Safety and tolerability of spesolimab in patients with ulcerative colitis

References

• Feuerstein JD, Moss AC, Farraye FA. Ulcerative colitis. Mayo Clin Proc. 2019;94(7):1357–1373.
   PubMed Web of Science ®Google Scholar
• Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114(3):384–413.
   PubMed Web of Science ®Google Scholar
• Segal JP, LeBlanc JF, Hart AL. Ulcerative colitis: an update. Clin Med (Lond). 2021;21(2):135–139.
   PubMed Web of Science ®Google Scholar
• Magro F, Gionchetti P, and Eliakim R, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders. J Crohns Colitis. 2017;11(6):649–670.
   PubMed Web of Science ®Google Scholar
• Kühn F, and Klar E. Surgical principles in the treatment of ulcerative colitis. Viszeralmedizin. 2015;31(4):246–250.
   PubMedGoogle Scholar
• Yarlas A, Rubin DT, Panes J, et al. Burden of ulcerative colitis on functioning and well-being: a systematic literature review of the SF-36(R) health survey. J Crohns Colitis. 2018;12(5):600–609.
   PubMed Web of Science ®Google Scholar
• Rapport F, Clement C, Seagrove AC, et al. Patient views about the impact of ulcerative colitis and its management with drug treatment and surgery: a nested qualitative study within the CONSTRUCT trial. BMC Gastroenterol. 2019;19(1):166.
   PubMed Web of Science ®Google Scholar
• Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting therapeutic targets in inflammatory bowel disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol. 2015;110(9):1324–1338.
   PubMed Web of Science ®Google Scholar
• Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management. J Crohns Colitis. 2017;11(7):769–784.
   PubMed Web of Science ®Google Scholar
• Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology. 2020;158(5):1450–1461.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Feagan BG, D’Haens G, et al. Ozanimod as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2021;385(14):1280–1291.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723–1736.
   PubMed Web of Science ®Google Scholar
• Baker DM, Folan AM, Lee MJ, et al. A systematic review and meta-analysis of outcomes after elective surgery for ulcerative colitis. Colorectal Dis. 2021;23(1):18–33.
   PubMed Web of Science ®Google Scholar
• O’Hagan P, Limdi J, Akbar A, et al. Ulcerative colitis: understanding the impact of ulcerative colitis on everyday life and exploring the unmet needs of patients. Curr Med Res Opin. 2021;37(11):1901–1911.
   PubMed Web of Science ®Google Scholar
• Le Berre C, Peyrin-Biroulet L, SPIRIT -IOIBD study group. group S-Is. Selecting end points for disease-modification trials in inflammatory bowel disease: the SPIRIT Consensus from the IOIBD. Gastroenterology. 2021;160(5):1452–1460.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Guideline on the development of new medicinal products for the treatment of Crohn’s disease. CPMP/EWP/2284/99 Rev. 2; 2018 [cited 2022 May 30]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-crohns-disease-revision-2_en.pdf.
   Google Scholar
• Herrlinger KR, and Stange EF. Twenty-five years of biologicals in IBD: what’s all the hype about? J Intern Med. 2021;290(4):806–825.
   PubMed Web of Science ®Google Scholar
• Loftus EV Jr., Feagan BG, Panaccione R, et al. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020;52(8):1353–1365.
   PubMed Web of Science ®Google Scholar
• Shimodaira Y, Watanabe K, Iijima K. Clinical course of ulcerative colitis associated with an age at diagnosis: a recent Japanese database survey. Tohoku J Exp Med. 2021;255(1):33–39.
   PubMed Web of Science ®Google Scholar
• Nishida A, Hidaka K, Kanda T, et al. Increased expression of interleukin-36, a member of the interleukin-1 cytokine family, in inflammatory bowel disease. Inflamm Bowel Dis. 2016;22(2):303–314.
   PubMed Web of Science ®Google Scholar
• Neufert C, Neurath MF, and Atreya R. Rationale for IL-36 receptor antibodies in ulcerative colitis. Expert Opin Biol Ther. 2020;20(4):339–342.
   PubMed Web of Science ®Google Scholar
• Mrowietz U, Burden AD, and Pinter A, et al. Spesolimab, an anti-interleukin-36 receptor antibody, in patients with palmoplantar pustulosis: results of a Phase IIa, multicenter, double-blind, randomized, placebo-controlled pilot study. Dermatol Ther (Heidelb). 2021;11(2):571–585.
   PubMed Web of Science ®Google Scholar
• Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15(9):907–919.
   PubMed Web of Science ®Google Scholar
• Bachelez H, Choon SE, and Marrakchi S, et al. Inhibition of the interleukin-36 pathway for the treatment of generalized pustular psoriasis. N Engl J Med. 2019;380(10):981–983.
   PubMed Web of Science ®Google Scholar
• Russell SE, Horan RM, and Stefanska AM, et al., IL-36α expression is elevated in ulcerative colitis and promotes colonic inflammation. Mucosal Immunol. 2016;9(5):1193–1204.
   PubMed Web of Science ®Google Scholar
• Scheibe K, Kersten C, and Schmied A, et al. Inhibiting interleukin 36 receptor signaling reduces fibrosis in mice with chronic intestinal inflammation. Gastroenterology. 2019;156(4): 1082–97.e11.
   PubMed Web of Science ®Google Scholar
• Ganesan R, Raymond EL, Mennerich D, et al. Generation and functional characterization of anti-human and anti-mouse IL-36R antagonist monoclonal antibodies. MAbs. 2017;9(7):1143–1154.
   PubMed Web of Science ®Google Scholar
• Bachelez H, Choon SE, and Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;85(26):2431–2440.
   Google Scholar
• ClinicalTrials.gov. NCT03482635. BI655130 (spesolimab) induction treatment in patients with moderate-to-severe ulcerative colitis. [cited 2021 Dec 16] Available from: https://www.clinicaltrials.gov/ct2/show/NCT03482635.
   Google Scholar
• ClinicalTrials.gov. NCT03123120. A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. [cited 2021 Dec 16] Available from: https://www.clinicaltrials.gov/ct2/show/NCT03123120.
   Google Scholar
• ClinicalTrials.gov. NCT03100864. This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. [cited 2021 Dec 16] Available from: https://www.clinicaltrials.gov/ct2/show/NCT03100864.
   Google Scholar
• Woodworth T, Furst DE, Alten R, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol. 2007;34(6):1401–1414.
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov. NCT03648541. BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis. [cited 2022 May 30]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03648541.
   Google Scholar