Adalimumab is Effective for Inducing Clinical Remission at Week 4 Regardless of Baseline Corticosteroid Use: Pooled Analysis of Four Clinical Trials

Abstract

Purpose: We investigated the impact of baseline corticosteroid use on Week 4 clinical remission rates using data from four clinical trials of patients with moderate to severe Crohn's disease.Table: [1181] Clinical remission rates at week 4: patients with and without baseline corticosteroid useMethods: Data from EXTEND, CLASSIC I, GAIN, and CHARM were pooled for this post-hoc analysis; data were summarized for the adalimumab 160/80 mg and 80/40 mg induction regimens. Corticosteroid dosing remained stable throughout the 4 week induction period. Clinical remission (CDAI <150) rates for patients with and without baseline corticosteroid use were compared at Week 4. Nonresponder imputation was used for missing data. The mean change in CDAI score from baseline was also investigated. A t-test was performed to compare the mean change difference and a chi-square test was performed to compare the differences in proportion between the subgroups. Results: There were no significant differences in the rate of clinical remission at Week 4 following induction therapy nor in mean change from baseline in CDAI between patients receiving baseline corticosteroids vs. those who were not; one exception was observed at Week 4 which had a higher remission rate for the pooled 80/40 mg group in patients who were not receiving corticosteroids, p < 0.05 (Table). Conclusion: Baseline corticosteroids do not appear to influence the pattern of clinical remission nor changes in CDAI score from baseline after induction therapy with adalimumab. Disclosure: Dr Colombel - Advisory Committees or Review Panels: Abbott, AstraZeneca Pharmaceuticals LP, Centocor, Inc, Danone Research, Elan Pharmaceuticals, Inc, Millennium Research Group, Schering-Plough Corp, UCB, Inc.; Consulting: Abbott, ActoGeniX, Albireo Pharma: Consulting, AstraZeneca Pharmaceuticals LP, Bayer AG, Biogen Idec, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Co., Cellerix SL, Centocor, Inc., Chemocentryx, Cosmo Technologies Ltd, Danone Research, Elan Pharmaceuticals, Inc., Genentech Inc., Giuliani SpA, Given Imaging, GlaxoSmithKline, Hutchison MediPharma Limited, Milan, Millennium Research Group, Ocera Therapeutics, Inc., Pfizer Inc,, Schering-Plough Corp., UCB, Inc.; Speaking and Teaching: Abbott, Centocor, Inc, Elan Pharmaceuticals, Inc, Given Imaging Dr Rutgeerts - Consulting: Abbott, Actogenics, Bristol-Myers Squibb Co., Centocor, Inc., Genentech Inc., Italfarmako, Millennium Research Group, NovImmune, Schering-Plough Corp., UCB Pharma; Grant/Research Support: Abbott, Centocor, Inc, Schering-Plough, UCB Pharma Dr Reinisch - Consultancy: Abbott Dr Sandborn - Financial Support for Research: Abbott Laboratories, Bristol Meyers Squibb, CentocorOrthoBiotech, Genentech, Millennium Pharmaceuticals, Novartis, Pfizer, Shire Pharmaceuticals, UCB Pharma, Warner Chilcott (previously Procter & Gamble); Consultancy: ActoGenix, Abbott Laboratories (fees paid to Mayo), AGI Therapeutics, Albireo, Alfa Wassermann, AM-Pharma, Amgen, Anaphore, Astellas Pharma, Athersys, Atlantic Healthcare Limited, Axcan Pharma, BioBalance Corporation, Celegene, Bristol Meyers Squibb (fees paid to Mayo), Celek Pharmaceuticals, Cellerix, CentocorOrthoBiotech (fees paid to Mayo), Chemocentryix, CoMentis, Cosmo Technologies, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research, Elan Pharmceuticls (fees paid to Mayo), Eli Lilly, Enteromedics, Ferring Pharmaceuticals, Flexion Therapeutics, Funxional Therapeutics Limited, Genentech (fees paid to Mayo), Given Imaging, GlaxoSmithKline, KaloBios Pharmaceuticals, Merck Research Laboratories, Merck Serono, Novo Nordisk, Pfizer (fees paid to Mayo), Procter & Gamble (fees paid to Mayo), Purgenesis Technologies, Regeneron Pharmaceuticals, Salient Pharmaceuticals, Salix Pharmaceuticals, Santarus, Schering Plough Corporation, Shire Pharmaceuticals (fees paid to Mayo), Sigmoid Pharma, Sitrtis Pharmaceuticals, SLA Pharma, Takeda (fees paid to Mayo), Tillotts Pharma, UCB Pharma (fees paid to Mayo), Vascular Biogenics, Viamet Pharmaceuticals, Wyeth Dr Panes - Consultant: Abbott, Schering-Plough; Research grants: Abbott, Schering-Plough; Speakers bureau: Abbott, Schering-Plough Drs. Camez, Pollack, Thakkar, Huang, Yang, Chao, and Mulani - Employement: Abbott; Shareholder: Abbott. This research was supported by an industry grant from Abbott.