November 01, 2016
2 min read

Baricitinib improved patient reported outcomes in phase 3 trial

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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.