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Oral JAK1 inhibitor upadacitinib maintains response in Crohn’s through 1 year

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Many patients with Crohn’s disease who responded to upadacitinib in the induction phase of the phase 2 CELEST study maintained response through 1 year in the study’s extension phase, according to new research presented at the 13th Congress of the European Crohn’s and Colitis Organisation.

Additional analyses of the induction phase showed significantly more patients achieved modified clinical remission as early as 4 weeks with upadacitinib (ABT-494, AbbVie) vs. placebo, and significantly more patients achieved steroid-free modified clinical remission and clinical remission with a high dose of the study drug vs. placebo.

“We are encouraged by these results showing upadacitinib’s potential as an oral treatment for patients with moderately to severely active Crohn’s disease,” Marek Honczarenko, vice president of immunology development at AbbVie, said in a press release. “We will continue to develop therapies that extend beyond symptoms and include endoscopic outcomes with a long-term aim to limit disease progression.”

As Healio Gastroenterology and Liver Disease previously reported, data from the 16-week induction phase of this double-blind randomized controlled trial were presented at DDW 2017, and showed upadacitinib effectively induced various definitions of remission in patients with Crohn’s disease (n = 220), almost all of whom had failed prior anti-tumor necrosis factor therapy. After this point, 180 responders from the induction phase entered the 36-week extension phase evaluating multiple doses through 52 weeks, 153 of whom were included in this efficacy analysis.

Julian Panés, MD, head of the gastroenterology department at the Hospital Clinic of Barcelona, Spain, and colleagues reported dose-dependent increases in rates of modified clinical remission and endoscopic remission among patients who received the study drug at 3-, 6-, and 12-mg twice daily doses. Further, they reported that rates of clinical, enhanced clinical, and endoscopic responses were generally higher among patients who received the study drug at 6- and 12-mg twice daily doses.

Investigators noted they detected no new safety signals, and that the overall safety profile was consistent with prior observations. They did not observe any dose-dependent effects for adverse events, serious adverse events and infections. Two malignancies occurred in patients who received the 12-mg twice daily dose, and no deaths occurred.

Additional induction analyses

Investigators also presented several sub-analyses of the CELEST induction data at the ECCO Congress, one of which evaluated the onset of clinical outcomes. These data showed “early and significant effects” of upadacitinib, with a significantly greater proportion of patients treated with the study drug at 6-, 12- and 24-mg twice daily doses achieving modified clinical remission as early as week 4 vs. placebo (P ≤ .05 for all). The modified clinical remission endpoint was also sustained over time at the 24-mg twice-daily dose through 16 weeks.

A separate sub-analysis evaluated steroid-free clinical and endoscopic endpoints, which showed that a significantly greater proportion of patients treated with the 24-mg twice-daily dose could stop corticosteroid therapy and achieve multiple clinical endpoints vs. placebo (P ≤ .05 for all). A numerically higher proportion could stop corticosteroids and achieve endoscopic remission at the 6-mg twice-daily dose vs. placebo, as well. – by Adam Leitenberger

References:

Panaccione R, et al. Abstract P601. Presented at: 13th Congress of ECCO; Feb. 14-17, 2018; Vienna.

Panés J, et al. Abstract P273. Presented at: 13th Congress of ECCO; Feb. 14-17, 2018; Vienna.

Schreiber S, et al. Abstract OP022. Presented at: 13th Congress of ECCO; Feb. 14-17, 2018; Vienna.

Disclosures: Honczarenko is employed by AbbVie. Panés reports financial relationships with AbbVie, MSD, Boehringer Ingelheim, Celgene, Genentech-Roche, GSK, Janssen, Oppilan, Takeda, Theravance, TiGenix, Arena, Nestle, Abbott, Shire and Tillotts. Please visit the ECCO website for all authors’ relevant financial disclosures.