Repository corticotropin injection in patients with persistently active SLE requiring corticosteroids: post hoc analysis of results from a two-part, 52-week pilot study.

Furie RA, Mitrane M, Zhao E, Becker PM

Lupus science & medicine27 Dec 2017Cited by 14 (Europe PMC)

PMID29344387PMCIDPMC5761300DOI10.1136/lupus-2017-000240PepBankPUB-29344387

Summary

ObjectivePost hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.MethodsPatients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period. Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52. Outcomes included proportion of responders based on a novel index (resolution of joint or skin activity using hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) without any worsening British Isles Lupus Assessment Group (BILAG) scores in other organ systems) or revised novel index (using SLE Responder Index (SRI) definition of BILAG worsening (1A or 2B)), proportion of responders by SRI and changes in total hSLEDAI and BILAG scores. Adverse events and laboratory values were assessed.ResultsAt week 52, 12.0% (3/25) RCI/RCI patients and 36.4% (4/11) placebo/RCI patients were responders using the novel index. The revised novel responder index demonstrated response rates of 48.0% (12/25) and 54.5% (6/11) in the RCI/RCI and placebo/RCI groups, respectively. Proportions of SRI responders were 40.0% (10/25) and 54.5% (6/11). In the RCI/RCI group, total hSLEDAI and BILAG scores declined from 10.0 and 15.7 at week 0 to 3.5 and 4.6 at week 52, respectively. Reductions in the placebo/RCI group on switching were observed (mean hSLEDAI: 9.1-3.3; BILAG: 13.5-2.6). Other disease activity endpoints also improved in both groups. No new safety signals were observed during the OLE.ConclusionsRCI demonstrated durable effectiveness in patients with persistently active SLE despite moderate-dose corticosteroid therapy. Switching from placebo resulted in reduced disease activity during the OLE. These data provide the foundation for evaluation of RCI in a robustly powered study.

