Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis
| Autor: | Haiying Zhang, Daniel Quirk, Stephen B. Hanauer, Chinyu Su, Deborah A Woodworth, Walter Reinisch, Nervin Lawendy, Chudy I. Nduaka, Peter D.R. Higgins, Adam S. Cheifetz, Gary S. Friedman, Remo Panaccione, Silvio Danese |
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| Přispěvatelé: | Hanauer, S, Panaccione, R, Danese, S, Cheifetz, A, Reinisch, W, Higgins, Pdr, Woodworth, Da, Zhang, Hy, Friedman, G, Lawendy, N, Quirk, D, Nduaka, Ci, Su, Cy |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Placebo Inflammatory bowel disease Gastroenterology Placebos 03 medical and health sciences 0302 clinical medicine Gastrointestinal Agents Piperidines Internal medicine Induction therapy medicine Humans Pyrroles Tofacitinib Hepatology biology business.industry C-reactive protein Induction Chemotherapy Middle Aged medicine.disease Ulcerative colitis Pyrimidines Treatment Outcome Clinical Trials Phase III as Topic 030220 oncology & carcinogenesis biology.protein Colitis Ulcerative Female 030211 gastroenterology & hepatology Stool frequency Onset of action business |
| Zdroj: | Clinical Gastroenterology and Hepatology. 17:139-147 |
| ISSN: | 1542-3565 |
| Popis: | Tofacitinib is an oral, small molecule inhibitor of JAK for the treatment of ulcerative colitis (UC). We evaluated the onset of symptom improvement in post-hoc analyses of data from 2 phase 3 trials of induction therapy with tofacitinib in patients with UC (OCTAVE Induction 1 and 2).The studies comprised patients with moderate to severe active UC who were intolerant to, or failed by previous treatment with, corticosteroids, thiopurines, and/or tumor necrosis factor (TNF) antagonists. Patients received tofacitinib (10 mg twice daily, n = 905) or placebo (n = 234) for 8 weeks. Daily Mayo stool frequency and rectal bleeding subscores were calculated using diary data from the first 15 days of therapy. We analyzed data from subgroups including failure of prior anti-TNF therapy, baseline corticosteroid use, and baseline serum levels of C-reactive protein.Mean changes were significantly greater in patients given tofacitinib vs placebo in reductions from baseline stool frequency subscore (tofacitinib: -0.27 vs placebo: -0.11; P.01), total number of daily bowel movements (-1.06 vs -0.27; P.0001), and rectal bleeding subscore (-0.30 vs -0.14; P.01) by day 3. Compared with placebo, more tofacitinib-treated patients had reductions from baseline in stool frequency subscore (by ≥1 point for tofacitinib, 241/837, 28.8% vs placebo, 39/218, 17.9%) (P.01) and rectal bleeding subscore (by ≥1 point for tofacitinib, 266/830, 32.0% vs placebo, 43/214, 20.1%) (P.01) by day 3. A consistent effect of tofacitinib was observed in all subgroups.In a post-hoc analysis of data from phase 3 trials of induction therapy with tofacitinib in patients with UC, we found significant improvements in symptoms among patients given tofacitinib compared with placebo within 3 days. These findings indicate the rapid onset of effect of this drug in patients with UC. ClinicalTrials.gov no: NCT01465763 and NCT01458951. |
| Databáze: | OpenAIRE |
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