Background Two Phase 2 studies investigating once-daily cenerimod, a selective sphingosine 1-phosphate 1 receptor modulator, in adults with SLE were recently completed: CARE (NCT03742037) and ID-064A203.
Methods The CARE study was previously described.1 Adults with moderate to severe SLE were randomised to placebo or cenerimod (0.5, 1, 2 or 4 mg). At Month (M) 6, patients receiving cenerimod 4 mg were re-randomised to placebo or cenerimod 2 mg for M7-12; patients from other groups continued their initial treatment to M12. The primary endpoint was change from baseline to M6 in SLEDAI-2K score modified to exclude leukopenia (mSLEDAI-2K).
ID-064A203, performed in Japan, randomised adults with moderate to severe SLE to 2 or 4 mg cenerimod for 3 months with end-of-study at M9. The primary endpoint was occurrence of treatment-emergent adverse events (AEs), serious AEs and AEs of special interest. The secondary endpoint was change from baseline to each post-baseline assessment (PBA) until M9 in total lymphocyte count. Exploratory endpoints included change from baseline to each PBA until M9 in mSLEDAI-2K, physician’s global assessment and biomarkers.
In both studies, patients continued their SLE background therapies, and oral corticosteroid (OCS) dose should have been maintained stable for ≥15 days before randomisation. It was preferable for OCS dose to be maintained stable until M3 in ID-064A203, and to the end of M6 in CARE.
Results Results from ID-064A203 will be available in 2023.
CARE results were presented;1 the primary endpoint was not met after adjustment for multiplicity (nominal p=0.0291 for cenerimod 4 mg versus placebo), although reduction in disease activity at M6 was observed.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.