Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Askanase AD, Zhao E, Zhu J, Bilyk R, Furie RA

Rheumatology and therapy29 Sept 2020Cited by 17 (Europe PMC)

PMID32996096PMCIDPMC7695765DOI10.1007/s40744-020-00236-1PepBankPUB-32996096

Read at source PubMedAsk about this study

CorrectedReported by Europe PMC

The publisher issued a correction. Read the notice to see what changed. PepBank shows the study as the source lists it today.

Correction notice on PubMed (PMID 34460089) (opens in a new tab)Correction notice, Europe PMC, seen 27 Oct 2026

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with active SLE, repository corticotropin gel yielded 47.6% SRI-4 response versus 43.5% with placebo, without a significant difference.
In plain wordsIn adults with active lupus, SRI-4 response was numerically higher with repository corticotropin gel than placebo, without a significant difference.
Peptide
ACTH (corticotropin)
Outcome
IncreaseSRI-4 response at week 16
Study
n = 169
Comparator
Placebo
Analysis
Primary
Outcome group
Immune response · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Measurements
SRI-4 response
47.6%
RCI
SRI-4 response
43.5%
placebo
Odds ratio
1.2
RCI versus placebo
95% CI
0.6 to 2.2
odds ratio
p
0.5762
between groups
Source sentences
Summary
In the modified intention-to-treat population (RCI, n = 84; placebo, n = 85), the proportion of SRI-4 responders at week 16 was not significantly different between groups (RCI, 47.6%; placebo, 43.5%; OR [95% CI] 1.2 [0.6 to 2.2]; p = 0.5762).
4 context sentences(design, population, supporting numbers)
Summary · context
Despite failure to achieve the primary endpoint, these results support the utility of RCI for treating persistently active SLE.
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609601
02HumanRandomized controlled trialEfficacy outcome
In adults with active SLE, post hoc analysis found more BICLA responders with repository corticotropin gel than placebo at week 4.
In plain wordsIn adults with active lupus, a post hoc analysis found more BICLA responders with repository corticotropin gel than placebo at week 4.
Peptide
ACTH (corticotropin)
Outcome
IncreaseBICLA response at week 4
Study
n: not reported in source
Comparator
Placebo
Outcome group
Immune response · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
Post hoc analyses demonstrated a greater proportion of BILAG-based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 ≥ 10 and CLASI-Activity ≥ 11.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609605
03HumanRandomized controlled trialEfficacy outcome
In adults with active SLE, post hoc analysis found more BICLA responders with repository corticotropin gel than placebo at week 12.
In plain wordsIn adults with active lupus, a post hoc analysis found more BICLA responders with repository corticotropin gel than placebo at week 12.
Peptide
ACTH (corticotropin)
Outcome
IncreaseBICLA response at week 12
Study
n: not reported in source
Comparator
Placebo
Outcome group
Immune response · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
Post hoc analyses demonstrated a greater proportion of BILAG-based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 ≥ 10 and CLASI-Activity ≥ 11.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609606
04HumanRandomized controlled trialEfficacy outcome
In adults with active SLE, post hoc analysis found more BICLA responders with repository corticotropin gel than placebo at week 20.
In plain wordsIn adults with active lupus, a post hoc analysis found more BICLA responders with repository corticotropin gel than placebo at week 20.
Peptide
ACTH (corticotropin)
Outcome
IncreaseBICLA response at week 20
Study
n: not reported in source
Comparator
Placebo
Outcome group
Immune response · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
Post hoc analyses demonstrated a greater proportion of BILAG-based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 ≥ 10 and CLASI-Activity ≥ 11.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609607
05HumanNon-randomized trialEfficacy outcome
In adults with active SLE, repository corticotropin gel reduced 28 SJC/TJC from baseline to week 16.
In plain wordsIn adults with active lupus, repository corticotropin gel reduced swollen and tender joint counts from baseline to week 16.
Peptide
ACTH (corticotropin)
Outcome
Decrease28 SJC/TJC at week 16
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609602
06HumanNon-randomized trialEfficacy outcome
In adults with active SLE, repository corticotropin gel reduced CLASI-Activity score from baseline to week 16.
In plain wordsIn adults with active lupus, repository corticotropin gel reduced skin disease activity from baseline to week 16.
Peptide
ACTH (corticotropin)
Outcome
DecreaseCLASI-Activity score at week 16
Study
n: not reported in source
Comparator
Baseline
Outcome group
Skin and hair · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609603
07HumanNon-randomized trialMechanism
In adults with active SLE, repository corticotropin gel reduced BAFF from baseline to week 8, with cytokine identity corrected by notice.
In plain wordsIn adults with active lupus, repository corticotropin gel reduced BAFF from baseline to week 8, according to the correction.
Peptide
ACTH (corticotropin)
Outcome
DecreaseBAFF change from baseline at week 8
Study
n: not reported in source
Comparator
Baseline
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609604
08HumanNon-randomized trialSafety outcome
In adults with active SLE, the repository corticotropin gel trial identified no new safety signals.
In plain wordsIn adults with active lupus, the repository corticotropin gel trial identified no new safety signals.
Peptide
ACTH (corticotropin)
Outcome
Direction not reportedNew safety signals
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
No new safety signals were identified.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609609
09HumanObservational studyEfficacy outcome
Post hoc analysis found greater SRI-4 response in repository corticotropin gel recipients with baseline SLEDAI-2000 ≥ 10 and CLASI-Activity ≥ 11.
In plain wordsPost hoc analysis found greater SRI-4 response among repository corticotropin gel recipients with higher baseline lupus and skin activity scores.
Peptide
ACTH (corticotropin)
Outcome
IncreaseSRI-4 response in baseline disease-activity subgroups
Study
n: not reported in source
Outcome group
Immune response · Immune and inflammation
Studied dose
80 U every other day to week 4, then twice weekly to week 24 · subcutaneousAs given in this study (human).
Source sentences
Summary
Post hoc analyses demonstrated a greater proportion of BILAG-based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 ≥ 10 and CLASI-Activity ≥ 11.
3 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
Summary · context
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 w…
Summary · context
Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24.
Report a problemFND-3299609608

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT02953821

Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Mallinckrodtn = 17216 Dec 2016 to 25 Oct 2019

Lupus Erythematosus, Systemic

Trial page ClinicalTrials.govUpdated 20 Aug 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated · status corrected
Version 1
27 Oct 2026, 16:35 UTC
First added · status corrected · source update from Europe PMC