The FDA recently announced the approval of Rinvoq (upadacitinib), AbbVie’s Janus kinase inhibitor (JAKi), to treat adults with moderately to severely active Crohn’s Disease (CD) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers. The decision was based on data from two randomised induction trials, U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849), and the subsequent maintenance study, U-ENDURE (NCT03345823). Rinvoq is expected to see a rapid uptake in the CD market by healthcare providers (HCPs) due to the overall positive sentiment associated with this therapy, according to GlobalData.
Adeleke Badejo, Senior Analyst – Immunology at GlobalData, comments, “Primary research involving US key opinion leaders (KOLs), conducted by GlobalData in February and March 2023, provided this favourable impression of the therapy, with one specialist stating Rinvoq is the ‘most promising agent’ and equating it with ‘Goldilocks’ porridge,’ achieving the proper balance of efficacy and safety.”
It is expected that the prescribing patterns of Rinvoq by HCPs will follow an ongoing trend by gastroenterologists to be more aggressive when treating CD to slow or prevent the progression of the disease. It is also anticipated that AbbVie will position Rinvoq to align with this direction of disease management, as evidenced by a sub-analysis of the U-EXCEED, U-EXCEL, and U-ENDURE trials presented at the Digestive Disease Week 2023 meeting in May. This presentation showed Rinvoq at 30mg to be effective in treating CD patients regardless of prior treatment with biologics, comparable to responses at the lower 15mg dose in biologic-naïve patients.
Badejo continues, “When asked about the findings during the Q&A segment following the presentation, the speaker stated the overall clinical message from this analysis is that the high dose of Rinvoq is more effective than the low dose in the high-risk patients’ cohort, adding that he would treat aggressively with the high dose in high-risk patients and only consider reducing dosage when confident that the patient’s disease is stable.”
In addition to the impression and efficacy of the therapy, Rinvoq being in pill form and the perceived preference of an oral route of administration by patients over the choices of intravenous (IV) and subcutaneous (subQ) administration with biologics will also supplement its incorporation into the CD treatment landscape. As with other JAKis, Rinvoq is accompanied by a boxed warning of increased risk of cardiovascular events (CVEs) and serious infections. However, based on general assessment, as expressed by interviewed KOLs, this advisory is not expected to significantly affect the adoption of this therapy in practices.
Badejo concludes, “On the heels of Rinvoq’s approval in CD, Sotyktu (deucravacitinib), the Bristol Myers Squibb tyrosine kinase (TYK2) selective JAKi currently in Phase 2 evaluation in CD is of particular interest, due to its lack of a boxed warning with its current prescribing information and perceived elevated safety profile within this drug class.”