P4339 - Efficacy and Safety of Etrolizumab in the Treatment of Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Fouad Jaber, MD, MS¹, Saqr Alsakarneh, MD¹, Mohammed Ayyad, MD², Tala Alsharaeh, MD³, Ahmed-Jordan Salahat, MD³, Mohammad Jaber, MD⁴, Yassine Kilani, MD⁵, Mohammad Aldiabat, MD⁶, Manesh Kumar Gangwani, MD⁷, Yazan Abboud, MD², Ahmed Fares, MD⁸, Dushyant S. Dahiya, MD⁹, Mohamed Ahmed, MD¹⁰, Yazan Sallam, MD¹¹, Richa Shukla, MD^12
1University of Missouri - Kansas City School of Medicine, Kansas City, MO; ²Rutgers New Jersey Medical School, Newark, NJ; ³The University of Jordan, Amman, 'Amman, Jordan; ⁴Al-Azhar University, Gaza, Palestinian Territories; ⁵SSM Health Saint Louis University Hospital, St. Louis, MO; ⁶Washington University in St. Louis, St. Louis, MO; ⁷University of Toledo, Toledo, OH; ⁸Tufts Medical Center, Boston, MA; ⁹The University of Kansas School of Medicine, Kansas City, KS; ¹⁰University of Missouri-Kansas City, Saint Luke's Hospital, Kansas City, MO; ¹¹University of Missouri, Kansas City, MO; ¹²Baylor College of Medicine, Houston, TX

Introduction: Etrolizumab is not yet commercially available for UC treatment. Despite the promising outcomes and safety profile of etrolizumab owing to its selective mechanism of action, the certainty behind its efficacy in the treatment of moderate to severe UC remains unclear. Our study aims to evaluate the effectiveness and safety of etrolizumab, a monoclonal antibody targeting integrin molecules, particularly the β7 subunit in α4β7 and αEβ7 integrin heterodimers, for the treatment of moderate to severe ulcerative colitis (UC).

Methods: We conducted a systematic review and meta-analysis, gathering randomized controlled trials (RCTs) from PubMed, Web of Science, SCOPUS, and Cochrane up to January 7th, 2023. Using a fixed-effect model, we pooled dichotomous data with RR and 95% CI for analysis.

Results: Five RCTs with a total of 1120 patients were included (Table 1). Etrolizumab was associated with a significantly increased clinical response (RR: 1.60, 95% CI [1.19, 2.14], P = 0.002) and clinical remission rates during both induction (RR: 1.83, 95% CI [1.39, 2.41], P < 0.0001) and maintenance phases (RR: 2.66, 95% CI [1.69, 4.19], P < 0.0001) (Figure-1). It also improved endoscopic outcomes, including endoscopic improvement (induction: RR: 1.55, 95% CI [1.29, 1.87], P < 0.0001; maintenance: RR: 1.69, 95% CI [1.24, 2.30], P = 0.0008) and endoscopic remission (induction: RR: 2.07, 95% CI [1.54, 2.80], P < 0.0001; maintenance: RR: 1.92, 95% CI [1.29, 2.85], P = 0.001), along with histological remission rates (induction: RR: 1.73, 95% CI [1.37, 2.17], P < 0.00001; maintenance: RR: 2.04, 95% CI [1.40, 2.98], P = 0.0002). No significant differences were observed in glucocorticoids-free remission (RR: 1.94, 95% CI [0.95, 3.94], P = 0.07) or remission maintenance (RR: 1.07, 95% CI [0.60, 1.91], P = 0.81) between etrolizumab and control groups. Safety profiles were comparable between etrolizumab and placebo groups with no significant differences in adverse events or serious adverse events leading to study treatment discontinuation or death.

Discussion: Our analysis suggests that etrolizumab is both safe and effective as an induction and maintenance therapy in the management of moderate to severe UC.



Disclosures:


Fouad Jaber, MD, MS¹, Saqr Alsakarneh, MD¹, Mohammed Ayyad, MD², Tala Alsharaeh, MD³, Ahmed-Jordan Salahat, MD³, Mohammad Jaber, MD⁴, Yassine Kilani, MD⁵, Mohammad Aldiabat, MD⁶, Manesh Kumar Gangwani, MD⁷, Yazan Abboud, MD², Ahmed Fares, MD⁸, Dushyant S. Dahiya, MD⁹, Mohamed Ahmed, MD¹⁰, Yazan Sallam, MD¹¹, Richa Shukla, MD¹². P4339 - Efficacy and Safety of Etrolizumab in the Treatment of Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.