Efficacy and tolerability of repository corticotropin injection in patients with persistently active SLE: results of a phase 4, randomised, controlled pilot study.

Furie R, Mitrane M, Zhao E, Das M, Li D, Becker PM

Lupus science & medicine21 Oct 2016Cited by 31 (Europe PMC)

PMID27933199PMCIDPMC5133412DOI10.1136/lupus-2016-000180PepBankPUB-27933199

Summary

ObjectiveTo evaluate the efficacy of a prolonged-release formulation of a porcine adrenocorticotropic hormone analogue (repository corticotropin injection (RCI)) added to standard of care in patients requiring moderate-dose corticosteroids for symptomatic SLE.MethodsThis prospective, randomised, double-blind, phase 4, pilot study (NCT01753401) enrolled 38 patients with persistently active SLE involving skin and/or joints. Enrolled patients received RCI, 40 U daily or 80 U every other day, or volume-matched placebo gel, for 8 weeks, with dose tapering to twice weekly during weeks 5-8. Efficacy endpoints included proportion of responders at week 4 based on a novel composite measure that included resolution of rash or arthritis measured using the hybrid SLE Disease Activity Index (hSLEDAI) without worsening British Isles Lupus Assessment Group (BILAG) scores in other organ systems at week 4 (primary), as well as improvements in total hSLEDAI and BILAG scores and other measures of skin and joint disease activity over the 8-week treatment period.ResultsResponse, as defined for the primary endpoint, did not differ significantly between the combined placebo and RCI-treated groups at week 4. At week 8, the proportion of responders was higher in RCI-treated patients but did not statistically differ between groups (RCI 40 U (53.8%), RCI 80 U (33.3%), combined placebo (27.3%)). However, RCI treatment was associated with statistically significant improvements in several secondary endpoints, including total hSLEDAI, total BILAG and Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity scores within 8 weeks. Treatment was well tolerated.ConclusionsAlthough the primary endpoint was not met in this pilot study, secondary and post hoc analyses suggested that RCI was associated with improvements in SLE disease activity in a select patient population with steroid-dependent persistent disease.Trial registration numberNCT01753401; results.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In persistently active SLE, primary response at week 4 did not differ significantly between pooled RCI-treated patients and combined placebo.
In plain wordsIn persistently active SLE, response at week 4 did not differ significantly between RCI and placebo.
Peptide
ACTH (corticotropin)
Outcome
No significant changePrimary response at week 4
Study
n = 38
Comparator
Combined placebo
Analysis
Primary
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily or 80 U every other day, tapered to twice weekly during weeks 5-8 · 8 weeksAs given in this study (human).
Source sentences
Summary
Response, as defined for the primary endpoint, did not differ significantly between the combined placebo and RCI-treated groups at week 4.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy of a prolonged-release formulation of a porcine adrenocorticotropic hormone analogue (repository corticotropin injection (RCI)) added to standard of care in patients requiring moderate-dose corticosteroids for symptomatic SLE.
Summary · context
This prospective, randomised, double-blind, phase 4, pilot study (NCT01753401) enrolled 38 patients with persistently active SLE involving skin and/or joints.
Summary · context
Enrolled patients received RCI, 40 U daily or 80 U every other day, or volume-matched placebo gel, for 8 weeks, with dose tapering to twice weekly during weeks 5-8.
Show in the study text Report a problemFND-2793319901
02HumanRandomized controlled trialEfficacy outcome
In persistently active SLE, week 8 response was 53.8% with RCI 40 U versus 27.3% with combined placebo, without a significant difference.
In plain wordsIn persistently active SLE, week 8 response did not differ significantly between RCI 40 U and placebo.
Peptide
ACTH (corticotropin)
Outcome
No significant changeResponse at week 8, 40 U
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily, tapered to twice weekly during weeks 5-8 · 8 weeksAs given in this study (human).
Measurements
Responders at week 8
53.8%
RCI 40 U
Responders at week 8
27.3%
combined placebo
Source sentences
Summary
At week 8, the proportion of responders was higher in RCI-treated patients but did not statistically differ between groups (RCI 40 U (53.8%), RCI 80 U (33.3%), combined placebo (27.3%)).
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy of a prolonged-release formulation of a porcine adrenocorticotropic hormone analogue (repository corticotropin injection (RCI)) added to standard of care in patients requiring moderate-dose corticosteroids for symptomatic SLE.
Summary · context
This prospective, randomised, double-blind, phase 4, pilot study (NCT01753401) enrolled 38 patients with persistently active SLE involving skin and/or joints.
