USTEKINUMAB EFFECTIVENESS AND SUSTAINABILITY IN ULCERATIVE COLITIS AND CROHN’S DISEASE

Öz

Objective: This study aimed to investigate the effectiveness, sustainability, and side effects of ustekinumab in patients with ulcerative colitis (UC) and Crohn’s disease (CD). Material and Methods: The data of 48 inflammatory bowel disease patients who were unresponsive to previous treatment and were followed up at a tertiary centre were retrospectively investigated. Demographic features, characteristics of bowel diseases, treatment experiences, laboratory and endoscopic features, and disease scores [Crohn’s Disease Activity Index (CDAI) and Simple Clinical Colitis Activity Index (SCCAI)] were analysed. Results: Of the total 48 patients, 35 (73%) were CD and 26 (54.2%) were women. The mean age of the patients was 42.1±13.3 years, and the mean age of disease was 136.8±92 months. There was previous use of biological agents in 100% of both UC and CD. The most common reason for switching to ustekinumab in patients was a lack of response to previous biologics (90%). The mean duration of use of ustekinumab was 17.1±8 months. At the end of the followup, 71% of the CD patients had CDAI<150 and were in complete clinical remission, and 53.8% of the UC patients had SCCAI<5 and were in complete clinical remission. Control endoscopy was performed for 13 UCs, and 6 (46.2%) had endoscopic remission. Control endoscopy was performed for 5 CDs, and 3 (60%) had endoscopic remission. Conclusion: Ustekinumab is an effective treatment method in achieving clinical remission in CD and UC resistant to previous treatments in the followup.

Anahtar Kelimeler

• Crohn’s disease
• ulcerative colitis
• ustekinumab

USTEKİNUMAB’IN ÜLSERATİF KOLİT VE CROHN HASTALIĞI’NDA ETKİNLİĞİ VE SÜRDÜRÜLEBİLİRLİĞİ

Öz

Amaç: Bu çalışmanın amacı, ülseratif kolit (ÜK) ve Crohn hastalığı (CH) olan hastalarda ustekinumabın etkinliğini, sürdürülebilirliğini ve yan etkilerini araştırmaktır. Gereç ve Yöntemler: Önceki tedavilere yanıt vermeyen ve tersiyer bir merkezde takip edilen 48 inflamatuar barsak hastasının veri leri retrospektif olarak incelendi. Hastaların demografik özellikleri, barsak hastalıklarının özellikleri, tedavi deneyimleri, laboratuvar ve endoskopik özellikleri ve hastalık skorları Crohn Hastalığı Ak tivite İndeksi (CHAI) ve Basit Klinik Kolit Aktivite indeksi (BKKAİ) incelendi. Bulgular: Toplam 48 hastanın 35′i (%73) CH, 26′sı (%54,2) kadındı. Hastaların yaş ortalaması 42,1±13,3 yıl, hastalık yaşı ortalaması 136,8±92 aydı. Hem ÜK hem de CH’nın %100′ünde daha önce biyolojik ajan kullanımı vardı. Hastalarda ustekinumaba geçişin en yaygın nedeni önceki biyolojik ilaçlara yanıtsızlıktı (%90). Ustekinumabın ortalama kullanım süresi 17,1±8 aydı. Takip sonunda CH’larının %71′inde CDAI<150 idi ve tam klinik remisyondaydı. ÜK hastalarının %53,8′inde SCCAI<5 idi ve tam klinik remisyondaydı. 13 ÜK hastasına kontrol kolonoskopi yapıldı ve 6′sında (%46.2) endoskopik remisyon görüldü. 5 CH’na kontrol kolonoskopi yapıldı ve 3 (%60) hastada endoskopik remisyon görüldü. Sonuç: Ustekinumab, daha önceki tedavilere dirençli CH ve ÜK’de takipte klinik remisyon sağlanmasında etkili bir tedavi yöntemidir.

