Baricitinib Is Associated with Clinical Improvement in RA Patients

Written on 27 October 2016. Posted in Rheumatology News & Perspectives

Baricitinib is an oral selective JAK1 and JAK2 inhibitor in development for the treatment of rheumatoid arthritis.

A phase III trial investigating baricitinib for the treatment of rheumatoid arthritis has been successful: 62% of patients met the primary endpoint (20% response according to the American College of Rheumatology; ACR20), compared to 39% of patients receiving placebo.Significant improvements were also observed for other measures, including joint stiffness, joint pain, fatigue, and radiographic progression of the disease.

The baricitinib is associated with clinical improvement and inhibition of the progression of joint damage seen on radiographs in patients with rheumatoid arthritis (RA) with an inadequate response or intolerance to the conventional synthetic disease modifying antirheumatic drugs (sDMARDs).

Кey results

• The researchers observed statistically significant improvements concerning the remission according to the Disease Activity Score involving 28 joints (Disease Activity Score in 28 joints, DAS28) and the simplified index of disease activity (Simplified Disease Activity Index, SDAI). Improvement was also observed in the baricitinib group concerning the questionnaire for assessing quality of life (HAQ-DI), morning stiffness, joint pain and fatigue, compared to placebo.
• A greater number of patients achieved a ACR20 at week 12 with baricitinib 4 mg than with placebo (62% against 39% ; P ≤ 0.001).
• Radiographic progression of structural joint damage at week 24 was reduced with baricitinib compared to placebo.
• The rate of adverse events during the treatment period and serious adverse event rates (SAEs) were similar in both groups (placebo and baricitinib 4 mg: 5%; baricitinib 2 mg: 3%).
• The baricitinib was associated with a decrease in neutrophil count and an increase in low density and high density lipoprotein.

Study Design

• This phase III, double-blind trial lasted 24 weeks and examined patients aged 18 and over with active RA (≥ 6 of 68 tender joints and ≥ 6 of 66 swollen joints, high sensitivity serum C-reactive protein ≥ 3.6 mg / l [upper limit of normal: 3 mg / l]) and with insufficient response (despite prior treatment) or intolerance to sDMARDs ≥ 1 (N = 684).
• The researchers randomly assigned patients in a 1: 1: 1 to receive placebo or baricitinib (2 or 4 mg) once daily, with stratification by region and presence of joint erosions.
• The primary endpoint was the ACR20; Other endpoints included DAS28 and SDAI score ≤ 3.3.
• Funding: Eli Lilly and Co.

Why is this important?

• Many RA patients have active disease despite the conventional treatment with sDMARDs or can not tolerate therapy sDMARDs.

Tags: rheumatoid arthritis, JAK, baracitinib

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