No impact of comorbidities on efficacy, safety profiles of baricitinib in RA patients
medwireNews: Findings from a post-hoc pooled analysis suggest that comorbidity does not influence the efficacy or safety of baricitinib 4 mg once daily in patients with rheumatoid arthritis (RA) who have had an inadequate response to conventional DMARDs.
The study, published as a letter in the Annals of the Rheumatic Diseases, included five randomized trials involving a total of 803 patients treated with baricitinib and 881 given placebo.
Bernard Combe (Montpellier University, France) and colleagues found that ACR20 and 50 response rates, the proportion of patients with DAS28-CRP of 3.2 points or less, and changes in HAQ-DI score over 12 weeks in baricitinib-treated patients with and without various comorbidities – including osteoporosis and hepatic, cardiovascular, and pulmonary disorders – were “generally close to overall response rates.”
The researchers note that the exception was depression, with numerically lower baricitinib response rates observed in patients with versus without depression, but the difference did not reach statistical significance.
Evaluation of safety results from the five trials demonstrated comparable rates of treatment-emergent adverse events at week 16 among patients with and without the different comorbidities, and an additional analysis of an ongoing long-term extension study with a median follow-up of 2 years revealed similar safety results.
Combe and team caution that their study only included a limited number of comorbidities, and stress that “[f]urther studies are needed to confirm the data presented, which provide a hypothesis only.”
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