Baricitinib in Patients with Refractory Rheumatoid Arthritis
Genovese et al. - N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247
For patients who have an inadequate response or unacceptable side effects associated with biologic DMARDs, the options for treatment beyond conventional DMARDs are limited. This phase 3 trial of the JAK 1/2 inhibitor, baricitinib, studied its efficacy in bDMARD-IR patients.
527 patients were randomized to either baricitinib 2mg, 4mg or placebo for up to 24 weeks. At week 12 the primary endpoints were tested hierarchically to control type 1 error; these endpoints were ACR20, HAQ-DI score, DAS28-CRP and SDAI of 3.3 or less. These were tested in the 4mg dose and then the 2mg dose.
At week 12, significantly more patients on the 4mg dose of baricitinib achieved ACR20 response compared with placebo, 55% vs. 27%. This was also true for improvements in HAQ-DI and DAS28-CRP but unfortunately SDAI of 3.3 or less was not significantly difference. This meant, due to the set up of the statistical analysis, the 2mg dose could not be assessed for statistical analysis in this trial. Adverse events were also significantly higher in the 4mg dose group compared with placebo but there was no significance with serious adverse events.
This study shows that a daily dose of baricitinib 4mg is associated with clinical improvement at 12 weeks of treatment. On the back of these findings, along with the other from the phase 3 programme, barcitinib was filed for regulatory review by Eli Lilly earlier this year
Unfortunately, slides for this article are not available yet. We are working to have this rectified shortly. This is due to matters outside of the CSF control.