All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional.
The Lupus Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Introducing
Now you can personalise
your Lupus Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe Lupus Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lupus Hub cannot guarantee the accuracy of translated content. The Lupus Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
Safety of enpatoran in patients with active SLE/CLE: results from a phase Ib study
Bookmark this article
At the 14th European Lupus Meeting, Roy.1 presented safety findings from an ongoing phase Ib study of enpatoran by Wenzel et al.2 in patients with active SLE or cutaneous lupus erythematosus (CLE).1,2 Here, we summarize the key points.
Study design
-
This is a randomized, placebo-controlled, double-blind, dose-ascending trial (NCT04647708), exploring the maximal anticipated therapeutic range of oral enpatoran vs placebo in patients with active SLE/CLE (Figure 1).1,2
Figure 1. Study design*
CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; CLE, cutaneous lupus erythematosus; BID, twice-daily; SFU, safety follow-up; SLE, systemic lupus erythematosus; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.
*Adapted from Roy.1
†Cohort 4 was optional and was not activated.
-
This analysis was based on blinded data with a cut-off date of Aug 10, 2023.2
Key findings1,2
-
Out of 25 randomized patients, 20 completed treatment.
-
-
Two patients were undergoing treatment, while three had discontinued treatment due to reasons unrelated to safety.
-
-
Overall, 12 patients reported ≥1 treatment-emergent adverse event (TEAE; Figure 1).
-
-
93% of TEAEs were mild (n = 19) or moderate (n = 8) in severity.
-
One Grade 4 TEAE (laboratory abnormality of decreased lymphocyte count) was reported.
-
-
There were no instances of Grade 3 TEAEs, serious TEAEs, dose-limiting toxicities, adverse events of special interest, life-threatening TEAEs, or deaths (Figure 2).
-
No safety concerns were observed in the electroencephalogram and electroencephalogram findings.
-
-
No clinically significant abnormalities were noted in electrocardiogram readings.
-
All electroencephalogram results were within the normal limits.
-
Figure 2. Safety findings*
AE, adverse event; TEAE, treatment-emergent AE.
*Data from Roy.1
†Includes severe infections, seizures, serotonin syndrome, and clinically significant cardiac arrhythmias.
|
Key learnings |
|
- Roy S. Safety evaluation from an ongoing randomized, double-blind, multiple-ascending dose phase Ib study of enpatoran versus placebo in patients with active systemic or cutaneous lupus erythematosus (SLE/CLE). Abstract #P102. 14th European Lupus Meeting; March 21, 2024; Bruges, BE.
- Wenzel J, Abramova N, Weinelt D, et al. Safety evaluation from an ongoing randomized, double-blind, multiple-ascending dose phase Ib study of enpatoran versus placebo in patients with active systemic or cutaneous lupus erythematosus (SLE/CLE). Abstract #P102. Lupus Sci Med. 2024;11(Suppl_1):A1–A185. DOI: 10.1136/lupus-2024-el.156
Newsletter
Subscribe to get the best content related to lupus delivered to your inbox