PMID- 36645145 OWN - NLM STAT- MEDLINE DCOM- 20230227 LR - 20230509 IS - 1365-2036 (Electronic) IS - 0269-2813 (Linking) VI - 57 IP - 6 DP - 2023 Mar TI - Meta-analysis: Real-world effectiveness and safety of ustekinumab in patients with ulcerative colitis. PG - 610-619 LID - 10.1111/apt.17386 [doi] AB - BACKGROUND: Evidence on real-world outcomes of ustekinumab for ulcerative colitis (UC) patients is needed. AIMS: To summarise evidence on the real-world outcomes of ustekinumab for UC and conduct a meta-analysis of effectiveness and safety data. METHODS: A systematic search was conducted through September 2022 in electronic databases for observational studies evaluating ustekinumab for UC. A random-effects meta-analysis model was used to calculate the pooled effect sizes (percentages or incidence rates [IRs]) of effectiveness and safety outcomes. RESULTS: In all, 19 studies were included with 3786 patients. More than 92% of patients were previously treated with any biologic, 61.1% with both anti-TNF and vedolizumab and 16.4% with any biologic and tofacitinib. Clinical remission was achieved in 45.4% at week 8 (95% CI: 30.1%-60.6%), 43.8% (38.4%-49.2%) at weeks 12-16, 44.6% (35.9%-53.3%) at month 6, and 50.6% (36.3%-64.8%) at month 12. Response was achieved in 61.2%, 59.4%, 65.2% and 76.8% at weeks 8, 12-16, month 6 and 12, respectively. CS-free remission was achieved in 18.7%, 36.8%, 34.5% and 39% at weeks 8, 12-16, month 6 and 12, respectively. Overall, 58.2% of patients had endoscopic improvement at month 12. Almost 30% of the patients needed dose escalation, which was effective in 40% of these patients. The IRs of colectomy, adverse events (AEs), serious AEs and serious infections were 4.8, 7.9, 0.8 and 0.3 per 100 patient-years, respectively. CONCLUSIONS: This meta-analysis confirms the effectiveness and safety of ustekinumab in a highly treatment-refractory population of UC patients. CI - (c) 2023 John Wiley & Sons Ltd. FAU - Taxonera, Carlos AU - Taxonera C AUID- ORCID: 0000-0001-9166-7350 AD - Inflammatory Bowel Disease Unit, Gastroenterology Department, Hospital Clinico San Carlos and Instituto de Investigacion del Hospital Clinico San Carlos [IdISSC], Madrid, Spain. FAU - Olivares, David AU - Olivares D AUID- ORCID: 0000-0003-3506-7355 AD - Inflammatory Bowel Disease Unit, Gastroenterology Department, Hospital Clinico San Carlos and Instituto de Investigacion del Hospital Clinico San Carlos [IdISSC], Madrid, Spain. FAU - Lopez-Garcia, Olga N AU - Lopez-Garcia ON AUID- ORCID: 0000-0002-7397-0177 AD - Gastroenterology Department, Hospital Clinico San Carlos, Madrid, Spain. FAU - Alba, Cristina AU - Alba C AD - Inflammatory Bowel Disease Unit, Gastroenterology Department, Hospital Clinico San Carlos and Instituto de Investigacion del Hospital Clinico San Carlos [IdISSC], Madrid, Spain. LA - eng PT - Journal Article PT - Meta-Analysis PT - Review DEP - 20230116 PL - England TA - Aliment Pharmacol Ther JT - Alimentary pharmacology & therapeutics JID - 8707234 RN - FU77B4U5Z0 (Ustekinumab) RN - 0 (Tumor Necrosis Factor Inhibitors) RN - 0 (Biological Products) SB - IM MH - Humans MH - *Colitis, Ulcerative/drug therapy MH - Ustekinumab/therapeutic use MH - Tumor Necrosis Factor Inhibitors/therapeutic use MH - Colectomy MH - *Biological Products/therapeutic use MH - Treatment Outcome MH - Remission Induction OTO - NOTNLM OT - effectiveness OT - meta-analysis OT - real world OT - safety OT - systematic review OT - ulcerative colitis OT - ustekinumab EDAT- 2023/01/17 06:00 MHDA- 2023/03/03 06:00 CRDT- 2023/01/16 07:03 PHST- 2022/11/22 00:00 [revised] PHST- 2022/10/24 00:00 [received] PHST- 2022/12/29 00:00 [accepted] PHST- 2023/01/17 06:00 [pubmed] PHST- 2023/03/03 06:00 [medline] PHST- 2023/01/16 07:03 [entrez] AID - 10.1111/apt.17386 [doi] PST - ppublish SO - Aliment Pharmacol Ther. 2023 Mar;57(6):610-619. doi: 10.1111/apt.17386. Epub 2023 Jan 16.