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Tofacitinib as Induction and Maintenance Therapy in Japanese Patients with Active Ulcerative Colitis.

ABSTRACT: Background:Tofacitinib is an oral, small molecule Janus kinase inhibitor approved in Japan for the treatment of ulcerative colitis (UC). Differences in the safety profile of tofacitinib in Japanese patients versus the global population, such as a higher risk of herpes zoster, have been reported. Objectives:We conducted post hoc analyses of tofacitinib treatment in Japanese patients with moderate-to-severe UC in two global phase III studies. Methods:In OCTAVE Induction 1 (NCT01465763), 62 patients were randomized to placebo or tofacitinib 10 mg twice daily (b.i.d.). In OCTAVE Sustain (NCT01458574), 39 patients with clinical response in OCTAVE Induction 1 were re-randomized to placebo, tofacitinib 5 mg, or 10 mg b.i.d. Efficacy endpoints included: remission (primary endpoint; total Mayo score ?2; no individual subscore >1; rectal bleeding subscore 0); mucosal healing (Mayo endoscopic subscore ?1); clinical response (?30% and ?3-point decrease from induction study baseline total Mayo score; decrease in rectal bleeding subscore ?1 or absolute subscore ?1). Adverse events (AEs) and clinical laboratory parameters were recorded. Results:At week 8 of OCTAVE Induction 1, 22.4% of patients achieved remission with tofacitinib (placebo, 7.7%). At week 52 of OCTAVE Sustain, 31.3% and 66.7% of patients receiving tofacitinib 5 and 10 mg b.i.d., respectively, achieved remission (placebo, 9.1%). The occurrence of AEs or serious AEs in Japanese patients was generally similar to that in the global study population, with no new or unexpected safety risks observed. Conclusions:Although patient numbers were small, tofacitinib demonstrated numerically greater efficacy versus placebo among Japanese patients in OCTAVE Induction 1 and OCTAVE Sustain, with a safety profile consistent with that of the global study population.

SUBMITTER: Suzuki Y

PROVIDER: S-EPMC6873059 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Tofacitinib as Induction and Maintenance Therapy in Japanese Patients with Active Ulcerative Colitis.

Suzuki Yasuo Y Watanabe Mamoru M Matsui Toshiyuki T Motoya Satoshi S Hisamatsu Tadakazu T Yuasa Hirotoshi H Tabira Junichi J Isogawa Naoki N Tsuchiwata Shinichi S Arai Shoko S Hibi Toshifumi T

Inflammatory intestinal diseases 20190808 4

<h4>Background</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor approved in Japan for the treatment of ulcerative colitis (UC). Differences in the safety profile of tofacitinib in Japanese patients versus the global population, such as a higher risk of herpes zoster, have been reported.<h4>Objectives</h4>We conducted post hoc analyses of tofacitinib treatment in Japanese patients with moderate-to-severe UC in two global phase III studies.<h4>Methods</h4>In OCTAVE Induction 1 (NC ...[more]

PMID: 31768386

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Project description:BackgroundTofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis.AimTo report efficacy and infection rates in patients receiving tofacitinib induction treatment, by baseline corticosteroid status.MethodsWe evaluated efficacy and safety data from OCTAVE Induction 1&2 in patients with moderately-to-severely active ulcerative colitis who received tofacitinib 10 mg twice daily or placebo for 8 weeks, based on induction baseline oral corticosteroid use (Corticosteroid-Yes/No) and dose (< 20/ ≥ 20 mg/day). Infections of interest included serious infections, herpes zoster (HZ), and adjudicated opportunistic infections (OIs).ResultsAt OCTAVE Induction 1&2 baseline, 478/1092 (43.8%) patients were receiving corticosteroids. Tofacitinib demonstrated significant induction efficacy versus placebo for both Corticosteroid-Yes and Corticosteroid-No. With adjustment for prior tumor necrosis factor inhibitor and immunosuppressant failure, there were no statistically significant differences in remission and clinical response rates for Corticosteroid-Yes versus Corticosteroid-No. Among tofacitinib-treated patients, HZ and OIs occurred more frequently in Corticosteroid-Yes versus Corticosteroid-No, regardless of dose (< 20 mg vs. ≥ 20 mg). Infection incidence rates (regardless of severity/seriousness) during tofacitinib induction were generally similar regardless of baseline corticosteroid use. The proportion of tofacitinib-treated patients with HZ was 0.2% for Corticosteroid-No versus 1.1% for Corticosteroid-Yes < 20 mg and 1.0% for Corticosteroid-Yes ≥ 20 mg. Two out of three patients had HZ OIs.ConclusionsTofacitinib induction efficacy (clinical response and remission) was similar in baseline corticosteroid subgroups. Infections of interest were rare; HZ and OIs occurred more frequently among those receiving tofacitinib and corticosteroids versus those receiving tofacitinib without corticosteroids.Trial registrationhttp://www.Clinicaltrialsgov (NCT01465763[21/10/2011]; NCT01458951[21/10/2011]).

Dataset Information

Tofacitinib as Induction and Maintenance Therapy in Japanese Patients with Active Ulcerative Colitis.

Publications

Tofacitinib as Induction and Maintenance Therapy in Japanese Patients with Active Ulcerative Colitis.

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