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Abstract Number: 727

Repository Corticotropin Injection (H.P. Acthar® Gel) Attenuates Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE) Requiring Corticosteroids

Richard Furie1, Maya Das2, Daner Li2, Shanique Smythe2, Ericka Mathura2 and Patrice Becker2, 1Division of Rheumatology, North Shore LIJ Health System, Lake Success, NY, 2Research & Development, Mallinckrodt Pharmaceuticals, Ellicott City, MD

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Clinical Response, clinical trials and systemic lupus erythematosus (SLE)

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Session Information

Date: Sunday, November 8, 2015

Session Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:

Melanocortins such as corticotropin and alpha-MSH may modulate steroid-independent immune responses relevant to SLE pathophysiology. We previously reported that repository corticotropin injection (RCI), an FDA approved melanocortin therapeutic, attenuated B cell development, circulating autoantibody titers, and disease activity in a murine SLE model, supporting the efficacy of RCI as a treatment alternative for patients with SLE.

Methods:

This 8 wk double-blind randomized placebo-controlled study assessed clinical efficacy of RCI in patients with persistently active SLE despite moderate dose corticosteroids. The primary objective was to explore the effects of RCI on the Hybrid SLE Disease Activity Index (hSLEDAI), with key secondary objectives to evaluate effects on British Isles Lupus Assessment Group-2004 (BILAG), Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), and 28-joint count score. Patients were eligible if they had persistently active SLE (hSLEDAI >2) with arthritis and/or skin involvement and BILAG A or B in mucocutaneous and/ or musculoskeletal systems despite 7.5-30 mg prednisone daily for ≥ 4 wk prior to screening. 38 subjects were randomized to receive SC RCI 80 U every other day (RCI80; n=13) or 40 U daily (RCI40; n=13), or SC Placebo gel (n=12). Study medication was maintained at the assigned regimen for 4 wk, then tapered over 4 wk to 2x/wk administration of the assigned dose. Clinical response was assessed by change from baseline for hSLEDAI (wk 2, 4, 6 & 8), BILAG, CLASI, and Tender & Swollen Joint Count (wk 4 & 8).

Results:

Mean hSLEDAI scores at baseline were 9.8±2.1, 8.7±2.9, 11.3±3.3, and 10.0±3.3 in the Placebo, RCI40, RCI80, and combined RCI groups, respectively (mean ±SD). Baseline BILAG and CLASI scores were similar between groups, though tender swollen joint count was higher in subjects randomized to RCI80 vs RCI40 or Placebo (p≤ 0.05). RCI led to significant improvement in key efficacy endpoints compared with Placebo, including total hSLEDAI and BILAG scores, CLASI Activity, and Tender & Swollen Joint Count. There were no significant differences in the incidence of treatment-emergent adverse events between groups.

Activity index

change from baseline

Time

Placebo

LS mean (SE)

RCI 40U QD

LS mean (SE)

RCI 80U QOD

LS mean (SE)

RCI (combined)

LS mean (SE)

hSLEDAI

4 wk

-1.2 (0.6)

-1.2 (0.6)

-2.1 (0.6)

-1.6 (0.4)

6 wk

-1.4 (0.7)

 

-2.9 (0.7)

 

-3.5 (0.7)*

*p=0.045

-3.2 (0.5)*

*p=0.040

8 wk

-0.8 (0.9)

-3.7 (0.9)*

*p=0.026

-3.9 (0.9)*

*p=0.020

-3.8 (0.6)*

*p= 0.008

BILAG

4 wk

-4.7 (1.6)

-5.2 (1.5)

-7.2 (1.6)

-6.1 (1.1)

8 wk

-1.8 (1.5)

-8.1 (1.4)*

*p=0.005

-9.3 (1.6)*

*p=0.002

-8.6 (1.0)*

*p=0.001

CLASI Activity

4 wk

-0.2 (0.7)

-2.2 (0.7)*

*p=0.051

-1.7 (0.7)

-2.0 (0.5)*

*p=0.050

8 wk

-0.6 (1.0)

-3.7 (1.0)*

*p=0.030

-2.3 (1.1)

-3.1 (0.7)*

*p=0.047

Tender & Swollen Joint Ct

4 wk

-2.5 (0.8)

-2.3 (0.7)

-3.5 (0.8)

-2.8 (0.5)

8 wk

-2.5 (0.5)

-2.8 (0.5)

-4.4 (0.6)*

*p=0.019

-3.5 (0.4)

Conclusion:

These data demonstrate that RCI reduces disease activity in patients requiring corticosteroids for persistently active SLE, and that improvements occur within 8 wk of treatment initiation. The tolerability, steroid-sparing effects, and impact of RCI on long-term disease control are being further evaluated in an ongoing open-label extension of this study.


Disclosure: R. Furie, Mallinckrodt Pharmaceticals, 9; M. Das, Mallinckrodt Pharmaceuticals, 9,Mallinckrodt Pharmaceuticals, 1; D. Li, Mallinckrodt Pharmaceuticals, 3,Mallinckrodt Pharmaceuticals, 1; S. Smythe, Mallinckrodt Pharmaceuticals, 3,Mallinckrodt Pharmaceuticals, 1; E. Mathura, Mallinckrodt Pharmaceuticals, 3,Mallinckrodt Pharmaceuticals, 1; P. Becker, Mallinckrodt Pharmaceuticals, 3,Mallinckrodt Pharmaceuticals, 1.

To cite this abstract in AMA style:

Furie R, Das M, Li D, Smythe S, Mathura E, Becker P. Repository Corticotropin Injection (H.P. Acthar® Gel) Attenuates Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE) Requiring Corticosteroids [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/repository-corticotropin-injection-h-p-acthar-gel-attenuates-disease-activity-in-patients-with-persistently-active-systemic-lupus-erythematosus-sle-requiring-corticosteroids/. Accessed April 13, 2021.
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