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Safety and Efficacy of Baricitinib in Elderly Patients with Rheumatoid Arthritis

Fleischmann R, Alam J, Arora V, Bradley J, Schlichting DE, Muram D, Smolen JS. - RMD Open. 2017; 3(2): e000546. doi: 10.1136/rmdopen-2017-000546

In this post hoc analysis of pooled data from two randomised controlled trials, RA-BUILD and RA-BEAM, age was shown not to be a contraindication for use of baricitinib.

Patients in RA-BUILD were csDMARD-inadequate responder(IR) patients who received an oral placebo or 2 mg or 4 mg baricitinib once daily. Patients in RA-BEAM were MTX-IR patients and received an oral placebo, 4 mg baricitinib once daily or subcutaneous adalimumab every 2 weeks. Efficacy and safety of baricitinib in elderly patients (≥65 years) were compared with patients aged <50 years, and those ≥50 to <65 years. Both trials provided an overall sample size for placebo, n=716, and baricitinib 4 mg, n=714.

Efficacy was similar in patients regardless of age group. ACR 20/50/70 response rates at Week 12 for both placebo and baricitinib 4 mg were similar to those at Week 24. The proportions of patients who achieved remission or low disease activity were also similar across age groups.

Patients in the older age group reported more AEs, serious AEs and serious infections, with numerically more events reported with baricitinib treatment compared with placebo.

Although age is not a contraindication to the use of targeted therapies, including baricitinib, elderly patients with RA should be individually monitored to ensure there is a reasonable risk:benefit profile.

Keywords: JAK, Baricitinib, Clinical, Phase 3

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Upload date: November 2017

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