Evidence map›Paper›PMID 35184268›Full record

ArticleRheumatology and therapy2022

Post Hoc Analysis of Predictors of Clinical Response to Repository Corticotropin Injection in Persistently Active Rheumatoid Arthritis.

Roy Fleischmann, Kyle Hayes, Sung-Woo Ahn, George J Wan, Mary Panaccio, Daniel Karlsson, Daniel E Furst

Open access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 53% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. ActharClinical drug investigation · 2023
    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.

Roy FleischmannUniversity of Texas Southwestern Medical Center, Metroplex Clinical Research Center, 8144 Walnut Hill Lane, Dallas, TX, 75231, USA. rfleischmann@arthdocs.com.ORCID http://orcid.org/0000-0002-6630-1477
Kyle HayesMallinckrodt Pharmaceuticals, Hampton, NJ, USA.ORCID http://orcid.org/0000-0001-8203-4738
Sung-Woo AhnKMK Consulting Inc., Morristown, NJ, USA.
George J WanMallinckrodt Pharmaceuticals, Hampton, NJ, USA.ORCID http://orcid.org/0000-0002-1140-740X
Mary PanaccioMallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Daniel KarlssonMallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Daniel E FurstDavid Geffen School of Medicine, Division of Rheumatology, University of California, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0002-4018-7629
Mallinckrodt (United States) · USMetroplex Clinical Research Center · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA phase IV clinical trial confirmed the safety and efficacy of repository corticotropin injection (RCI, Acthar

methodsThe phase IV trial was a two-part, randomized, placebo-controlled withdrawal study. Post hoc analysis was conducted with the open-label portion of the trial data, in which all 258 subjects received RCI (80 U) twice weekly for 12 weeks. Responders were subjects who achieved low disease activity (LDA) by a Disease Activity Score with 28-joint count and erythrocyte sedimentation rate (DAS28-ESR) of < 3.2 at week 12. Responders were compared with nonresponders by assessing the proportion of subjects in each group for demographics and clinical characteristics, including weight, disease duration, medical history including osteoarthritis and unrelated joint conditions, hemoglobin A1c, C-reactive protein, ESR, DAS28-ESR, Clinical Disease Activity Index (CDAI), depression, anxiety, tender joint count (TJC), and swollen joint count (SJC). Bivariate analysis followed by multiple logistic regression analysis were conducted to identify significant baseline predictors for the outcome of achieving LDA by week 12.

resultsBivariate analysis showed that RCI responders had significantly lower baseline TJC (p = 0.0310), SJC (p = 0.0018), ESR (p = 0.0487), and CDAI (p = 0.0112) and shorter RA disease duration (p = 0.0446). Subjects were less likely to achieve LDA if they had osteoarthritis (p < 0.0001), other joint-related conditions unrelated to RA (p < 0.0001), anemia (p = 0.0132), depression (p = 0.0006), or prior or concomitant use of targeted-synthetic or biologic disease-modifying antirheumatic drugs (p < 0.0001). Multiple logistic regression analysis revealed that, of the above, only ongoing osteoarthritis (p = 0.0272) or other joint-related conditions (p = 0.0193) were significant negative predictors of RCI response.

conclusionsThese results identify specific patient characteristics that may be considered predictors of positive or negative clinical response to RCI.

Indexed as

Acthar GelLow disease activityRCIRepository corticotropin injectionRespondersRheumatoid arthritis

Identifiers

PMID35184268
PMCPMC8964897
OpenAlexW4212822641

What OpenQuestion holds

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Registered trials

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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.