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P275. Clinical response is a meaningful endpoint in ulcerative colitis clinical studies

W. Sandborn1, B. Feagan2, C. Marano3, R. Strauss3, C. Han4, J. Johanns3, H. Zhang3, C. Guzzo3, J.-F. Colombel5, W. Reinisch6, P. Gibson7, J. Collins8, G. Jarnerot9, P. Rutgeerts10, 1University of California San Diego, United States, 2Robarts Research Institute, Canada, 3Janssen Research & Development, LLC, United States, 4Janssen Global Services LLC, United States, 5Hôpital Claude Huriez, France, 6Universitätsklinik für Innere Medizin IV, Austria, 7Alfred Hospital, Melbourne, Australia, 8Oregon Health Sciences University, United States, 9Orebro University Hospital, Sweden, 10University Hospital, Gasthuisberg, Belgium

Background

IBDQ and Mayo scores were used to evaluate meaningfulness of clinical response as a measure of efficacy in UC.

Methods

PURSUIT SC induction study of golimumab (GLM) enrolled UC pts (n = 774) with baseline (BL) Mayo scores of 6–12 inclusive, including an endoscopic subscore ≥2. Data from Mayo and IBDQ scores were summarized for pts not in clinical response, pts in clinical response, and pts in clinical remission. Clinical response was defined as a decrease from BL in Mayo score by ≥30% and ≥3 points, with decrease in rectal bleeding subscore of ≥1 or rectal bleeding subscore of 0 or 1. Clinical remission was defined as a Mayo score ≤2 points, with no individual subscore >1.

Results

Mean BL partial Mayo and IBDQ scores were similar among pts not in clinical response, in clinical response, or in clinical remission (Table). Mean change from BL partial Mayo score at wk6 for pts in clinical response and clinical remission were similar and larger than for pts not in clinical response. The majority of pts in clinical response and in clinical remission showed improvement in stool frequency and rectal bleeding subscores of the Mayo compared with fewer pts not in clinical response. Similar results were observed with mean change in IBDQ, mean change in IBDQ bowel symptom subscore, proportion of pts with clinically meaningful (>20 point) improvement in IBDQ, and proportion of pts with IBDQ remission (score ≥170).

 No clinical response at wk 6 (n = 420)Clinical response at wk 6 (n = 351)Clinical remission at wk 6 (n = 110)
BL Partial Mayo score6.1±1.46.0±1.45.8±1.5
 Change from BL at Wk 6*−0.3±1.2−3.9±1.7−5.1±1.70
Pts with improvement in   
 stool frequency subscore at Wk 620.5%78.7%89.1%
 rectal bleeding subscore at wk 627.1%84.6%86.4%
 (n = 417)(n = 350)(n = 110)
BL IBDQ score129.1±32.9129.9±34.1132.8±34.6
 Change from BL at Wk 66.8±2642.2±31.554.7±31.5
Pts with change in IBDQ >20 points at Wk 623.1%72.9%88.2%
Pts with IBDQ ≥170 at Wk 620.5%62.4%55.5%
BL IBDQ bowel subscore39.9±9.639.7±10.539.5±10.5
 Change from BL**2.8±8.716.0±10.721.1±11.0
Three patients prospectively excluded from analysis due to site misconduct.
**Mean±SD.

Conclusion

Symptomatic improvement in pts who achieved clinical response approached that of pts in clinical remission. Pts not in clinical response showed little change in symptoms. The results support clinical response as a meaningful measure of efficacy in UC.