bari vs PBO. In randomised, controlled periods of the program, tuberculosis (TB) was reported in 2 pts: 1 bari 4 mg, 1 adalimumab; in uncontrolled periods, 6 TB events were reported (bari 4 mg: 2 with incomplete TB screening, 3 without organism confirmed). All TB occurred in endemic areas. Two gastrointestinal perforations were reported (0.05/100 PY). Bari treatment has been associated with changes in selected hematology/clinical chemistry analytes; few pts (<1%) discontinued due to abnormal laboratory results. There was no increased risk over time for the above outcome measures with prolonged exposure.
Conclusion: In the context of reported efficacy, bari had an acceptable safety profile in pts with moderately to severely active RA.