Patient-reported continuous clinical response to golimumab in adults with moderately to severely active ulcerative colitis

التفاصيل البيبلوغرافية
العنوان: Patient-reported continuous clinical response to golimumab in adults with moderately to severely active ulcerative colitis
المؤلفون: Marc, Ferrante, Anja, Schirbel, Marieke J, Pierik, Thomas, Haas, Mathurin, Flamant, Ahmed, Khalifa, George, Philip, Freddy, Cornillie, Alan G, Meehan, Marinella, Govoni
المساهمون: Interne Geneeskunde, MUMC+: MA Maag Darm Lever (9), RS: NUTRIM - R2 - Liver and digestive health
المصدر: European Journal of Gastroenterology & Hepatology, 34(6), 646-654. LIPPINCOTT WILLIAMS & WILKINS
بيانات النشر: LIPPINCOTT WILLIAMS & WILKINS, 2022.
سنة النشر: 2022
مصطلحات موضوعية: Adult, moderate-to, Hepatology, Mayo score, Remission Induction, Gastroenterology, Antibodies, Monoclonal, REMISSION, severe ulcerative colitis, Severity of Illness Index, Treatment Outcome, Humans, Colitis, Ulcerative, Patient Reported Outcome Measures, Prospective Studies, golimumab, Gastrointestinal Hemorrhage
الوصف: BACKGROUND: In PURSUIT, golimumab (GLM) was efficacious in patients with moderate-to-severe ulcerative colitis (UC). We assessed whether remote monitoring of combined patient-reported Mayo stool frequency and rectal bleeding scores is an effective real-world outcome measure for assessing maintenance of GLM-induced clinical response.METHODS: This was a 54-week prospective, observational cohort study conducted at 43 European outpatient clinics in adults with moderate-to-severe UC who were biologic naïve or had received a maximum of one other biological therapy. Patients were treated according to European GLM UC label/local practice. Clinical response (based on partial or full Mayo score) was assessed at week 6, 10, or 14 of induction, depending on local practice. Investigators remotely monitored scores every 4 weeks. The primary endpoint was the proportion of induction responders in patient-reported continuous clinical response (pCCR) at week 54, defined as absence of UC flare based on combined patient-reported Mayo stool frequency and rectal bleeding scores every 4 weeks and full or partial Mayo score. A key secondary endpoint was the proportion of induction responders in clinical remission at week 54.RESULTS: Among 109 patients, 37 (34.0%) received at least two GLM induction doses and completed induction in clinical response (induction responders). At week 54, 15/37 (40.5%) induction responders were in pCCR, and 21/37 (56.8%) were in clinical remission.CONCLUSION: In daily clinical practice, regular remote monitoring of combined patient-reported Mayo stool frequency and rectal bleeding scores appears to be a meaningful real-world outcome measure for monitoring maintenance of GLM-induced clinical response in UC.
اللغة: English
تدمد: 1473-5687
0954-691X
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b8880c36ca9b9e14bcf4eccfa8c79404
https://doi.org/10.1097/MEG.0000000000002374
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....b8880c36ca9b9e14bcf4eccfa8c79404
قاعدة البيانات: OpenAIRE