Introduction Objective To evaluate long-term efficacy of adalimumab (ADA) for patients with moderately to severely active ulcerative colitis (UC).
Methods The ADA UC development programme consists of two trials (ULTRA 1 and ULTRA 2)1, 2 followed by an ongoing multicentre open-label (OL) extension. Patients entering the extension on OL weekly ADA dosing continued on same. Patients entering the extension study from any blinded cohort (ADA or placebo [PBO]) or an OL cohort receiving ADA 40mg every other week (eow) received OL ADA 40mg eow. For patients entering from a blinded cohort, increase to 40mg weekly for flare or non-response was allowed at or after week 12. For patients entering from an OL cohort, increase to 40mg weekly for flare or non-response was allowed at or after week 12 for patients in clinical response at entry, or week 2 for patients with inadequate response at entry. Adjustments to concomitant medications including corticosteroids were allowed per protocol specifications. Partial Mayo score (PMS, Mayo score without endoscopy subscore) was collected at every study visit during the lead-in trials and the OL extension. Mean PMS over time through 3 years (172 weeks) from first dose of ADA was assessed using observed case method in the “any ADA” population (patients who received at least one dose of ADA in the lead-in or extension trials) using a data cut off of 16 December 2011. The proportion of patients in clinical remission per PMS (PMS ≤2 with no subscore > 1) at week 60 of the OL extension was assessed in the intent-to-treat (ITT) population (patients enrolled in the extension, excluding patients from sites non-compliant with good clinical practises), using non-responder imputation (NRI) to handle missing data.
Results The observed mean PMS at day of first dose of ADA was 5.9 (N = 992), and decreased over time through 172 weeks of treatment to 1.5 (N = 210, Table). Of the 588 ITT patients from the lead-in studies who enrolled into the OL extension, 325 (55.3%, NRI) achieved clinical remission per PMS at week 60 of the OL extension. No new safety signals were observed.
Conclusion The results of the ongoing extension trial support clinically meaningful efficacy of adalimumab for the treatment of moderately to severely active UC, sustained for up to 3 years.
Disclosure of Interest J.-F. Colombel Shareholder of: Intestinal Biotech Development, Grant/Research Support from: AbbVie, Ferring, Merck & Co, UCB Pharma, Giuliani SPA, Consultant for: AbbVie, Amgen, Biogen Idec Inc, Boehringer-Ingelheim, Inc., Bristol Meyers Squibb, Cellerix SL, Chemocentryx, Inc., Janssen, Cosmo Technologies, Ltd, Elan Pharmaceuticals, Inc., Roche, Giuliani SPA, Given Imaging, Glaxo Smith Kline, Immune Pharmaceuticals Ltd., ISR, Merck & Co., Inc., Takeda, Neovacs SA, Ocerra Therapeutics, Inc., Pfizer Inc. Prometheus, Sanofi, Shire Pharmaceuticals, Synta Pharmaceutical Corporation, Takeda, Teva Pharmaceuticals, Therakos, TXcell, UCB Pharma, Speaker bureau with: AbbVie, Janssen, Falk Pharma, Ferring, Given Imaging, Merck & Co., Inc., Shire Pharmaceuticals, UCB Pharma, W. Sandborn Grant/Research Support from: AbbVie, Bristol Meyers Squibb, Roche, Glaxo Smith Kline, Janssen, Takeda, Novartis, Pfizer, Procter and Gamble Pharmaceuticals, Shire Pharmaceuticals, and UCB Pharma, Consultant for: AbbVie, ActoGeniX NV, AGI Therapeutics, Inc., Alba Therapeutics Corporation, Albireo, Alfa Wasserman, Amgen, AM-Pharma BV, Anaphore, Astellas Pharma, Athersys, Inc., Atlantic Healthcare Limited, Aptalis, BioBalance Corporation, Boehringer-Ingelheim Inc, Bristol Meyers Squibb, Celgene, Celek Pharmaceuticals, Cellerix SL, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research Inc., Elan Pharmaceuticals, EnGene, Inc., Eli Lilly, Enteromedics, Exagen Diagnostics, Inc., Ferring Pharmaceuticals, Flexion Therapeutics, Inc., Funxional Therapeutics Limited, Genzyme Corporation, Roche, Gilead Sciences, Given Imaging, Glaxo Smith Kline, Human Genome Sciences, Ironwood Pharmaceuticals, Janssen, KaloBios Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Lycera Corporation, Meda Pharmaceuticals, Merck Research Laboratories, Merck & Co., MerckSerono, Takeda, Nisshin Kyorin Pharmaceuticals Co., Ltd., Novo Nordisk A/S, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, Inc., PDL Biopharma, Pfizer, Procter and Gamble, Prometheus Laboratories, ProtAb Limited, Purgenesis Technologies, Inc., Receptos, Relypsa, Inc., Salient Pharmaceuticals, Salix Pharmaceuticals, Inc., Santarus, Shire Pharmaceuticals, Sigmoid Pharma Limited, Sirtris Pharmaceuticals, Inc. (a GSK company), S.L.A. Pharma (UK) Limited, Targacept, Teva Pharmaceuticals, Therakos, Zeria Pharmaceutical Co, TxCell SA, UCB Pharma, Viamet Pharmaceuticals, Vascular Biogenics Limited (VBL), Warner Chilcott UK Limited, Speaker bureau with: AbbVie, Bristol Meyers Squibb, and Janssen, D. Wolf Grant/Research Support from: AbbVie, Bristol-Myers Squibb, GIVEN Imaging, Janssen Biotech Inc, Takeda, Prometheus Laboratories, UCB Pharma, Consultant for: AbbVie, GIVEN Imaging, Janssen Biotech Inc, Takeda, Prometheus Laboratories, Salix Pharmaceuticals, UCB Pharma, Speaker bureau with: AbbVie, Janssen Biotech Inc, Prometheus Laboratories, UCB Pharma, Warner Chilcott, R. Panaccione Grant/Research Support from: AbbVie, Osiris Therapeutics, Inc, UCB, Inc, Consultant for: AbbVie, Axcan Pharma, Inc, Biogen/IDEC, Bristol-Myers Squibb, Janssen, Chemocentryx, Elan Pharmaceuticals, Inc., Ferring Pharmaceuticals, Inc., Roche, Novartis Pharmaceuticals, Inc., PDL Biopharma, Inc., UCB, Inc, Speaker bureau with: AbbVie, Janssen, Elan Pharmaceuticals, Inc., Medscape, A. Lazar Shareholder of: May own Abbott and/or AbbVie stock, Employee of: AbbVie, M. Kron Shareholder of: May own Abbott and/or AbbVie stock, Employee of: AbbVie, A. Robinson Shareholder of: May own Abbott and/or AbbVie stock, Employee of: AbbVie, R. Thakkar Shareholder of: May own Abbott and/or AbbVie stock, Employee of: AbbVie
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