Outcomes of tofacitinib dose reduction in patients with ulcerative colitis in stable remission: a long-term follow-up of the randomized RIVETING trial
Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine
Abstract Background Tofacitinib is an oral Janus kinase inhibitor used for the treatment of ulcerative colitis. This study evaluated efficacy/safety of dose reduction to tofacitinib 5 mg twice daily (BID) versus remaining on 10 mg BID in patients in stable remission on 10 mg BID. s1 Methods RIVETING, a phase 3b/4, double-blind, randomized, parallel-group trial, enrolled patients in stable remission (≥6 months) and corticosteroid-free (≥4 weeks) who received tofacitinib 10 mg BID for ≥2 years. Efficacy was reported to month (M)30 and safety was reported throughout. s2 Results One hundred and forty patients were randomized (1:1) to tofacitinib 5 or 10 mg BID; 50.0% and 62.9%, respectively, maintained modified Mayo score remission at M30. Remission rate differences at M30 between doses were generally greater in patients with a baseline endoscopic subscore of 1 versus 0, and with versus without tumor necrosis factor inhibitor (TNFi) failure. 11/14 patients who dose-escalated from 5 to 10 mg BID following relapse recaptured remission (median 4.8 months). Serious infection and herpes zoster incidence rates were numerically higher with tofacitinib 10 versus 5 mg BID; overall, adverse event rates were generally similar between doses. s3 Conclusions Patients on tofacitinib 10 mg BID generally maintained modified Mayo score remission through M30 after reduction to 5 mg BID; most patients who relapsed recaptured remission after dose-escalating back to 10 mg BID. Efficacy was more likely
Abstract
Abstract Background Tofacitinib is an oral Janus kinase inhibitor used for the treatment of ulcerative colitis. This study evaluated efficacy/safety of dose reduction to tofacitinib 5 mg twice daily (BID) versus remaining on 10 mg BID in patients in stable remission on 10 mg BID. s1 Methods RIVETING, a phase 3b/4, double-blind, randomized, parallel-group trial, enrolled patients in stable remission (≥6 months) and corticosteroid-free (≥4 weeks) who received tofacitinib 10 mg BID for ≥2 years. Efficacy was reported to month (M)30 and safety was reported throughout. s2 Results One hundred and forty patients were randomized (1:1) to tofacitinib 5 or 10 mg BID; 50.0% and 62.9%, respectively, maintained modified Mayo score remission at M30. Remission rate differences at M30 between doses were generally greater in patients with a baseline endoscopic subscore of 1 versus 0, and with versus without tumor necrosis factor inhibitor (TNFi) failure. 11/14 patients who dose-escalated from 5 to 10 mg BID following relapse recaptured remission (median 4.8 months). Serious infection and herpes zoster incidence rates were numerically higher with tofacitinib 10 versus 5 mg BID; overall, adverse event rates were generally similar between doses. s3 Conclusions Patients on tofacitinib 10 mg BID generally maintained modified Mayo score remission through M30 after reduction to 5 mg BID; most patients who relapsed recaptured remission after dose-escalating back to 10 mg BID. Efficacy was more likely to be maintained following dose reduction in patients with baseline endoscopic subscore 0 versus 1, without versus with prior TNFi failure. Serious infection and herpes zoster incidence was higher with tofacitinib 10 versus 5 mg BID, consistent with known safety profile. s4 ClinicalTrials.gov NCT03281304 s5 Graphical abstract Graphical Abstract For image description, please refer to the figure legend and surrounding text. http://www.w3.org/1999/xlink float portrait otag093f6.webp float otag093-F6 portrait graphical