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Impact of prior TNFi failure and prior corticosteroid use on the maintenance of efficacy of tofacitinib following dose reduction in patients with UC who were in stable remission: 6-month data from the double-blind, randomized RIVETING study
Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). RIVETING (NCT03281304) is an ongoing, double blind, randomized, parallel-group study designed to evaluate the efficacy and safety of dose reduction to tofacitinib 5mg twice daily (BID) vs remaining on 10mg BID in patients (pts) with UC. Eligible pts had received tofacitinib 10mg BID for ≥2 consecutive years in an open-label, long-term extension (OLE) study (NCT01470612) and had been in stable remission for ≥6 months and corticosteroid-free for ≥4 weeks prior to enrollment.
To evaluate tofacitinib efficacy outcomes by number of prior tumor necrosis factor inhibitors (TNFi) failed and prior corticosteroid use.
We evaluated the efficacy of tofacitinib 5mg BID at Month (M)6 of RIVETING, based on number of prior TNFi failed (0, 1, or >1), corticosteroid use (yes/no), and corticosteroid dose (<15 and ≥15mg/day) at baseline of OCTAVE Induction 1&2 and OLE. Corticosteroids were prohibited in RIVETING.
Of 70 pts randomized to receive tofacitinib 5mg BID, 43 had no prior TNFi failure, 17 had failed with 1 TNFi, and 10 had failed with >1 TNFi. At M6, modified Mayo (mMayo) score remission (endoscopic subscore ≤1 with stool frequency subscore ≤1 and rectal bleeding subscore 0) was maintained in 79.1%, 70.6%, and 80.0% of pts who had failed with 0, 1, and >1 TNFi, respectively. Of pts who enrolled into RIVETING, 26 were receiving corticosteroids (9 received <15mg/day; 17 received ≥15mg/day) at induction baseline and 7 were receiving corticosteroids at OLE baseline. At M6, rates of mMayo score remission were numerically higher in pts with corticosteroid use at induction baseline (84.6%) vs those without (72.7%). The rate of mMayo score remission was numerically higher in pts without (77.8%) vs pts with corticosteroid use at OLE baseline (71.4%), although pt numbers were low in the corticosteroid-use group. M6 mean change from RIVETING baseline mMayo score and total Mayo score was numerically higher in pts with vs pts without corticosteroid use at induction baseline (0.7 and 1.1 vs 0.6 and 0.9, respectively) and OLE baseline (1.0 and 1.3 vs 0.6 and 0.9, respectively).
In pts who were in stable remission for >6M, efficacy endpoints were maintained following dose reduction to tofacitinib 5mg BID, regardless of prior TNFi failure or prior corticosteroid use. Analyses were post hoc and limited by small sample size.
Ulcerative colitis, Tofacitinib, Corticosteroids
Gastroenterologia - Intestino
William J Sandborn, Joana Torres, Séverine Vermeire, Paulo Gustavo Kotze, Chinyu Su, Nervin Lawendy, Jerome Paulissen, Rajiv Mundayat, Sean Gardiner, Nicole Kulisek, Irene Modesto, Marla C Dubinsky