Eli Lilly ($LLY) and Incyte ($INCY) have reported data from a long-term extension study of their oral JAK1/2 inhibitor, baricitinib. The extension trial tracked patients from the original study for a further 24 weeks, resulting in data that suggest effects that contributed to Lilly filing for approval of the drug are maintained for at least 48 weeks.
In the extension-phase of the trial, researchers continued to dose participants in the treatment arms of the original study with either 2 mg or 4 mg of oral baricitinib. Subjects who received placebo in the first part of the trial were switched to 4 mg doses of baricitinib for the extension. After 48 weeks, Lilly and Incyte assessed structural joint damage using x-rays again and compared the data with those generated at 24 weeks.
Researchers applied two statistical methods--linear extrapolation (LE) and last observation carried forward (LOCF)--to account for changes to the treatment and missing scores. Using LE, both doses of baricitinib achieved statistically significant reductions in the rate of progression at 24 and 48 weeks as compared to placebo. The LOCF approach only yielded a statistically significant result for the 4 mg dose.
“Together with the improvement of clinical and quality of life symptoms ... a key goal of treatment is to restrict the structural damage rheumatoid arthritis causes to joints,” Leiden University Medical Center’s Dr. Désirée van der Heijde said in a statement. “These findings have shown us that, for people with rheumatoid arthritis, baricitinib may, if approved, offer an oral option which could help them restrict joint damage over an extended period of time.”
Lilly and Incyte released the long-term extension data alongside a breakdown of the patient-reported outcomes from other Phase III trials of baricitinib, including one in which the JAK1/2 inhibitor was pitted against AbbVie’s ($ABBV) Humira. More patients in the baricitinib arm of the study reported improved physical function at 12, 24 and 52 weeks than in the Humira cohort, although the difference was small and the figures for both groups declined over time.
The data add to the case Lilly and Incyte are building around baricitinib, which was submitted to the FDA for approval earlier this year. If baricitinib clears that regulatory hurdle, it will then start to try to carve out a niche as an oral option for patients with rheumatoid arthritis.
Plenty of other companies are looking to claim their own corners of the market. Three pairs of drugmakers--GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ), Regeneron ($REGN) and Sanofi ($SNY) and Gilead ($GILD) and Galapagos ($GLPG)--all have rheumatoid arthritis programs that are around late-phase trials and beyond. The drugs may be joined by Humira biosimilars and AbbVie’s own next-generation programs that are coming down the pipeline.
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