Mohamed Farghaly, MBBCh1, Youssef Elaraby, MBBCh2, Ayten Aboudeif, MBBCh3, Monica Medhat, MBBCh4, Dina Hamed, MBBCh5, Farah Taha, MBBCh6, Patricia Farag, MBBCh4, Mai Abouzaid, MBBCh5, Ola N. Moustafa, MBBCh7, Mahmoud M. Elsayed, MD8 1New Giza University, 6th of October, Al Jizah, Egypt; 2New Giza university, New Cairo, Al Qahirah, Egypt; 3New Giza University, Maadi, Al Qahirah, Egypt; 4New Giza University, Heliopolis, Al Qahirah, Egypt; 5New Giza University, Nasir City, Al Qahirah, Egypt; 6New Giza University, Mohandseen, Al Jizah, Egypt; 7New Giza University, New Cairo, Al Qahirah, Egypt; 8MME Foundation, Monsoura, Ad Daqahliyah, Egypt Introduction: Ulcerative colitis (UC) is a chronic inflammatory bowel disease requiring long-term management. While conventional therapies offer relief for some, many patients remain refractory, prompting a shift toward novel biologics. Recent clinical trials have introduced agents with promising efficacy and safety profiles, but comparative clarity is lacking.
To systematically evaluate the efficacy and safety of recently approved biological therapies for moderate-to-severe UC, providing a contemporary synthesis to guide clinical decision-making.
Methods: We conducted a systematic review following PRISMA guidelines. Databases including PubMed, EMBASE, and Cochrane Central were searched through April 2024 for randomized controlled trials (RCTs) investigating novel biologics in UC, such as etrasimod, mirikizumab, ozanimod, and vedolizumab SC. Outcomes included clinical remission, clinical response, endoscopic improvement, and treatment-emergent adverse events (TEAEs). Risk of bias was assessed using the Cochrane Risk of Bias tool, and summary statistics were generated using R (meta and metafor packages). Results: Fourteen RCTs met inclusion criteria (N=8,612). Mirikizumab demonstrated superior clinical remission rates at week 12 (RR 2.24, 95% CI 1.71–2.94) compared to placebo. Etrasimod significantly improved endoscopic scores (RR 1.96, 95% CI 1.43–2.68). Ozanimod yielded moderate efficacy but with higher TEAEs, including headache and elevated liver enzymes. Subcutaneous vedolizumab was comparable to intravenous administration, with favorable safety. Across agents, biologics were well tolerated; the most common adverse events included nasopharyngitis, injection site reactions, and transient liver enzyme elevations. Serious infections remained rare. Discussion: Emerging biological therapies for UC show robust efficacy and acceptable safety profiles, offering expanded therapeutic options for patients refractory to conventional treatments. Mirikizumab and etrasimod exhibit particularly strong remission and mucosal healing benefits. This systematic review provides critical insights to inform personalized treatment approaches in IBD management.
Disclosures: Mohamed Farghaly indicated no relevant financial relationships. Youssef Elaraby indicated no relevant financial relationships. Ayten Aboudeif indicated no relevant financial relationships. Monica Medhat indicated no relevant financial relationships. Dina Hamed indicated no relevant financial relationships. Farah Taha indicated no relevant financial relationships. Patricia Farag indicated no relevant financial relationships. Mai Abouzaid indicated no relevant financial relationships. Ola N. Moustafa indicated no relevant financial relationships. Mahmoud M. Elsayed indicated no relevant financial relationships.
Mohamed Farghaly, MBBCh1, Youssef Elaraby, MBBCh2, Ayten Aboudeif, MBBCh3, Monica Medhat, MBBCh4, Dina Hamed, MBBCh5, Farah Taha, MBBCh6, Patricia Farag, MBBCh4, Mai Abouzaid, MBBCh5, Ola N. Moustafa, MBBCh7, Mahmoud M. Elsayed, MD8. P3225 - Efficacy and Safety of Novel Biological Therapies in Ulcerative Colitis: A Systematic Review, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.
