Objective To review the pharmacological and clinical profile of ozanimod in the treatment of ulcerative colitis (UC). Data Sources A PubMed search was conducted from inception to July 2021 using the keywords ozanimod, ulcerative colitis, and sphingosine 1-phosphate receptor modulator. Information was also extracted from published abstracts and the package insert. Study Selection and Data Extraction Phase 2 and 3 studies and relevant literature on ozanimod pharmacological and clinical profiles were reviewed. Data Synthesis Ozanimod approval was based on True North, a phase 3 trial evaluating ozanimod’s efficacy and safety in the treatment of moderate to severe UC. Compared with placebo, ozanimod led to clinical remission in a significantly higher proportion of patients in both the induction and maintenance phase. Additionally, for secondary end points of clinical response, endoscopic improvement, corticosteroid-free remission, and mucosal healing, ozanimod performed significantly better than placebo. Common adverse events included infections, headaches, hypertension, bradycardia, and liver enzyme elevations. Relevance to Patient Care and Clinical Practice Ozanimod is the first sphingosine 1-phosphate modulator to be approved for UC and is administered orally. Its efficacy profile is comparable with other UC medications. However, its safety profile is unique, requiring extensive assessments prior to initiation of and during treatment. Thus, it is unclear how ozanimod will be positioned in UC treatment. Conclusion Ozanimod is another option in the growing arsenal of UC treatment. Although it offers a novel mechanism of action and is administered orally, there are important safety, dosing, and pharmacokinetic factors to consider prior to initiation and use.

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Background A new formulation of once daily extended-release tacrolimus (LCP-tac, Envarsus XR) was approved for use in the USA for kidney transplant recipients in 2015. There are limited data regarding real-world observations with conversion to LCP-tac in liver transplant recipients. Methods We performed a retrospective analysis of liver transplant recipients treated with LCP-tac. Data collection included (1) reasons for switching to LCP-tac; (2) conversion ratio used; (3) kidney function at time of conversion and 3 months after; (4) outcomes of conversion [acute cellular rejection rates and cytomegalovirus (CMV) viremia] within 3 months of conversion. Results Average conversion ratio used to achieve therapeutic drug level without further dose adjustment was 1:0.73 (SD 0.11). Median time after transplant was 508 days (IQR 736). Common reasons patients were switched to LCP-tac were from fluctuations in tacrolimus levels (44%) and adverse effect of tremor (32%). Among patients who were switched due to tremors 88% noted significant improvement. There was no difference in serum creatinine (P = 0.55) or glomerular filtration rate (P = 0.64) from baseline to 3 months postconversion. There were no episodes of acute cellular rejections or CMV viremia postconversion. Conclusion This observational study demonstrated that conversion of immediate-release tacrolimus to LCP-tac in liver transplant recipients was well tolerated and effective.

Lay Summary Despite a high approval rate, there were unnecessary delays in therapy due to prior authorizations. This study identified the impact of type of IBD, FDA-labeled indication, and dose escalations on approvals.