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Non-invasive predictors of maintaining remission in patients with moderately to severely active UC treated with tofacitinib who dose reduced from tofacitinib 10mg BID to 5mg BID: 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 study (NCT01470612) and had been in stable remission for ≥6 months and corticosteroid-free for ≥4 weeks prior to enrollment.


To determine if fecal calprotectin (FCP), C-reactive protein (CRP), or partial Mayo score (PMS) can be used as predictors of maintaining remission after dose reduction.


Median FCP and CRP levels, and mean PMS, at baseline, Month (M)1, and M3, were analyzed by M6 efficacy endpoint status in pts who dose-reduced to tofacitinib 5mg BID. The proportions of pts who achieved M6 efficacy endpoints were analyzed by stool frequency (SF) subscore, rectal bleeding (RB) subscore, and modified PMS (mPMS).


In tofacitinib 5mg BID-treated pts (n=70), PMS was relatively stable over time in pts in modified Mayo (mMayo) remission (endoscopic subscore ≤1 with SF subscore ≤1 and RB subscore 0) at M6 (mean [standard deviation]: baseline 0.3 [0.5]; M1 0.4 [0.7]; M3 0.4 [0.8]); vs pts who were not (0.6 [0.6]; 1.1 [1.3]; 1.3 [1.3]). Median FCP levels did not change from baseline to M3 in pts in M6 mMayo remission (median change from baseline [interquartile range] 0.0 [-48.5–40.5]), whereas FCP levels increased in pts not in M6 mMayo remission (30.0 [-53.5–429.0]). No trend was observed in median CRP levels over time.
Rates of mMayo remission at M6 were numerically higher in pts with a SF subscore, RB subscore, or mPMS of 0 at M1 or M3 vs pts with a SF subscore, RB subscore, or mPMS >0 (SF=0: M1 83.3%; M3 91.1% vs SF>0: M1 68.4%; M3 68.4%; RB=0: M1 82.5%; M3 86.4% vs RB>0: M1 25.0%; M3 60.0%; mPMS=0: M1 87.0%; M3 92.9% vs mPMS>0: M1 61.9%; M3 68.2%).


In pts previously in stable remission, an increase in FCP levels at M3 or PMS as early as M1 may help to predict loss of efficacy after dose-reduction from tofacitinib 10 to 5mg BID. A SF subscore, RB subscore, or mPMS of 0 at M1 or M3 could indicate the likelihood of maintaining efficacy with tofacitinib 5mg BID at M6. Analyses were post hoc and limited by the small sample size.


Ulcerative colitis, Tofacitinib, CRP, FCP, PMS


Gastroenterologia - Intestino


Marla C Dubinsky, Miguel Regueiro, Genoile O Santana, Joana Torres, Nicole Kulisek, Sean Gardiner, Rajiv Mundayat, Jerome Paulissen, Nervin Lawendy, Chinyu Su, Irene Modesto, William J Sandborn