The Journal of Practical Medicine >
Short term clinical efficacy and influencing factors of ustekinumab monoclonal antibody in the treatment of Crohn′s disease
Received date: 2023-12-14
Online published: 2024-04-08
Objective To analyze the short?term clinical efficacy and influencing factors of ustekinumab monoclonal antibody (UST) in the treatment of Crohn's disease (CD). Methods Retrospective cohort study was used to collect the clinical data of CD patients treated with UST in the 10th People's Hospital affiliated to Tongji University from December 2020 to October 2022. The main analysis is the short?term clinical efficacy and influencing factors of UST treatment for CD at weeks 8 and 16, And analyze the endoscopic response rate of some patients. Results A total of 91 CD patients who first used UST were included. The 8?week clinical response rate of UST treatment for CD was 61.5%, and the clinical response rate was 45%; The clinical response rate at 16 weeks was 71.4%, and the clinical response rate was 54.9%. 56 cases underwent endoscopic re?examination in our hospital, and the endoscopic response rate at 16 weeks was 41.1%. Univariate analysis showed that fistula (including anal fistula, personal history of anal fistula, and intestinal skin fistula) is associated with clinical remission in Crohn's disease patients at 8/16 weeks. Further multivariate COX regression analysis showed that the presence of a history of anal fistula surgery was an independent protective factor affecting clinical remission in CD patients treated with UST at 8 weeks (HR = 0.04,95% CI: 0.00 ~ 0.38; P = 0.005) and 16 weeks (HR = 0.04,95% CI: 0.01 ~ 0.34; P = 0.003) compared to those without fistula; Narrow lesions are an independent risk factor for 16 week clinical remission in CD patients compared to non?narrow and non?penetrating lesions (HR = 1.75, 95% CI: 1.08 ~ 2.84; P = 0.023). No patients were found to have stopped medication due to serious adverse reactions. Conclusions UST can improve the clinical remission and response of CD patients at 8/16 weeks, and has good short?term clinical efficacy. CD patients with a personal history of anal fistula are recommended to use UST monoclonal antibodies, while patients with stenotic lesions should be cautious in using UST monoclonal antibodies. Whether the patient has undergone surgical treatment in the past, as well as whether UST has been used on the first or non?first line, has no significant impact on clinical remission.
Rui WANG , Changqin LIU , Cui ZHANG , Qinglu YANG , Jiaolan YANG , Pengyun YIN , Xiaohui LI , Yongshun SUN , Zhanju LIU , Xiaomin. SUN . Short term clinical efficacy and influencing factors of ustekinumab monoclonal antibody in the treatment of Crohn′s disease[J]. The Journal of Practical Medicine, 2024 , 40(7) : 989 -995 . DOI: 10.3969/j.issn.1006-5725.2024.07.019
| 1 | BAUMGAR D C, SANDBORN W J. Crohn′s disease [J]. Lancet, 2012,380(9853):1590-1605. doi:10.1016/s0140-6736(12)60026-9 |
| 2 | WILSON J C, FURLANO R I, JICK S S, et al. Inflammatory bowel disease and the risk of autoimmune diseases [J]. J Crohns Colitis, 2016,10(2):186-193. doi:10.1093/ecco-jcc/jjv193 |
| 3 | XAVIER R J, PODOLSKY D K. Unravelling the pathogenesis of inflammatory bowel disease [J]. Nature, 2007, 448(7152):427-434. doi:10.1038/nature06005 |
| 4 | PEYRIN-BIROULET L, LOFTUS EV J R, COLOMBEL J F, et al. The natural history of adult Crohn′s disease in population-based cohorts [J]. Am J Gastroenterol, 2010, 105(2):289-297. doi:10.1038/ajg.2009.579 |
| 5 | NAKASE H, UCHINO M, SHINZAKI S, et al. Evidence-based clinical practice guidelines for inflammatory bowel disease 2020 [J]. J Gastroenterol, 2021,56(6):489-526. doi:10.1007/s00535-021-01784-1 |
| 6 | DEEPAK P, SANDBORN W J. Ustekinumab and Anti-Interleukin-23 Agents in Crohn′s Disease [J]. Gastroenterol Clin North Am, 2017, 46(3):603-626. doi:10.1016/j.gtc.2017.05.013 |
| 7 | PELUSO I, PALLONE F, MONTELEONE G, et al. Interleukin-12 and Th1 immune response in Crohn′s disease: pathogenetic relevance and therapeutic implication [J]. World J Gastroenterol, 2006,12(35):5606-5610. doi:10.3748/wjg.v12.i35.5606 |
