The favorable results from the 84-patient study may, in part, depend on some of the definitions used.
Rinvoq (upadacitinib) is a safe and effective treatment option for both ulcerative colitis and Crohn’s disease , according to a recent real-world study out of the University of Chicago. In this study of medically resistant patients with ulcerative colitis or Crohn’s diease, including some who previously took Xeljanz (tofacitinib), treatment with Rinvoq led to clinical and objective response and remission, with clinical improvement seen as soon as the second week of therapy for some participants.
Ulcerative colitis and Crohn’s diseases are types of inflammatory bowel disease. Traditionally, nonspecific anti-inflammatory drugs and immunomodulatory agents have been used to treat many patients with inflammatory bowel disease, but some people do not respond to those treatments or find the side effects intolerable.
In the past few decades, advances in identifying the underlying pathology of autoimmune diseases, which have an inflammatory component, have led to the development of new drugs such as Rinvoq. It works by inhibiting Janus kinases, a subset of tyrosine kinases that play a role in fomenting the dysregulated immunological response and inflammation that underlie ulcerative colitis and Crohn’s disease.
Rinvoq is FDA-approved for the treatment of various autoimmune diseases, including moderate to severe ulcerative colitis and Crohn’s disease. Specifically, the drug is indicated for adults who haven’t responded or are unable to tolerate tumor necrosis factor blocker drugs, such Humira (adalimumab).
The new study, published in Clinical Gastroenterology and Hepatology, focuses on the real-world application of Rinvoq for ulcerative colitis and Crohn’s disease. While clinical trials provide sufficient evidence to confirm baseline safety and effectiveness, researchers can learn more about a drug in the context of a diverse, real-world population by collecting data during the routine provision of healthcare and then analyzing the data for patterns of efficacy and safety,
Corresponding author David T. Rubin, M.D., of the University of Chicago Inflammatory Bowel Disease Center, and his coauthors analyzed the disease status and severity of patients with ulcerative colitis or Crohn’s disease at baseline and at two, four, and eight weeks into treatment with Rinvoq. They assessed clinical response or clinical remission of inflammatory bowel disease based on a standard measurement of colitis severity. The investigators also collected information on adverse events. The real-world data was then compared to data from previous clinical trials.
The investigators included 44 patients with ulcerative colitis and 40 patients with Crohn’s disease in their study. All of them had previously tried other treatments, including biologic therapies or other Janus kinase inhibitors. To reflect real-world practice, no wash-out period was required between prior therapies and when patients started taking Rinvoq.
Following eight weeks of Rinvoq treatment, 23 of 27 (85.2%) patients with ulcerative colitis experienced a clinical response and 22 of 27 (81.5%) experienced clinical remission. In those with Crohn’s disease, 13 of 17 (76.5%) experienced clinical response and 12 of 17 (70.6%) experienced clinical remission following eight weeks of Rinvoq treatment.
These real-world response and remission rates were similar to, or greater than, the results seen in the clinical trials of Rinvoq.
From a safety perspective, adverse events of real-world Rinvoq treatment were similar to that of clinical trials. Acne was the most commonly reported side effect.
Regarding their findings, the Rubin and his co-authors wrote: “It is notable that our response and remission rates are greater than the pivotal phase 3 trials of upadacitinib in UC and CD, despite a generally more treatment-resistant cohort in this real-world experience.”
They described the results as “very reassuring,” but also added the proviso that the results may be related, in part, to differences in the definitions used.
They summed up that in this “large real-world experience” in medically resistant patients, Rinvoq is rapidly effective and safe, including in those who had previously taken Xeljanz.