{
  "abstract": "Background: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Here, we report steroid-free efficacy and safety with tofacitinib among patients with UC who received corticosteroids at baseline of the maintenance study (OCTAVE Sustain). Methods: This analysis included patients with clinical response following OCTAVE Induction 1 and 2 who were re-randomized to receive placebo, or tofacitinib 5 or 10 mg twice daily (b.d.), in OCTAVE Sustain for 52 weeks and were receiving corticosteroids at OCTAVE Sustain baseline. Corticosteroid tapering was mandatory during OCTAVE Sustain. Rates of steroid-free remission, endoscopic improvement, and clinical response were assessed, stratified by baseline characteristics. Adverse events (AEs) were stratified by treatment and steroid-free remission status. Results: Overall, 289/593 patients had corticosteroid use at OCTAVE Sustain baseline. At week 52, steroid-free remission, endoscopic improvement, and clinical response rates were 10.9%, 11.9%, and 17.8% among patients receiving placebo, 27.7%, 29.7%, and 40.6% among patients receiving tofacitinib 5 mg b.d., and 27.6%, 29.9%, and 43.7% among patients receiving tofacitinib 10 mg b.d., respectively (non-responder imputation; all p < 0.05 tofacitinib 5 or 10 mg b.d. versus placebo). Discontinuations due to AEs were lower among patients with steroid-free remission versus without. AEs of special interest were infrequent. Conclusion: For patients with baseline corticosteroid use in OCTAVE Sustain, the odds of achieving steroid-free efficacy endpoints were significantly higher for tofacitinib versus placebo, irrespective of tofacitinib dose. There were no apparent differences in AEs of special interest by steroid-free remission status. ClinicalTrials.gov: NCT01458574",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": null,
  "arxiv": null,
  "author_total": 10,
  "authors": [
    {
      "name": "Stephan Vavricka"
    },
    {
      "name": "Thomas Greuter"
    },
    {
      "name": "Benjamin Cohen"
    },
    {
      "name": "Walter Reinisch"
    },
    {
      "name": "Flavio Steinwurz"
    },
    {
      "name": "Marc Fellmann"
    },
    {
      "name": "Xiang Guo"
    },
    {
      "name": "Nervin Lawendy"
    },
    {
      "name": "Jerome Paulissen"
    },
    {
      "name": "Laurent Peyrin‐biroulet"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/2ajfnp48sxh3d.bib",
  "cited_by": 3,
  "doi": "10.1177/17562848221090834",
  "fulltext_url": null,
  "id": "2ajfnp48sxh3d",
  "issns": [
    "1756-283X",
    "1756-2848"
  ],
  "landing_url": "https://hal.univ-lorraine.fr/hal-04168253v1",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "hal",
      "0.sdv"
    ],
    [
      "openalex",
      "1311|Inflammatory Bowel Disease"
    ]
  ],
  "openalex": "W4285244452",
  "pdf_url": "https://hal.univ-lorraine.fr/hal-04168253/document",
  "pmcid": null,
  "pmid": "35574426",
  "published": "2026-09-17",
  "publisher": "Sage Publishing",
  "ris": "https://research.draconitic.com/paper/2ajfnp48sxh3d.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:35Z",
      "native_id": "hal-04168253",
      "source": "hal",
      "url": "https://hal.univ-lorraine.fr/hal-04168253v1"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "openalex:1311|Inflammatory Bowel Disease",
      "subfield": "genetics-genomics"
    }
  ],
  "title": "Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study",
  "title_text": "Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:17:35Z",
  "url": "https://research.draconitic.com/paper/2ajfnp48sxh3d",
  "venue": "Therapeutic Advances in Gastroenterology",
  "versions": []
}