Rinvoq induces endoscopic remission in Crohn’s
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Rinvoq, an oral selective Janus kinase 1 inhibitor, helped induce endoscopic remission in patients with moderate-to-severe Crohn’s disease, according to study results.
Julian Panes, MD, professor of medicine at Hospital Clínic Barcelona, and colleagues wrote that current therapies like corticosteroids and immunosuppressants are not always effective in some patients.
“There remains an unmet need for additional targeted therapies for CD that provide short and long-term benefits as measured by both patients’ symptoms and endoscopic outcomes,” they wrote.
Researchers conducted a double-blind, phase 2 trial comprising 220 adults with moderate-to-severe CD who had inadequate response or intolerance to immunosuppressants or anti-TNF therapy. They randomly assigned patients to groups that received placebo or 3 mg, 6 mg, 12 mg, or 24 mg of Rinvoq (upadacitinib, AbbVie) twice daily, or 24 mg once daily. They evaluated patients by ileocolonoscopy at weeks 12 and 16. Patients who completed week 16 went on to a randomized, 36-week maintenance phase with upadacitinib.
The primary outcomes of the study were clinical remission at week 16 and endoscopic remission at week 12 or 16.
After 16 weeks, Panes and colleagues found that 13% of patients receiving 3 mg upadacitinib, 27% of patients receiving 6 mg upadacitinib, 11% of patients receiving 12 mg upadacitinib, and 22% of patients receiving 24 mg upadacitinib twice daily, and 14% of patients receiving 24 mg upadacitinib once daily achieved clinical remission, compared with 11% of patients who received placebo.
In the endoscopic assessment, no patients who received placebo achieved endoscopic remission vs. 10% in the 3-mg group, 8% in both the 6-mg and 12-mg groups, 22% 24-mg group and 14% 24-mg once daily group. The drug’s efficacy was maintained through week 52 for most endpoints.
In their safety assessment, researchers observed that patients in the upadacitinib groups had higher incidences of infections and serious infections compared with placebo. Additionally, patients in the 12-mg and 24-mg groups had increases in total, HDL and LDL cholesterol compared with patients in the placebo group.
Panes and colleagues wrote that their findings showed that upadacitinib was superior to placebo in inducing endoscopic improvements in patients with CD refractory to biologics.
“Furthermore, after achievement of response during a 16-week induction period, maintenance therapy with upadacitinib led to sustained clinical, endoscopic and patient reported benefits,” they wrote. “Upadacitinib safety and efficacy in moderately to severely active CD will be further characterized in the phase 3 program.” – by Alex Young
Disclosure: Panes reports receiving consulting fees from AbbVie, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Genentech, GlaxoSmithKline, Janssen, MSD, Nestle, Oppilan, Progenity, Pfizer, Robarts, Roche, Second Genome, Takeda, Theravance, TiGenix, and Topivert; speaker fees from AbbVie, Biogen, Ferring, Janssen, MSD, Shire Pharmaceuticals, Takeda, and Tillotts; and research funding from AbbVie and MSD. Please see the full study for all other authors’ relevant financial disclosures.
Perspective
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Benjamin Click, MD
This is an exciting study for multiple reasons. First and foremost, this is a study of a novel selective Janus kinase 1 inhibitor, which is further improvement upon our existing armamentarium. Secondly, this study demonstrates efficacy of this compound in a rather refractory Crohn’s population, which is a very challenging population to care for. The outcomes of this study provide a lot of enthusiasm for the future. One potential thing to monitor moving forward is the safety signal. In this study, they did see a higher rate of infections and adverse events in the upadacitinib -treated group. We will have to keep an eye on the safety profile of this agent as it moves into the phase three studies. Overall, this study provides a lot of enthusiasm for a novel agent in the treatment of refractory Crohn's disease.
Cleveland Clinic
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