| 8 | 中华医学会消化病学分会炎症性肠病学组.炎症性肠病诊断与治疗的共识意见(2018年,北京)[J].中华炎性肠病杂志,2018,2(3):173-190. |
| 9 | DEEPAK P, FLETCHER J G, FIDLER J L,et al. Radiological response is associated with better long-term outcomes and is a potential treatment target in patients with small bowel Crohn′s disease[J]. Am J Gastroenterol, 2016,111(7): 997-1006. doi:10.1038/ajg.2016.177 |
| 10 | CHAPARRO M, BASTON-REY I, ERNANDEZ-SALGADO E, et al. Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study [J]. Inflamm Bowel Dis, 2022, 28(11): 1725-1736. |
| 11 | NEWMAN K L, JEHNSON L A, STIDHAM R W, et al. Vedolizumab more likely to be discontinued than ustekinumab in anti-TNF-experienced patients with fistulizing Crohn's disease [J]. Therap Adv Gastroenterol, 2023, 16: 1098331230. doi:10.1177/17562848221148254 |
| 12 | YAO J, ZHANG H, SU T, et al. Ustekinumab Promotes Radiological Fistula Healing in Perianal Fistulizing Crohn's Disease: A Retrospective Real-World Analysis [J]. J Clin Med, 2023, 12(3): 939. doi:10.3390/jcm12030939 |
| 13 | CHATZIMICHAIL G, GüNTHER J, ST?NDER S, et al. Drug survival of secukinumab, ustekinumab, and certolizumab pegol in psoriasis: a 2-year, monocentric, retrospective study [J]. J Dermatolog Treat, 2022, 33(3): 1749-1753. doi:10.1080/09546634.2020.1854428 |
| 14 | BRESSLER B, JONES J, IN T, et al. Real-World Persistence of Ustekinumab in the Treatment of Inflammatory Bowel Disease [J]. Adv Ther, 2023, 40(10): 4421-4439. doi:10.1007/s12325-023-02611-0 |
| 15 | YAO J Y, ZHANG M, WANG W, et al. Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study [J]. BMC Gastroenterol, 2021, 21(1): 380. doi:10.1186/s12876-021-01946-8 |
| 16 | 陆君涛,徐锡涛,王天蓉,等. 乌司奴单克隆抗体治疗克罗恩病的疗效及安全性分析[J]. 中华炎性肠病杂志, 2023,7(1):37-42. doi:10.3760/cma.j.cn101480-20220613-00087 |
| 17 | YAO L, ZHU X, SHAO B, et al. Reasons and Factors Contributing to Chinese Patients' Preference for Ustekinumab in Crohn's Disease: A Multicenter Cross-Sectional Study[J]. Front Pharmacol, 2021, 12: 736149. doi:10.3389/fphar.2021.736149 |
| 18 | STRAATMIJER T, BIEMANS V, MOES D, et al. Ustekinumab Trough Concentrations Are Associated with Biochemical Outcomes in Patients with Crohn's Disease [J]. Dig Dis Sci, 2023, 68(6): 2647-2657. doi:10.1007/s10620-023-07822-7 |
| 19 | JOHNSON A M, BARSKY M, AHMED W, et al. The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium [J]. Am J Gastroenterol, 2023, 118(2): 317-328. |
| 20 | SHIGA H, TARASAWA K, MOROI R, et al. Long-term effectiveness of ustekinumab comparable to antitumor necrosis factor agents in patients with Crohn's disease [J]. J Gastroenterol Hepatol, 2022, 37(11): 2105-2112. doi:10.1111/jgh.15992 |
| 21 | TURSOI A, MOCCI G, CUOMO A, et al. Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn's disease: results from a large Italian cohort study [J]. Eur Rev Med Pharmacol Sci, 2021, 25(4): 2099-2108. |
| 22 | PARRA R S, CHEBLI J, QUEIROZ N, et al. Long-term effectiveness and safety of ustekinumab in bio-na?ve and bio-experienced anti-tumor necrosis factor patients with Crohn's disease: a real-world multicenter Brazilian study [J]. BMC Gastroenterol, 2022, 22(1): 199. doi:10.1186/s12876-022-02280-3 |
| 23 | ALBSHESH A, BANNON L, SHARAR F T, et al. Comparison of Short- and Long-Term Effectiveness between Anti-TNF and Ustekinumab after Vedolizumab Failure as First-Line Therapy in Crohn's Disease: A Multi-Center Retrospective Cohort Study [J]. J Clin Med, 2023, 12(7): 2503. doi:10.3390/jcm12072503 |
| 24 | BOKEMEYER B, PLACHAT-DANIELZIK S, DI GIUSEPPE R, et al. Real-world Comparative Effectiveness of Ustekinumab vs Anti-TNF in Crohn's Disease With Propensity Score Adjustment: Induction Phase Results From the Prospective, Observational RUN-CD Study [J]. Inflamm Bowel Dis, 2023, 29(11): 1741-1750. doi:10.1093/ibd/izac271 |
| 25 | ZHOU H, WANG F, WAN J, et al. Systematic Review and Meta-Analysis of Observational Studies on the Effectiveness and Safety of Ustekinumab among Patients with Inflammatory Bowel Disease in Eastern and Western Countries [J]. J Clin Med, 2023,12(5):1894. doi:10.3390/jcm12051894 |
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