November 01, 2016
2 min read
Save

Baricitinib improved patient reported outcomes in phase 3 trial

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Compared with placebo, 2 mg or 4 mg of baricitinib improved most patient-reported outcomes after 24 weeks, according to phase 3 results.

“Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg compared with baricitinib 2 mg,” Josef S. Smolen, MD, in the Division of Rheumatology at the Medical University of Vienna, and colleagues wrote.

As part of the RA-BEACON trial, Smolen and colleagues performed a double-blind phase 3 study of 527 patients with rheumatoid arthritis and previously failed therapy with at least one biologic. Investigators randomized patients to receive either once-daily placebo (n = 176), 2 mg of baricitinib (n = 174) or 4 mg of the drug (n = 177). At follow-up, the researchers recorded patient-reported outcomes (PROs) which included SF-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity (PtGA), pain assessment, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Researchers compared treatments using logistic regression and covariance analysis.

Both baricitinib groups showed significant improvements for most PROs, with the 4-mg group showing superior improvement to the 2-mg cohort. At week 24, most patients treated with baricitinib reported normal physical functioning (HAQ-DI < 0.5), less fatigue (FACIT-F ≥ 3.56), improvements in PtGA, reduced pain and a shorter duration of MJS. At week 12, improvements were seen in 49% of patients taking 2 mg of baricitinib and 53% of patients taking 4 mg of baricitinib, compared with only 32% in the placebo group.

James McGill
James McGill

“We are excited to share that data from the phase 3 RA-BEACON study demonstrated baricitinib’s ability to significantly improve patient-reported outcomes, such as health-related quality of life, fatigue, pain and duration of morning joint stiffness, compared with placebo," James McGill, MD, distinguished medical fellow and global brand development leader, Lilly Bio-Medicines, told Healio Rheumatology. "These positive results reinforce baricitinib’s potential to address an unmet need for patients with rheumatoid arthritis whose previous treatment with biologics failed. RA-BEACON is one of four phase 3 trials which support the continued development of oral once-daily baricitinib for the treatment of moderate-to-severe rheumatoid arthritis.” – by Will Offit

Disclosures: Smolen reports grants from AbbVie, Janssen, Eli Lilly and Company, MSD, Pfizer and Roche. McGill is employed by Eli Lilly. Please see the full study for a list of all other relevant financial disclosures.