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JAK inhibitor upadacitinib meets primary endpoints in phase 3 trial for RA
Upadacitinib, a Janus kinase inhibitor from AbbVie, met all primary and secondary endpoints in its phase 3 trial for patients with rheumatoid arthritis, according to a company press release.
“We are excited by these promising results for upadacitinib,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the release. “We are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission.”
After 12 weeks, 64% of patients who received 15-mg upadacitinib — an oral, once-daily drug for rheumatoid arthritis (RA) — achieved ACR20, which was also achieved in 66% of patients who received 30-mg upadacitinib and in 36% who received placebo. In addition, ACR50 was achieved in 38% of the 15-mg group, in 43% of the 30-mg group and in 15% of the placebo group; ACR70 was achieved in 21% of the 15-mg group, in 27% of the 30-mg group and in 6% of the placebo group. Low disease activity — defined as a DAS28-CRP less than or equal to 3.2 — was achieved in 48% of both 30-mg and 15-mg groups and in 17% of the placebo group. Clinical remission — defined as a DAS28-CRP response rate of less than 2.6 — was achieved in 31% of the 15-mg group, in 28% of the 15-mg group and in 10% of the placebo group. All endpoints had significant differences between the treatment and placebo groups.
For the safety profile, no new signals were detected compared with phase 2 trials. Serious adverse events occurred in 4% of the 15-mg group, in 3% of the 30-mg group and in 2% of the placebo group.
“We look forward to seeing the full results from our phase 3 program,” Severino said. “AbbVie’s longstanding leadership in the treatment of immune-mediated diseases provides an opportunity to build upon our understanding and develop innovative therapies to address unmet patient needs.”
Reference :
https://news.abbvie.com/article_display.cfm?article_id=11498