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

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanNon-randomized trialEfficacy outcome
In persistently active SLE, 12.0% (3/25) of RCI/RCI patients met the novel responder index at week 52.
In plain wordsIn persistently active SLE, 12.0% of patients who received RCI throughout met the novel response index at week 52.
Peptide
ACTH (corticotropin)
Outcome
Not applicableNovel index response, RCI/RCI
Study
n = 25
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily or 80 U every other day for 8 weeks, then 16, 40 or 80 U 1-3 times/week · 52 weeksAs given in this study (human).
Measurements
Responders by novel index
12%
RCI/RCI, week 52; 3 of 25
Responders by novel index
3 patients
RCI/RCI, week 52; 3 of 25
Source sentences
Summary
At week 52, 12.0% (3/25) RCI/RCI patients and 36.4% (4/11) placebo/RCI patients were responders using the novel index.
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438701
02HumanNon-randomized trialEfficacy outcome
In persistently active SLE, 48.0% (12/25) of RCI/RCI patients met the revised novel responder index at week 52.
In plain wordsIn persistently active SLE, 48.0% of patients who received RCI throughout met the revised novel response index.
Peptide
ACTH (corticotropin)
Outcome
Not applicableRevised novel index response, RCI/RCI
Study
n = 25
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily or 80 U every other day for 8 weeks, then 16, 40 or 80 U 1-3 times/week · 52 weeksAs given in this study (human).
Measurements
Responders by revised novel index
48%
RCI/RCI, week 52; 12 of 25
Responders by revised novel index
12 patients
RCI/RCI, week 52; 12 of 25
Source sentences
Summary
The revised novel responder index demonstrated response rates of 48.0% (12/25) and 54.5% (6/11) in the RCI/RCI and placebo/RCI groups, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438703
03HumanNon-randomized trialEfficacy outcome
In persistently active SLE, 40.0% (10/25) of RCI/RCI patients were SRI responders at week 52.
In plain wordsIn persistently active SLE, 40.0% of patients who received RCI throughout met the SRI response definition.
Peptide
ACTH (corticotropin)
Outcome
Not applicableSRI response, RCI/RCI
Study
n = 25
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily or 80 U every other day for 8 weeks, then 16, 40 or 80 U 1-3 times/week · 52 weeksAs given in this study (human).
Measurements
SRI responders
40%
RCI/RCI, week 52; 10 of 25
SRI responders
10 patients
RCI/RCI, week 52; 10 of 25
Source sentences
Summary
Proportions of SRI responders were 40.0% (10/25) and 54.5% (6/11).
4 context sentences(design, population, supporting numbers)
Summary · context
The revised novel responder index demonstrated response rates of 48.0% (12/25) and 54.5% (6/11) in the RCI/RCI and placebo/RCI groups, respectively.
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438705
04HumanNon-randomized trialEfficacy outcome
In persistently active SLE, 36.4% (4/11) of placebo/RCI patients met the novel responder index at week 52.
In plain wordsIn persistently active SLE, 36.4% of patients who switched from placebo to RCI met the novel response index at week 52.
Peptide
ACTH (corticotropin)
Outcome
Not applicableNovel index response, placebo/RCI
Study
n = 11
Outcome group
Disease activity · Immune and inflammation
Studied dose
16, 40 or 80 U 1-3 times/week · Open-label extension through week 52 after the 8-week placebo periodAs given in this study (human).
Measurements
Responders by novel index
36.4%
placebo/RCI, week 52; 4 of 11
Responders by novel index
4 patients
placebo/RCI, week 52; 4 of 11
Source sentences
Summary
At week 52, 12.0% (3/25) RCI/RCI patients and 36.4% (4/11) placebo/RCI patients were responders using the novel index.
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438702
05HumanNon-randomized trialEfficacy outcome
In persistently active SLE, 54.5% (6/11) of placebo/RCI patients met the revised novel responder index at week 52.
In plain wordsIn persistently active SLE, 54.5% of patients who switched from placebo to RCI met the revised novel response index.
Peptide
ACTH (corticotropin)
Outcome
Not applicableRevised novel index response, placebo/RCI
Study
n = 11
Outcome group
Disease activity · Immune and inflammation
Studied dose
16, 40 or 80 U 1-3 times/week · Open-label extension through week 52 after the 8-week placebo periodAs given in this study (human).
Measurements
Responders by revised novel index
54.5%
placebo/RCI, week 52; 6 of 11
Responders by revised novel index
6 patients
placebo/RCI, week 52; 6 of 11
Source sentences
Summary
The revised novel responder index demonstrated response rates of 48.0% (12/25) and 54.5% (6/11) in the RCI/RCI and placebo/RCI groups, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438704
06HumanNon-randomized trialEfficacy outcome
In persistently active SLE, 54.5% (6/11) of placebo/RCI patients were SRI responders at week 52.
In plain wordsIn persistently active SLE, 54.5% of patients who switched from placebo to RCI met the SRI response definition.
Peptide
ACTH (corticotropin)
Outcome
Not applicableSRI response, placebo/RCI
Study
n = 11
Outcome group
Disease activity · Immune and inflammation
Studied dose
16, 40 or 80 U 1-3 times/week · Open-label extension through week 52 after the 8-week placebo periodAs given in this study (human).