Anahtar Kelimeler

• Crohn hastalığı
• ülseratif kolit
• ustekinumab

Kaynakça

1. Cai Z, Wang S, Li J. Treatment of Inflammatory Bowel disease: A comprehensive review. Front Med (Lausanne) 2021;8:765474. google scholar
2. Spekhorst LM, Visschedijk MC, Alberts R, Festen EA, van der Wouden EJ, Dijkstra G, et al. Dutch initiative on Crohn and colitis. Performance of the Montreal classification for inflammatory bowel diseases. World J Gastroenterol 2014;20(41):15374-81. google scholar
3. Gajendran M, Loganathan P, Catinella AP, Hashash JG. A comprehensive review and update on Crohn's disease. Dis Mon 2018;64(2):20-57. google scholar
4. Marín-Jiménez I, Nos P, Domènech E, Riestra S, Gisbert JP, Calvet X, et al. Diagnostic performance of the simple clinical colitis activity index self- administered online at home by patients with ulcerative colitis: CRONICA-UC Study. Am J Gastroenterol 2016;111(2):261-8. google scholar
5. Peraza J, Kaper ME, Bargas A, Kim I, Agrawal M, Larsen L et al. A simple endoscopic score for Crohn's disease (SES-CD) ≥ 7 predicts disease progression. Aliment Pharmacol Ther 2025;61(6):1011-8. google scholar
6. Sharara AI, Malaeb M, Lenfant M, Ferrante M. Assessment of endoscopic disease activity in ulcerative colitis: Is simplicity the ultimate sophistication? Inflamm Intest Dis 2021;7(1):7-12. google scholar
7. Bruner LP, White AM, Proksell S. Inflammatory Bowel disease. Prim Care 2023;50(3):411-27. google scholar
8. Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019;68(Suppl 3):s1-106. google scholar

9. Bretto E, Ribaldone DG, Caviglia GP, Saracco GM, Bugianesi E, Frara S. Inflammatory Bowel Disease: Emerging therapies and future treatment strategies. Biomedicines 2023;11(8):2249. google scholar
10. Jairath V, Acosta Felquer ML, Cho RJ. IL-23 inhibition for chronic inflammatory disease. Lancet 2024;404(10463):1679-92. google scholar
11. Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2019;381(13):1201-14. google scholar
12. Sandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, et al. Five-Year Efficacy and safety of ustekinumab treatment in Crohn's disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol 2022;20(3):578-90. google scholar
13. Engel T, Yung DE, Ma C, Pariente B, Wils P, Eliakim R, et al. Effectiveness and safety of ustekinumab for Crohn's disease; Systematic review and pooled analysis of real-world evidence. Dig Liver Dis 2019;51(9):1232-40. google scholar
14. Harris KA, Horst S, Gadani A, Nohl A, Annis K, Duley C, et al. Patients with refractory Crohn's disease successfully treated with ustekinumab. Inflamm Bowel Dis 2016;22(2):397-401. google scholar
15. Peyrin-Biroulet L, Vermeire S, D'Haens G, Panés J, Dignass A, Magro F, et al. Clinical trial: Clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease: Results from the long-term extension period of STARDUST. Aliment Pharmacol Ther 2024(2):175-85. google scholar
16. Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, et al. Efficacy of ustekinumab for inducing endoscopic healing in patients with Crohn’s disease. Gastroenterology 2018;155(4):1045-58. google scholar
17. Yamamoto Y, Takeuchi I, Shimizu H, Fujikawa H, Toda M, Miyata E, et al. Long-term clinical and endoscopic outcomes of ustekinumab in pediatric Crohn's disease with anti-tumor necrosis factor failure. J Gastroenterol Hepatol 2025;40(1):123-32. google scholar
18. Ghosh S, Feagan BG, Ott E, Gasink C, Godwin B, Marano C, et al. Safety of ustekinumab in inflammatory Bowel disease: Pooled safety analysis through 5 years in Crohn's disease and 4 years in ulcerative colitis. J Crohns Colitis 2024;18(7):1091-101. google scholar
19. Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, et al. Safety of ustekinumab in inflammatory Bowel disease: Pooled safety analysis of results from phase 2/3 studies. Inflamm Bowel Dis 2021;27(7):994-1007. google scholar
20. Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, et al. Ustekinumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2016;375(20):1946-60. google scholar
21. Johnson AM, Barsky M, Ahmed W, Zullow S, Galati J, Jairath V, et al. The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium. Am J Gastroenterol 2023;118(2):317-28. google scholar
22. Hasan B, Tandon KS, Miret R, Khan S, Riaz A, Gonzalez A, et al. Ustekinumab does not increase risk of new or recurrent cancer in inflammatory bowel disease patients with prior malignancy. J Gastroenterol Hepatol 2022;37(6):1016-21. google scholar