ITALIAN REAL-LIFE STUDY EVALUATING THE LONG-TERM EFFECTIVENESS OF VEDOLIZUMAB FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE
DDW ePoster Library. PUGLIESE D. 05/23/21; 320936; Su459
Abstract
Discussion Forum (0)
Engage with the presenter here during ePoster Session: IBD: Uncontrolled Therapeutic Observations in Humans Biologic
On Sunday, May 23, 2021 12:15 - 1 p.m. EDT

Number: Su459
ITALIAN REAL-LIFE STUDY EVALUATING THE LONG-TERM EFFECTIVENESS OF VEDOLIZUMAB FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE

Society: AGA
Track: Inflammatory Bowel Diseases
Category: Immunology‚ Microbiology & Inflammatory Bowel Diseases

Author(s): Daniela Pugliese1, Giuseppe Privitera2, Alessandro Armuzzi1,21 CEMAD – IBD UNIT - Unità Operativa Complessa di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy; 2 Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy

Background
Real-world studies confirmed Vedolizumab effectiveness and safety in clinical practice, but most of them are limited by small sample size and at most 1-year of follow-up. The aim of our study is to evaluate the real-life long-term effectiveness and safety of Vedolizumab in a large cohort of IBD patients.
Methods
The Long-term Italian Vedolizumab Effectiveness (LIVE) study included CD and UC patients started on vedolizumab from April 2016 to June 2017 at 47 centers of the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Patients were prospectively followed-up until June 2019. The primary endpoint was vedolizumab persistence. Secondary endpoints included: steroid-free clinical remission (SFCR), C-reactive protein (CRP) normalization, deep remission and rates of adverse events (AEs).
Results
One-thousand one-hundred and eleven patients (564 CD and 547 UC) were enrolled. At baseline, mean age was 47.7 (± 16) years and mean disease duration was 11.8 (± 8.8) years; 256 (23%) patients were biologic-naïve. Cumulative vedolizumab treatment persistence at 12 and 24 months was 73.3% and 67.3%, respectively. A significantly longer persistence was observed among biologic-naïve CD patients compared to biologic-experienced (p=0.04), while no significant difference was observed in UC. Vedolizumab interval escalation was necessary in 218 (24.4%) patients at 12 months and in 146 (22.8%) at 24 months. SFCR (defined as clinical remission, according to Harvey-Bradshaw index or partial Mayo score, and no steroid therapy in the previous 3 months) was reported in 193 (34.3%) and 178 (31.6%) CD patients, and in 205 (41.9%) and 215 (42.6%) UC patients, at 12 and 24 months, respectively. Mean CRP levels dropped from 12.4 (±17.9) mg/L at baseline to 7.5 (±12.6) mg/L at 12 months and 5.7 mg/L (±8.8) at 24 months. CRP normalization occurred in 533 (44.1%) and 432 (39.1%) of patients, at 12 and 24 months. Among patients with available follow-up endoscopy, deep remission (defined as combined clinical and endoscopic remission, according to Simple Endoscopic Score for CD or endoscopic Mayo score) was reported in 22/138 (15.9%) and 23/97 (23.7%) CD patients, and in 47/182 (25.8%) and 46/105 (43.8%) UC patients, at 12 and 24 months, respectively. Two hundred and thirty patients (20.8%) experienced at least 1 adverse event, causing Vedolizumab withdrawal in 58 (5.2%) of them. The most common AEs were infections. Twenty-seven (2.4%) patients received new cancer diagnosis.
Conclusion
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.
Engage with the presenter here during ePoster Session: IBD: Uncontrolled Therapeutic Observations in Humans Biologic
On Sunday, May 23, 2021 12:15 - 1 p.m. EDT

Number: Su459
ITALIAN REAL-LIFE STUDY EVALUATING THE LONG-TERM EFFECTIVENESS OF VEDOLIZUMAB FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE

Society: AGA
Track: Inflammatory Bowel Diseases
Category: Immunology‚ Microbiology & Inflammatory Bowel Diseases

Author(s): Daniela Pugliese1, Giuseppe Privitera2, Alessandro Armuzzi1,21 CEMAD – IBD UNIT - Unità Operativa Complessa di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy; 2 Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy

Background
Real-world studies confirmed Vedolizumab effectiveness and safety in clinical practice, but most of them are limited by small sample size and at most 1-year of follow-up. The aim of our study is to evaluate the real-life long-term effectiveness and safety of Vedolizumab in a large cohort of IBD patients.
Methods
The Long-term Italian Vedolizumab Effectiveness (LIVE) study included CD and UC patients started on vedolizumab from April 2016 to June 2017 at 47 centers of the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Patients were prospectively followed-up until June 2019. The primary endpoint was vedolizumab persistence. Secondary endpoints included: steroid-free clinical remission (SFCR), C-reactive protein (CRP) normalization, deep remission and rates of adverse events (AEs).
Results
One-thousand one-hundred and eleven patients (564 CD and 547 UC) were enrolled. At baseline, mean age was 47.7 (± 16) years and mean disease duration was 11.8 (± 8.8) years; 256 (23%) patients were biologic-naïve. Cumulative vedolizumab treatment persistence at 12 and 24 months was 73.3% and 67.3%, respectively. A significantly longer persistence was observed among biologic-naïve CD patients compared to biologic-experienced (p=0.04), while no significant difference was observed in UC. Vedolizumab interval escalation was necessary in 218 (24.4%) patients at 12 months and in 146 (22.8%) at 24 months. SFCR (defined as clinical remission, according to Harvey-Bradshaw index or partial Mayo score, and no steroid therapy in the previous 3 months) was reported in 193 (34.3%) and 178 (31.6%) CD patients, and in 205 (41.9%) and 215 (42.6%) UC patients, at 12 and 24 months, respectively. Mean CRP levels dropped from 12.4 (±17.9) mg/L at baseline to 7.5 (±12.6) mg/L at 12 months and 5.7 mg/L (±8.8) at 24 months. CRP normalization occurred in 533 (44.1%) and 432 (39.1%) of patients, at 12 and 24 months. Among patients with available follow-up endoscopy, deep remission (defined as combined clinical and endoscopic remission, according to Simple Endoscopic Score for CD or endoscopic Mayo score) was reported in 22/138 (15.9%) and 23/97 (23.7%) CD patients, and in 47/182 (25.8%) and 46/105 (43.8%) UC patients, at 12 and 24 months, respectively. Two hundred and thirty patients (20.8%) experienced at least 1 adverse event, causing Vedolizumab withdrawal in 58 (5.2%) of them. The most common AEs were infections. Twenty-seven (2.4%) patients received new cancer diagnosis.
Conclusion
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.
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