Newly published results of a phase 3 study of baricitinib, a once-daily oral Janus kinase inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA), show that the small-molecule drug provided greater improvements in patient-reported outcomes than either placebo or the biologic adalimumab (Humira).
Newly published results of a phase 3 study of baricitinib, a once-daily oral Janus kinase inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA), show that the small-molecule drug provided greater improvements in patient-reported outcomes (PROs) than either placebo or adalimumab (Humira). The study, funded by Eli Lilly and Incyte Corporation, is published in Annals of the Rheumatic Diseases.
The randomized, double-blind, double-dummy, placebo-controlled and active-controlled, parallel-arm, 52-week study was conducted at 281 centers in 26 countries. A total of 1307 patients were randomized to receive placebo (n = 488), baricitinib at a daily dose of 4 mg (n = 487), or subcutaneously administered adalimumab at a biweekly dose of 40 mg (n = 330) together with existing background therapy, including methotrexate. With primary analysis marked for week 12, patients receiving placebo switched to baricitinib in week 24.
PROs were prespecified as secondary objectives in the study, and included:
A 3- to 4-point change was considered a minimum clinically important difference (MCID). PROs including duration of morning joint stiffness and morning joint stiffness severity, worst tiredness, and worst joint pain numeric rating scales were recorded using a daily electronic diary from day 1 to week 12.
Health-related quality of life was assessed using Medical Outcomes Study Short-Form-36, which assesses 8 domains. The EuroQoL 5-Dimensions Health State Profile was also used, and included a descriptive system of the respondent’s health and a rating of their current health state. The Work Productivity and Activity Impairment Questionnaire-RA was used to measure overall work productivity and impairment of regular activities.
The researchers found the following:
The researchers concluded that patients with RA who were treated with baricitinib experienced greater improvement in most PROs across a variety of domains, compared with patients treated with placebo or adalimumab.
Eli Lilly, sponsor of baricitinib, received a complete response letter from the FDA in April 2017, when the regulatory agency indicated that additional data were necessary in to assess drug safety. Last week, Eli Lilly and the Incyte Corporation announced that they will resubmit their New Drug Application for the drug by the end of January 2018. If approved, baricitinib could exert further pressure on Humira, which already stands to lose RA market share to adalimumab biosimilars, 2 of which are now approved by the FDA.