Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study)

Journal of Gastroenterology

Volumn 52, Issue 10, 2017, Pages 1101-1111

  Hibi, Toshifumi ^a   Imai, Yuya ^b   Senoo, Asako ^b   Ohta, Kentaro ^b   Ukyo, Yoshifumi ^b  

^a KITASATO UNIVERSITY   (Japan)

^b Janssen Pharmaceutical KK   (Japan)

Author keywords

Anti TNF antibody; Golimumab; Japanese patients; Maintenance therapy; PURSUIT; Ulcerative colitis

Indexed keywords

AZATHIOPRINE; C REACTIVE PROTEIN; CALGRANULIN; CORTICOSTEROID; GOLIMUMAB; LACTOFERRIN; MERCAPTOPURINE; MESALAZINE; PLACEBO; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR;

ADULT; AORTIC ARCH SYNDROME; ARTICLE; BRAIN INFARCTION; COLITIS; CONJUNCTIVITIS; CONTROLLED STUDY; CORTICOSTEROID THERAPY; CYTOMEGALOVIRUS INFECTION; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG USE; DRUG WITHDRAWAL; ERYTHEMA; FEMALE; HAND FRACTURE; HEALING; HERPETIC STOMATITIS; HUMAN; IMMUNOGENICITY; INCIDENCE; INFLUENZA; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; JAPANESE (PEOPLE); JOINT DISLOCATION; LYMPHOCYTE COUNT; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PATIENT-REPORTED OUTCOME; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHINOPHARYNGITIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; ULCERATIVE COLITIS; ANTAGONISTS AND INHIBITORS; ASIAN CONTINENTAL ANCESTRY GROUP; CLINICAL TRIAL; MIDDLE AGED; MULTICENTER STUDY; PATHOPHYSIOLOGY; PROCEDURES; SEVERITY OF ILLNESS INDEX; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADULT; ANTIBODIES, MONOCLONAL; ASIAN CONTINENTAL ANCESTRY GROUP; COLITIS, ULCERATIVE; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; REMISSION INDUCTION; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 85015738995     PISSN: 09441174     EISSN: 14355922     Source Type: Journal    
DOI: 10.1007/s00535-017-1326-1     Document Type: Article

References (19)

1. Ordas I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet. 2012;380:1606–19.
2. Cosnes J, Gower-Rousseau C, Seksik P, et al. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011;140:1785–94.
3. Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences. Gastroenterology. 2004;126:1504–17.
4. Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015;12:205–17.
5. Thia KT, Loftus EV Jr, Sandborn WJ, et al. An update on the epidemiology of inflammatory bowel disease in Asia. Am J Gastroenterol. 2008;103:3167–82.
6. Hanauer SB, Present DH. The state of the art in the management of inflammatory bowel disease. Rev Gastroenterol Disord. 2003;3:81–92.
7. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–76.
8. Sands BE, Kaplan GG. The role of TNFalpha in ulcerative colitis. J Clin Pharmacol. 2007;47:930–41.
9. Sandborn WJ, Feagan BG, Marano C. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:85–95 quiz e14-5.
10. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(96–109):e1.
11. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. N Engl J Med. 1987;317:1625–9.
12. Irvine EJ, Feagan B, Rochon J. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Gastroenterology. 1994;106:287–96.
13. Higgins PDR, Schwartz M, Mapili J, et al. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005;54:782–8.
14. Hibi T, Imai Y, Ota T. Efficacy and safety of golimumab subcutaneous administration in Japanese patients with moderately to severely active ulcerative colitis (PURSUIT-J). In: Poster presented at 4th annual meeting of Asian Organization for Crohn’s & Colitis, Kyoto, Japan. 7–9 July 2016. Poster no. PO-063.
15. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014;2:161–8.
16. Löwenberg M, de Boer NKH, Hoentjen F. Golimumab for the treatment of ulcerative colitis. Clin Experimental Gastroenterology. 2014;7:53–9.
17. Ardizzone S, Maconi G, Russo A, et al. Randomised controlled trial of azathioprine and 5-aminosalicylic acid for treatment of steroid dependent ulcerative colitis. Gut. 2006;55:47–53.
18. Panes J, Su C, Bushmakin AG, et al. Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. BMC Gastroenterol. 2015;15:14.
19. Mosli MH, Zou G, Garg SK, et al. C-reactive protein, fecal calprotectin, and stool lactoferrin for detection of endoscopic activity in symptomatic inflammatory bowel disease patients: a systematic review and meta-analysis. Am J Gastroenterol. 2015;110:802–19.