Open AccessRapid Changes in Laboratory Parameters and Early Response to Adalimumab: A Pooled Analysis From Patients With Ulcerative Colitis in Two Clinical Trials
Author(s) -
Stephen B. Hanauer,
William J. Sandborn,
Jean Fréd́eric Colombel,
Séverine Vermeire,
Joel Petersson,
Kristina Kligys,
Qian Zhou,
Andreas Lazar,
Walter Reinisch
Publication year - 2019
Publication title -
journal of crohn's and colitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.277
H-Index - 80
eISSN - 1876-4479
pISSN - 1873-9946
DOI - 10.1093/ecco-jcc/jjz031
Subject(s) - medicine , adalimumab , gastroenterology , ulcerative colitis , placebo , post hoc analysis , inflammatory bowel disease , c reactive protein , quality of life (healthcare) , clinical trial , surgery , disease , inflammation , pathology , alternative medicine , nursing
Background and Aims The efficacy and safety of adalimumab for induction and maintenance of clinical remission in patients with moderately to severely active ulcerative colitis were demonstrated in the ULTRA 1 and 2 clinical trials. This post-hoc, pooled analysis evaluated early changes in laboratory parameters, Mayo subscores, mucosal healing, and health-related quality of life. Methods Mean changes in laboratory parameters including albumin, high-sensitivity C-reactive protein, total protein, haematocrit, haemoglobin, red blood cell and platelet counts, Inflammatory Bowel Disease Questionnaire, and Short Form 36 Health Survey were evaluated from baseline to Weeks 4 and 8. Mean changes in Mayo subscores of rectal bleeding and stool frequency were evaluated from baseline to Weeks 2, 4, 6, and 8. Mucosal healing was assessed with endoscopy at baseline and Week 8. Categorical variables were evaluated with the Cochran-Mantel-Haenszel test; continuous variables were evaluated with analysis of covariance and considered significant if p <0.05. Results Treatment with adalimumab significantly improved laboratory and quality-of-life measures at Weeks 4 and 8 compared with placebo [p <0.05 and p <0.001]. Mean reductions from baseline in rectal bleeding and stool frequency were significantly larger in patients receiving adalimumab compared with placebo at Week 2 and sustained through Week 8 [p <0.01]. Normal mucosa at Week 8 was achieved by 13% of patients receiving adalimumab compared with 6% of those receiving placebo [p <0.001]. Conclusions Adalimumab resulted in rapid improvements in laboratory markers and early reductions in rectal bleeding and stool frequency. Early improvement in quality-of-life scores correlated with the clinical and laboratory findings.