Peficitinib, an Oral Janus Kinase Inhibitor, in Moderate-to-severe Ulcerative Colitis: Results from a randomised, phase 2 study

Journal of Crohn's and Colitis

Volumn 12, Issue 10, 2018, Pages 1158-1169

  Sands, Bruce E ^g   Sandborn, William J ^a   Feagan, Brian G ^b   Lichtenstein, Gary R ^c   Zhang, Hongyan ^d   Strauss, Richard ^d   Szapary, Philippe ^d   Johanns, Jewel ^d   Panes, Julian ^e   Vermeire, Severine ^f   O'Brien, Christopher D ^d   Yang, Zijiang ^d   Bertelsen, Kirk ^d   Marano, Colleen ^d  

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b ROBARTS RESEARCH INSTITUTE   (Canada)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^e INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^f UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^g MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Inflammatory bowel disease; JAK; Placebo controlled

Indexed keywords

BIOLOGICAL MARKER; BUDESONIDE; C REACTIVE PROTEIN; CALGRANULIN; CORTICOSTEROID; CREATINE KINASE; CYCLOSPORINE; JNJ 54781532; LACTOFERRIN; MERCAPTOPURINE; MESALAZINE; PEFICITINIB; PLACEBO; RAPAMYCIN; TACROLIMUS; ADAMANTANE; JANUS KINASE INHIBITOR; NICOTINAMIDE;

ADULT; ANEMIA; ARTICLE; BASAL CELL CARCINOMA; CLOSTRIDIUM DIFFICILE INFECTION; CONTROLLED STUDY; DIGESTIVE SYSTEM DISEASE ASSESSMENT; DISEASE DURATION; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHINOPHARYNGITIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; ULCERATIVE COLITIS; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DRUG EFFECT; DRUG MONITORING; IMMUNOLOGY; INTESTINE MUCOSA; ORAL DRUG ADMINISTRATION; PATHOLOGY; PROCEDURES; PSYCHOLOGY; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX;

ADAMANTANE; ADMINISTRATION, ORAL; ADULT; BIOMARKERS; C-REACTIVE PROTEIN; COLITIS, ULCERATIVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; FEMALE; HUMANS; INTESTINAL MUCOSA; JANUS KINASE INHIBITORS; MALE; MIDDLE AGED; NIACINAMIDE; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 85056376862     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1093/ecco-jcc/jjy085     Document Type: Article

References (23)

1. Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences. Gastroenterology 2004;126:1504-17.
2. Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012;142:46-54.e42; quiz e30.
3. Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010;105:501-23; quiz 524.
4. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 2011;60:780-7.
5. Travis SPL, Stange EF, Lémann M, et al.; European Crohn's and Colitis Organisation [ECCO]. European evidence-based consensus on the management of ulcerative colitis: current management. J Crohns Colitis 2008;2:24-62.
6. Lichtenstein GR, Abreu MT, Cohen R, Tremaine W; American Gastroenterological Association. American Gastroenterological Association Institute medical position statement on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006;130:935-9.
7. Roda G, Jharap B, Neeraj N, Colombel JF. Loss of response to anti-TNFs: definition, epidemiology, and management. Clin Transl Gastroenterol 2016;7:e135.
8. Olivera P, Danese S, Peyrin-Biroulet L. Next generation of small molecules in inflammatory bowel disease. Gut 2017;66:199-209.
9. Boland BS, Sandborn WJ, Chang JT. Update on Janus kinase antagonists in inflammatory bowel disease. Gastroenterol Clin North Am 2014;43:603-17.
10. Vermeire S, Schreiber S, Petryka R, et al. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib [the FITZROY study]: results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet 2017;389:266-75.
11. Strober W, Fuss IJ. Proinflammatory cytokines in the pathogenesis of inflammatory bowel diseases. Gastroenterology 2011;140:1756-67.
12. Mitchell TJ, John S. Signal transducer and activator of transcription [STAT] signalling and T-cell lymphomas. Immunology 2005;114:301-12.
13. Kühbacher T, Gionchetti P, Hampe J, et al. Activation of signal-transducer and activator of transcription 1 [STAT1] in pouchitis. Clin Exp Immunol 2001;123:395-401.
14. Sandborn WJ, Su C, Sands BE, et al.; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2017;376:1723-36.
15. Takeuchi T, Tanaka Y, Iwasaki M, Ishikura H, Saeki S, Kaneko Y. Efficacy and safety of the oral Janus kinase inhibitor peficitinib [ASP015K] monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study. Ann Rheum Dis 2016;75:1057-64.
16. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987;317:1625-9.
17. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975;31:103-15.
18. Bretz F, Pinheiro JC, Branson M. Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics 2005;61:738-48.
19. Sandborn WJ, Ghosh S, Panes J, et al.; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med 2012;367:616-24.
20. Ito M, Yamazaki S, Yamagami K, et al. A novel JAK inhibitor, peficitinib, demonstrates potent efficacy in a rat adjuvant-induced arthritis model. J Pharmacol Sci 2017;133:25-33.
21. Jostins L, Ripke S, Weersma RK, et al.; International IBD Genetics Consortium [IIBDGC]. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature 2012;491:119-24.
22. Selmaj K, Li DK, Hartung HP, et al. Siponimod for patients with relapsing-remitting multiple sclerosis [BOLD]: an adaptive, dose-ranging, randomised, phase 2 study. Lancet Neurol 2013;12:756-67.
23. So A, De Meulemeester M, Pikhlak A, et al. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: results of a multi-center, phase II, dose-ranging study. Arthritis Rheum 2010;62:3064-76.