Results From Review of Real-World Studies of Advanced Therapies in Moderate-to-Severe Ulcerative Colitis

The severity of ulcerative colitis (UC) is classified as mild, moderate or severe based on symptoms and clinical findings. The main goal of treatment remains to induce and maintain remission from the mucosal inflammation symptoms associated with the disease. Currently, there are several advanced therapies approved to treat moderate-to-severe UC. These include biologics, such as tumor necrosis factor (TNF) inhibitors, interleukin (IL)-12/23 and IL-23 inhibitors, and an anti-integrin agent. Small molecules, such as Janus kinase (JAK) inhibitors and sphingosine 1-phosphate receptor modulators, are also in the picture.

Although randomized controlled trials are the gold standard for establishing the safety and efficacy of treatments and gaining regulatory approval, results are often not generalizable given the rigid inclusion criteria necessary for minimizing potential confounders in clinical trials. More and more, real-world studies are becoming useful in clinical practice, as they are more likely to represent a generalized population.

According to Peter M. Irving, M.D., from the gastroenterology department at Guy’s and Thomas’ Hospital in London and his colleagues, there is scant comprehensive research assessing the safety and efficacy of currently available advanced therapies for moderate-to-severe UC in a real-world setting. To address this gap, Irving and his colleagues conducted a systematic review of real-world studies evaluating the safety and efficacy of advanced therapies in adults with moderate-to-severe UC.

The review results were published in the September 2024 issue of the Journal of Managed Care and Specialty Pharmacy.

The review included 139 studies published between 2005 and 2022. The following treatments were assessed in the included studies: the integrin receptor inhibitor Entyvio (vedolizumab), the JAK inhibitor Xeljanz (tofacitinib), the IL-12/23 inhibitor Stelara (ustekinumab), and the TNF inhibitors Humira (adalimumab), Simponi (golimumab), and Remicade (infliximab).

Results showed Entyvio and Xeljanz as the most commonly studied therapies. When the two were compared, Xeljanz showed higher remission rates. When comparing Entyvio with TNF inhibitors, Entyvio came out on top in terms of remission rates. When looking at steroid-free clinical remission rates, Xeljanz and Stelara had similar outcomes. Within the group of TNF inhibitors, Remicade was the most effective. Lastly, the safety profiles were similar across all therapies.

The authors noted that study limitations, such as small sample sizes and variations in definitions of clinical remission, study design, and patient characteristics, warrant further research exploring these gaps. However, the current findings can be valuable in guiding clinicians treating patients with moderate-to-severe ulcerative colitis.

This study was sponsored by Pfizer, maker of Xeljanz .