Measurements
SRI responders
54.5%
placebo/RCI, week 52; 6 of 11
SRI responders
6 patients
placebo/RCI, week 52; 6 of 11
Source sentences
Summary
Proportions of SRI responders were 40.0% (10/25) and 54.5% (6/11).
4 context sentences(design, population, supporting numbers)
Summary · context
The revised novel responder index demonstrated response rates of 48.0% (12/25) and 54.5% (6/11) in the RCI/RCI and placebo/RCI groups, respectively.
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438706
07HumanNon-randomized trialEfficacy outcome
In persistently active SLE, hSLEDAI declined from 10.0 at week 0 to 3.5 at week 52 in the RCI/RCI group.
In plain wordsIn persistently active SLE, disease activity scores declined during continued RCI treatment.
Peptide
ACTH (corticotropin)
Outcome
DecreasehSLEDAI, RCI/RCI
Study
n: not reported in source
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily or 80 U every other day for 8 weeks, then 16, 40 or 80 U 1-3 times/week · 52 weeksAs given in this study (human).
Measurements
Total hSLEDAI score
10 points
RCI/RCI, week 0
Total hSLEDAI score
3.5 points
RCI/RCI, week 52
Source sentences
Summary
In the RCI/RCI group, total hSLEDAI and BILAG scores declined from 10.0 and 15.7 at week 0 to 3.5 and 4.6 at week 52, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438707
08HumanNon-randomized trialEfficacy outcome
In persistently active SLE, BILAG declined from 15.7 at week 0 to 4.6 at week 52 in the RCI/RCI group.
In plain wordsIn persistently active SLE, BILAG disease activity scores declined during continued RCI treatment.
Peptide
ACTH (corticotropin)
Outcome
DecreaseBILAG, RCI/RCI
Study
n: not reported in source
Outcome group
Disease activity · Immune and inflammation
Studied dose
40 U daily or 80 U every other day for 8 weeks, then 16, 40 or 80 U 1-3 times/week · 52 weeksAs given in this study (human).
Measurements
Total BILAG score
15.7 points
RCI/RCI, week 0
Total BILAG score
4.6 points
RCI/RCI, week 52
Source sentences
Summary
In the RCI/RCI group, total hSLEDAI and BILAG scores declined from 10.0 and 15.7 at week 0 to 3.5 and 4.6 at week 52, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438708
09HumanNon-randomized trialEfficacy outcome
In persistently active SLE, mean hSLEDAI declined from 9.1 to 3.3 after switching from placebo to RCI.
In plain wordsIn persistently active SLE, disease activity scores declined after patients switched from placebo to RCI.
Peptide
ACTH (corticotropin)
Outcome
DecreasehSLEDAI, placebo/RCI
Study
n: not reported in source
Outcome group
Disease activity · Immune and inflammation
Studied dose
16, 40 or 80 U 1-3 times/week · Open-label extension through week 52 after the 8-week placebo periodAs given in this study (human).
Measurements
Mean hSLEDAI score
9.1 points
placebo/RCI, first value of the reported range
Mean hSLEDAI score
3.3 points
placebo/RCI, last value of the reported range
Source sentences
Summary
Reductions in the placebo/RCI group on switching were observed (mean hSLEDAI: 9.1-3.3; BILAG: 13.5-2.6).
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438709
10HumanNon-randomized trialEfficacy outcome
In persistently active SLE, BILAG declined from 13.5 to 2.6 after switching from placebo to RCI.
In plain wordsIn persistently active SLE, BILAG disease activity scores declined after patients switched from placebo to RCI.
Peptide
ACTH (corticotropin)
Outcome
DecreaseBILAG, placebo/RCI
Study
n: not reported in source
Outcome group
Disease activity · Immune and inflammation
Studied dose
16, 40 or 80 U 1-3 times/week · Open-label extension through week 52 after the 8-week placebo periodAs given in this study (human).
Measurements
Mean BILAG score
13.5 points
placebo/RCI, first value of the reported range
Mean BILAG score
2.6 points
placebo/RCI, last value of the reported range
Source sentences
Summary
Reductions in the placebo/RCI group on switching were observed (mean hSLEDAI: 9.1-3.3; BILAG: 13.5-2.6).
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438710
11HumanNon-randomized trialSafety outcome
In persistently active SLE, no new safety signals were observed during the open-label RCI extension.
In plain wordsIn persistently active SLE, investigators observed no new safety signals during the open-label RCI extension.
Peptide
ACTH (corticotropin)
Outcome
Direction not reportedNew safety signals during extension
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
16, 40 or 80 U 1-3 times/week · Open-label extension through week 52As given in this study (human).
Source sentences
Summary
No new safety signals were observed during the OLE.
3 context sentences(design, population, supporting numbers)
Summary · context
Post hoc analyses evaluated the effectiveness and safety of repository corticotropin injection (RCI) in patients with persistently active SLE over 52 weeks.
Summary · context
Patients were initially randomised to 40 U daily or 80 U every other day RCI (n=26) or placebo (n=12) for the 8-week double-blind period.
Summary · context
Completers entered the open-label extension (OLE; n=33) receiving 16, 40 or 80 U RCI 1-3 times/week and were followed through week 52.
Show in the study text Report a problemFND-2934438712

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.