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An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, Tolerability and Bioactivity of Subcutaneous ACTH Gel in Patients with
Muhammad Sohail Halim, MD
Presenter:
Muhammad Sohail Halim1,2, Rubbia Afridi1, Yael Sharon4, Farah Humayun1, Hajrah Sajid1, David Scales3, Mohamed Ahmed1, Quan Dong Nguyen2, David Chu4
Authors:
Affiliation:
1. Ocular Imaging Research and Reading Center, Sunnyvale, California
2. Byers Eye Institute, Stanford University, Palo Alto, California
3. Foresight Studies, San Antonio, TX
4. Metropolitan Eye Research & Surgery Institute, NJ
Purpose: To assess the safety, tolerability, and bioactivity of subcutaneous (SC) Acthar® Gel in patients with anterior scleritis.
Method: Subjects with active anterior scleritis (+1 to +3 grade) were enrolled in a phase II, open label, randomized, multicentered investigator-initiated study. Enrolled subjects were randomized into two treatment arms: Group 1: 80 U SC Acthar® Gel twice weekly; Group 2: 80 U SC Acthar® Gel thrice weekly. Subjects received active treatment till the primary endpoint (Week 16). Following which, the dose was adjusted or tapered off as per the participant’s response to treatment based on the retreatment criteria. Total study duration was 26 weeks. All subjects received prednisone at a max dose of 1mg/kg or equivalent at screening visit which was tapered off starting at baseline to week 9. Efficacy was assessed using 11-point pain intensity numerical rating scale (NRS) and scleritis grading scale.
Results: In this preliminary data analysis, fourteen (14) subjects were randomized into the study groups. The baseline demographics of the study participants is outlined in table 1A. Majority of the adverse events (AEs) in the twice weekly group (75%) and thrice weekly group (66%) were mild, non-ocular (92% vs. 55%) and non-related (92% vs 100%). The mean change from baseline in NRS, at week 26, was -1.13 for twice weekly group vs. -1.65 for thrice weekly group. 0/4 subjects from twice weekly group showed improvement in scleritis while 3/3 subjects showed at least 1-step improvement in scleritis grade at week 26 (Table. 1B). The mean change in BCVA, at week 26, was +5.59 and +5.26 for twice and thrice weekly respectively (Fig. 1).
Conclusion: Subcutaneous Acthar® Gel is well tolerated by patients with active anterior scleritis. Majority of the adverse events are mild, non-ocular and non-related. Thrice weekly Acthar® Gel improves the severity of scleritis more than twice weekly.
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