Artikel
Safety and efficacy of baricitinib in elderly patients with moderate to severe rheumatoid arthritis
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Veröffentlicht: | 4. September 2017 |
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Background: The safety and efficacy of baricitinib (bari), an oral JAK1/JAK2 inhibitor, for the treatment of rheumatoid arthritis (RA), was evaluated in the elderly subpopulation of 2 pooled phase 3 studies.
Methods: Patients (pts) with ≥6 swollen and tender joints and no prior biologic DMARD were eligible to participate. In the RA-BUILD study, csDMARD-IR pts with hsCRP ≥3.6 mg/L were randomised to placebo (PBO) or bari (2/4 mg) once daily (QD). In RA-BEAM, methotrexate (MTX)-IR pts with erosions and hsCRP ≥6.0 mg/L were randomised to PBO, bari 4 mg QD, or adalimumab (ADA) 40 mg biweekly. Patients continued background csDMARD. The primary endpoint was ACR20 at Week (Wk) 12 for bari 4 mg vs PBO. This post hoc analysis combined data from both trials PBO (N=716) and bari 4 mg (N=714). Elderly pts were defined as those ≥65 years of age. Summary statistics are presented for pts aged <65 and ≥65 years.
Results: 249 patients ≥65 years were randomised to PBO (n=113) and bari 4 mg (n=136). The primary endpoints were met; bari showed significant differences vs PBO for ACR20 at Wk 12; all key secondary endpoints were met including mean change in DAS28, SDAI, and HAQ-DI. Efficacy measures were improved in pts <65 and ≥65 years of age. Adverse events (AEs) occurred more frequently in the elderly population compared to pts aged <65 years; however, the prevalence of serious adverse events (SAEs) and discontinuations due to AEs was not different from PBO. At 12 wks there were 2 deaths (both in PBO group <65) and cardiac events were rare, as were serious infections; there were 2 herpes zoster events (both in bari 4 mg ≥65). There was 1 SAE due to thrombophlebitis (bari 4 mg <65) and 3 due to fractures, related to falls (PBO <65, n=1; bari 4 mg <65, n=1; bari 4 mg ≥65, n=1); none of these pts discontinued the study and all events resolved.
Conclusion: In 2 phase 3 studies of bari in RA pts, age did not affect efficacy, but as expected there were more AEs in the elderly in both treatment arms.