Evidence map›Paper›PMID 33687687›Full record

ArticleRheumatology and therapy2021

Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar

Anca D Askanase, George J Wan, Mary P Panaccio, Enxu Zhao, Julie Zhu, Roman Bilyk, Richard A Furie

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02953821 (A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02953821 phase4completednot on this map

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids

TypeinterventionalSponsorMallinckrodtRan2016 to 2019Enrolled172ConditionsLupus Erythematosus, SystemicArmsActhar Gel, Placebo Gel
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. ActharClinical drug investigation · 2023
    Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Anca D AskanaseColumbia University Irving Medical Center, New York, NY, USA. ada20@cumc.columbia.edu.
George J WanMallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Mary P PanaccioMallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Enxu ZhaoMallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Julie ZhuMallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Roman BilykMallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Richard A FurieZucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
Mallinckrodt (United States) · USColumbia University Irving Medical Center · USHofstra University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe assessed patient-reported outcomes from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar

methodsThe trial enrolled adults with active SLE and moderate-to-severe rash and/or arthritis despite use of stable glucocorticoids (7.5 mg/day to 30 mg/day prednisone equivalent), antimalarials, and nonsteroidal anti-inflammatory drugs for ≥ 4 weeks and/or immunosuppressants for ≥ 8 weeks before screening. Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day through week 4, then twice weekly through week 24. Primary analyses evaluated the change from baseline to week 24 in the Lupus Quality of Life (QoL) and Work Productivity and Activity Impairment (WPAI)-Lupus questionnaires. Post hoc analyses stratified results by baseline disease activity (SLE Disease Activity Index-2000 [SLEDAI-2K] < 10 or ≥ 10; Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI]-Activity < 11 or ≥ 11; and British Isles Lupus Assessment Group [BILAG]-2004 < 20 or ≥ 20) and by BILAG-based Combined Lupus Assessment (BICLA) response at weeks 20 and 24.

resultsRCI treatment resulted in greater improvement in the LupusQoL pain domain at week 16 and planning domain at week 24 compared with placebo. Post hoc analyses demonstrated greater improvements with RCI in the pain, planning, and fatigue domains than with placebo at multiple time points in patients with higher disease activity by baseline SLEDAI-2K ≥ 10, CLASI-Activity ≥ 11, and BILAG-2004 ≥ 20 and/or in BICLA responders. Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders.

conclusionsRCI may improve QoL and work productivity in patients who have persistently active SLE despite treatment with standard SLE therapy.

trial registrationClinicalTrials.gov identifier NCT02953821.

Indexed as

Acthar GelAutoimmune diseaseGlucocorticoidPatient-reported outcomesRepository corticotropin injectionSystemic lupus erythematosus

Identifiers

PMID33687687
PMCPMC7991053
OpenAlexW3135181020

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.