Summary · context
Enrolled patients received RCI, 40 U daily or 80 U every other day, or volume-matched placebo gel, for 8 weeks, with dose tapering to twice weekly during weeks 5-8.
Show in the study text Report a problemFND-2793319902
03HumanRandomized controlled trialEfficacy outcome
In persistently active SLE, week 8 response was 33.3% with RCI 80 U versus 27.3% with combined placebo, without a significant difference.
In plain wordsIn persistently active SLE, week 8 response did not differ significantly between RCI 80 U and placebo.
Peptide
ACTH (corticotropin)
Outcome
No significant changeResponse at week 8, 80 U
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Disease activity · Immune and inflammation
Studied dose
80 U every other day, tapered to twice weekly during weeks 5-8 · 8 weeksAs given in this study (human).
Measurements
Responders at week 8
33.3%
RCI 80 U
Responders at week 8
27.3%
combined placebo
Source sentences
Summary
At week 8, the proportion of responders was higher in RCI-treated patients but did not statistically differ between groups (RCI 40 U (53.8%), RCI 80 U (33.3%), combined placebo (27.3%)).
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy of a prolonged-release formulation of a porcine adrenocorticotropic hormone analogue (repository corticotropin injection (RCI)) added to standard of care in patients requiring moderate-dose corticosteroids for symptomatic SLE.
Summary · context
This prospective, randomised, double-blind, phase 4, pilot study (NCT01753401) enrolled 38 patients with persistently active SLE involving skin and/or joints.
Summary · context
Enrolled patients received RCI, 40 U daily or 80 U every other day, or volume-matched placebo gel, for 8 weeks, with dose tapering to twice weekly during weeks 5-8.
Show in the study text Report a problemFND-2793319903
04HumanNon-randomized trialEfficacy outcome
In persistently active SLE, RCI treatment was associated with statistically significant improvements in total hSLEDAI, total BILAG and Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity scores within 8 weeks.
In plain wordsIn persistently active SLE, RCI treatment was linked to significantly better secondary disease activity scores within 8 weeks.
Peptide
ACTH (corticotropin)
Outcome
DecreaseSecondary disease activity scores
Study
n: not reported in source
Analysis
Secondary
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily or 80 U every other day, tapered to twice weekly during weeks 5-8 · 8 weeksAs given in this study (human).
Source sentences
Summary
However, RCI treatment was associated with statistically significant improvements in several secondary endpoints, including total hSLEDAI, total BILAG and Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity scores within 8 weeks.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy of a prolonged-release formulation of a porcine adrenocorticotropic hormone analogue (repository corticotropin injection (RCI)) added to standard of care in patients requiring moderate-dose corticosteroids for symptomatic SLE.
Summary · context
This prospective, randomised, double-blind, phase 4, pilot study (NCT01753401) enrolled 38 patients with persistently active SLE involving skin and/or joints.
Summary · context
Enrolled patients received RCI, 40 U daily or 80 U every other day, or volume-matched placebo gel, for 8 weeks, with dose tapering to twice weekly during weeks 5-8.
Show in the study text Report a problemFND-2793319904
05HumanNon-randomized trialSafety outcome
In persistently active SLE, repository corticotropin treatment was well tolerated.
In plain wordsIn persistently active SLE, repository corticotropin treatment was well tolerated.
Peptide
ACTH (corticotropin)
Outcome
Not applicableTolerability
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
40 U daily or 80 U every other day, tapered to twice weekly during weeks 5-8 · 8 weeksAs given in this study (human).
Source sentences
Summary
Treatment was well tolerated.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy of a prolonged-release formulation of a porcine adrenocorticotropic hormone analogue (repository corticotropin injection (RCI)) added to standard of care in patients requiring moderate-dose corticosteroids for symptomatic SLE.
Summary · context
This prospective, randomised, double-blind, phase 4, pilot study (NCT01753401) enrolled 38 patients with persistently active SLE involving skin and/or joints.
Summary · context
Enrolled patients received RCI, 40 U daily or 80 U every other day, or volume-matched placebo gel, for 8 weeks, with dose tapering to twice weekly during weeks 5-8.
Show in the study text Report a problemFND-2793319905

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

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
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Keywords

PepBank is a research reference. Talk to a doctor before you use any peptide.