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Most of the data on vedolizumab has been limited by small sample sizes and short follow-up.
A team, led by Daniela Pugliese, EMAD – IBD UNIT - Unità Operativa Complessa di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, evaluated the real-life long-term effectiveness and safety of vedolizumab in a large cohort of IBD patients.
Previous studies have shown the effectiveness and safety of vedolizumab in clinical practices. However, the majority of the studies are limited by small sample sizes of patients and at most one-year of follow-up data.
In the Long-Term Italian Vedolizumab Effectiveness (LIVE) trial, the researchers examined 564 Crohn’s disease and 547 ulcerative colitis patients who started vedolizumab between April 2016 and June 2017 at 47 centers of the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Each patient was prospectively followed-up with until June 2019.
The investigators sought primary endpoints of vedolizumab persistence and various secondary endpoints, including steroid-free clinical remission (SFCR), C-reactive protein (CRP) normalization, deep remission, and rates of adverse events (AEs).
The mean age at baseline was 47.7 years old and the mean disease duration was 11.8 years old. In addition, 256 (23%) patients were biologic-naïve, while the cumulative vedolizumab treatment persistence at 12 and 24 months was 73.3% and 67.3%, respectively.
There was a significantly longer persistence found in the biologic-naïve Crohn’s disease patient cohort when compared to biologic experienced patients (P = 0.04). However, there was no significant difference observed for ulcerative colitis patients.
Vedolizumab interval escalation was needed in 24.4% (n = 218) of patients at 12 months, as well as 22.8% (n = 146) of patients at 24 months. SFCR, which was defined as clinical remission, according to Harvey-Bradshaw index or partial Mayo score, and no steroid therapy in the previous 3 months, was identified in 34.3% (n = 193) and 31.% (n = 178) of Crohn’s disease patients.
This was also true in 41.9% (n = 205) and 42.6% (n = 215) of ulcerative colitis patients.
In addition, mean CRP levels decreased from 12.4 mg/L at baseline to 7.5 mg/L at months and 5.7 mg/L at 24 months and CRP normalization occurred in 533 (44.1%) and 432 (39.1%) of patients, at 12 and 24 months.
For the patient subgroup with available follow-up endoscopy, deep remission, which was defined as combined clinical and endoscopic remission, according to the Simple Endoscopic Score for CD or endoscopic Mayo score, was found in 15.9% (n = 22) and 23.7% (n = 23) of Crohn’s disease patients, as well as in 25.8% (n = 47) and 43.8% (n = 46) of ulcerative colitis patients, at 12 and 24 months, respectively.
For the safety profile of the treatment, 230 (20.8%) patients experienced at least 1 adverse event, including 58 (5.2%) events that caused vedolizumab withdrawal. The most common adverse events were infections, while 27 (2.4%) patients received a new cancer diagnosis.
“In this preliminary analysis of the largest reported real-world cohort of IBD patients treated with vedolizumab, more than 65% of patients persisted on therapy with a favorable safety profile after 2 years,” the authors wrote.
The study, “Italian Real-Life Study Evaluating The Long-Term Effectiveness Of Vedolizumab For The Treatment Of Inflammatory Bowel Disease,” was published online by DDW.