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Efficacy and Safety Data Based on Historical or Pre-Existing Conditions at Baseline for Patients with Active Rheumatoid Arthritis Who Were Treated with Baricitinib

Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. - Ann Rheum Dis. 2019. DOI: 10.1136/annrheumdis-2018-214261

In a post-hoc analysis, BARI 4 mg showed similar efficacy and safety during placebo-controlled and LTE observation periods regardless of the presence or absence of select comorbidities in RA patients.

Patients with RA have a high prevalence of comorbidities. This post-hoc analysis investigated the effect of select comorbidities (depression, osteoporosis, hepatic, cardiovascular or pulmonary disorders) on the efficacy and safety of BARI 4 mg QD in patients with moderate-to-severe active RA and inadequate response to csDMARDs.

Data from placebo-controlled periods of five BARI studies were pooled for BARI 4 mg. Data for all BARI-treated patients with two years of exposure were derived from an ongoing open-label LTE study that included patients from Phase II and III studies. Efficacy outcomes were evaluated at week 12. Interactions of comorbidity-by-treatment was analysed using logistic regression or analysis of covariance. Safety observation up to week 16 and during the LTE were summarised by MedDRA preferred terms.

Response rates, serious adverse events (SAE) and discontinuations rates in BARI treated patients with/without each comorbidity were generally similar to overall rates, although numerical differences were observed between patients with depression (lower rates), osteoporosis (higher rates) or pulmonary disorders (higher rates) and those without these comorbidities. SAEs and discontinuation rates occurred at similar rates across subgroups for BARI and placebo. Similar proportions of patients experienced ≥1 treatment emergent AEs between BARI and PBO across comorbidity subgroups. Exposure-adjusted-IR for LTE patients were lower for all safety outcomes compared to PBO-controlled periods.

Regardless of presence or absence of select comorbidities, similar efficacy and safety in RA patients were seen during the placebo-controlled and LTE observation periods for BARI 4 mg. No trend for increased risk of safety events related to comorbidity were found for BARI during two years of exposure. Further studies are thus needed to provide more insight into the long-term risk of BARI treatment.

Keywords: JAK, Baricitinib, Clinical, Safety

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Upload date: April 2019

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