Continuous clinical response is associated with a change of disease course in patients with moderate to severe ulcerative colitis treated with golimumab

Walter Reinisch, Jean Frederic Colombel, Peter R. Gibson, Paul Rutgeerts, William J. Sandborn, Dino Tarabar, Susan Huyck, Ahmed Khalifa, Colleen Marano, George Philip, Ruji Yao, Hongyan Zhang, Freddy Cornillie

Research output: Contribution to journalArticleResearchpeer-review

2 Citations (Scopus)

Abstract

Background Responders to induction treatment sustain continuous clinical response (CCR) through 1 year in about 50% of patients in PURSUIT-M trial with golimumab maintenance in ulcerative colitis (UC). This post hoc analysis of PURSUIT-M describes the 1-year clinical, endoscopic, quality of life (QoL), and biomarker and 4-year clinical outcome in patients with sustained response to golimumab therapy for UC. Methods We compared clinical, endoscopic, QoL, and calprotectin outcomes in CCR and non-CCR patients through 54 weeks in PURSUIT-M. Persistence on golimumab therapy and clinical response at 4 years was assessed for CCR and non-CCR patients. The relationship of colectomy with CCR status was determined. Results Among patients receiving golimumab maintenance, greater proportions of patients with vs without CCR at week 54 achieved clinical remission (67.1% vs 1.9%), corticosteroid-free remission (61.6% vs 1.9%), endoscopic remission (Mayo endoscopy score 0 [47.9% vs 1.3%]), and normal QoL (inflammatory bowel disease questionnaire score ≥170 [75.0% vs 24.4%]). CCR but not non-CCR patients maintained normalized calprotectin levels during maintenance. Among patients who entered the long-term extension study, a greater proportion of patients with vs without CCR maintained PGA 0 through week 216 (58% vs 42%). Colectomy was performed in 47 induction nonresponders and in 13 induction responders. None of the patients going onto colectomy achieved CCR through 54 weeks in PURSUIT-M. Conclusions Continuous clinical response is associated with favorable short- A nd long-term clinical, endoscopic, QoL, and biomarker responses that may result in changing the course of disease and may prevent colectomy in patients with moderate to severe UC treated with golimumab.

Original languageEnglish
Pages (from-to)163-171
Number of pages9
JournalInflammatory Bowel Diseases
Volume25
Issue number1
DOIs
Publication statusPublished - 1 Jan 2019
Externally publishedYes

Keywords

  • colectomy
  • continuous clinical response
  • endoscopic healing
  • golimumab
  • ulcerative colitis

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