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OBJECTIVE: To review the pharmacologic and clinical profile of mirikizumab in the treatment of moderate to severe ulcerative colitis (UC). DATA SOURCES: A PubMed search was performed from inception to December 2023 using keywords mirikizumab, interleukin-23 inhibitor, and UC. Information was also obtained from package inserts as well as published abstracts. STUDY SELECTION AND DATA EXTRACTION: Phase 3 studies plus relevant literature on mirikizumab pharmacologic and clinical profile were reviewed. DATA SYNTHESIS: Mirikizumab approval was based on LUCENT-1 and LUCENT-2. In the phase 3 studies involving patients with moderate to severe UC, mirikizumab, when compared to placebo, resulted in clinical remission in a significantly higher proportion of patients in both the induction and maintenance phase. In addition, mirikizumab met the secondary endpoints of alternate definition of clinical remission, endoscopic remission, glucocorticoid-free clinical remission, histologic-endoscopic mucosal remission, and improvement in bowel urgency status, bowel-urgency remission, and maintenance of clinical remission. Common adverse events noted include infection (15.1%), injection-site reaction (8.7%), nasopharyngitis (7.2%), and headache (3.3%). RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON TO EXISTING AGENTS: Mirikizumab is the first selective interleukin 23 (IL-23) inhibitor approved for UC. Additional studies are required to determine how to position mirikizumab in both biologic-naïve and biologic-experienced patients with moderate to severe UC. CONCLUSION: Mirikizumab provides a novel mechanism of action for the treatment of moderate to severe UC and is another welcomed treatment advance in the treatment arsenal, providing a more selective mechanism of action while maintaining a comparable safety profile.
ABSTRACT
OBJECTIVE: To review the pharmacologic and clinical profile of risankizumab-rzaa in the treatment of Crohn's disease (CD). DATA SOURCES: A PubMed search was performed from inception to August 2022 using keywords risankizumab, risankizumab-rzaa, interleukin-23 inhibitor, and Crohn's disease. Information was obtained from package inserts as well as published abstracts. STUDY SELECTION AND DATA EXTRACTION: Phase 2 and 3 studies plus relevant literature on risankizumab-rzaa pharmacologic and clinical profile were reviewed. DATA SYNTHESIS: Risankizumab-rzaa approval was based on ADVANCE, MOTIVATE, and FORTIFY. In these 3 phase 3 studies involving patients with moderate to severe CD, risankizumab-rzaa, when compared with placebo, resulted in clinical remission and endoscopic response in a significantly higher proportion of patients in both the induction and maintenance phase. In addition, risankizumab-rzaa met the secondary endpoints of clinical response, endoscopic improvement, corticosteroid-free remission, and mucosal healing. Common adverse events noted include nasopharyngitis, arthralgia, headache, abdominal pain, and nausea. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Risankizumab-rzaa is the first selective IL-23 inhibitor approved for CD and provides an additional therapeutic option for patients, particularly those who have been previously treated with other advanced inflammatory bowel disease therapies. Additional studies are required to determine how to best position risankizumab-rzaa in both bio-naïve and bio-experienced patients with CD. CONCLUSIONS: Risankizumab-rzaa is the most recent therapeutic advance for CD. It has a selective mechanism of action with a similar safety profile comparable with other currently approved advanced therapies.
Subject(s)
Crohn Disease , Humans , Crohn Disease/drug therapy , Antibodies, Monoclonal/adverse effects , Remission InductionABSTRACT
INTRODUCTION: Smoking is the number one preventable cause of death in the United States. Under the Affordable Care Act, Kansas Medicaid covers all seven FDA-approved smoking cessation therapies. However, it is estimated only 3% of Kansas Medicaid smokers use treatment compared to the national estimate of 10%. The objective is to determine systemic barriers in place that prevent optimal utilization of Medicaid smoking cessation benefits among KU Medical Center Internal Medicine patients. METHODS: For this quality improvement project, a population of 169 Kansas Medicaid smokers was identified who had been seen at the KU Internal Medicine Clinic from January 1, 2015 - February 16, 2016. Phone surveys were completed with 62 individuals about smoking status, interest in using smoking cessation treatment options, and awareness of Medicaid coverage of treatment. RESULTS: Of the 62 respondents, 24 (39%) were prescribed pharmacotherapy and 41 (66%) were interested in using smoking cessation treatment. There were eight who had quit smoking. Of the remaining 54 smokers, 31 (57%) were unaware that Medicaid would cover pharmacotherapy. Of 24 participants who received a prescription for pharmacotherapy, 13 (54%) were able to fill the prescription at no cost using the Medicaid benefit. CONCLUSIONS: The majority of respondents were interested in using smoking cessation treatment yet three main barriers existed to using Medicaid smoking cessation benefits: physicians not prescribing treatment to patients, patients not aware of Medicaid coverage, and inadequate pharmacy filling. Improved physician and patient awareness of Medicaid coverage will facilitate more patients receiving smoking cessation therapy and ultimately quitting smoking.