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Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis.
- Source :
-
Gastroenterology [Gastroenterology] 2014 Jan; Vol. 146 (1), pp. 85-95; quiz e14-5. Date of Electronic Publication: 2013 Jun 02. - Publication Year :
- 2014
-
Abstract
- Background & Aims: Little is known about the efficacy of golimumab, a fully human monoclonal antibody to tumor necrosis factor (TNF) -α, for treatment of ulcerative colitis (UC). We evaluated subcutaneous golimumab induction therapy in TNF-α antagonist-naïve patients with moderate-to-severe UC despite conventional treatment.<br />Methods: We integrated double-blind phase 2 dose-finding and phase 3 dose-confirmation trials in a study of 1064 adults with UC (Mayo score: 6-12; endoscopic subscore ≥ 2; 774 patients in phase 3). Patients were randomly assigned to groups given golimumab doses of 100 mg and then 50 mg (phase 2 only), 200 mg and then 100 mg, or 400 mg and then 200 mg, 2 weeks apart. The phase 3 primary end point was week-6 clinical response. Secondary end points included week-6 clinical remission, mucosal healing, and Inflammatory Bowel Disease Questionnaire (IBDQ) score change.<br />Results: In phase 2, median changes from baseline in the Mayo score were -1.0, -3.0, -2.0, and -3.0, in the groups given placebo, 100 mg/50 mg, 200/100 mg, and 400/200 mg golimumab, respectively. In phase 3, rates of clinical response at week 6 were 51.0% and 54.9% among patients given 200 mg/100 mg and 400 mg/200 mg golimumab, respectively, vs 30.3% among those given placebo (both, P ≤ .0001). Rates of clinical remission and mucosal healing and mean changes in IBDQ scores were significantly greater in both golimumab groups vs the placebo group (P ≤ .0014, all comparisons). Rates of serious adverse events were 6.1% and 3.0%, and rates of serious infection were 1.8% and 0.5%, in the placebo and golimumab groups, respectively. One patient in the 400 mg/200 mg group died as a result of surgical complications of an ischiorectal abscess.<br />Conclusions: Treatment with subcutaneous golimumab induces clinical response, remission, and mucosal healing, and increases quality of life in larger percentages of patients with active UC than placebo. ClinicalTrials.gov Number: NCT00487539.<br /> (Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adrenal Cortex Hormones therapeutic use
Adult
Aminosalicylic Acids therapeutic use
Azathioprine therapeutic use
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Injections, Subcutaneous
Male
Mercaptopurine therapeutic use
Methotrexate therapeutic use
Middle Aged
Quality of Life
Remission Induction methods
Treatment Outcome
Anti-Inflammatory Agents therapeutic use
Antibodies, Monoclonal therapeutic use
Colitis, Ulcerative drug therapy
Immunosuppressive Agents therapeutic use
Tumor Necrosis Factor-alpha antagonists & inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0012
- Volume :
- 146
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 23735746
- Full Text :
- https://doi.org/10.1053/j.gastro.2013.05.048