Evidence map›Paper›PMID 26120075›Full record

Trial reportJournal of clinical pharmacology2016

Pharmacodynamics and tolerability of repository corticotropin injection in healthy human subjects: A comparison with intravenous methylprednisolone.

Ritu Lal, Stacie Bell, Rashida Challenger, Vakessa Hammock, Mary Nyberg, Dima Decker, Patrice M Becker, David Young

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Article
  7. Retrospective Medical Record Review to Describe Use of Repository Corticotropin Injection Among Patients with Uveitis in the United States.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2019
    Article
  8. Article
  9. Observational
  10. Review
  11. Article
  12. 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

8 authors at 1 institution in 1 country.

Ritu LalMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
Stacie BellMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
Rashida ChallengerMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
Vakessa HammockMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
Mary NybergMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
Dima DeckerMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
Patrice M BeckerMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
David YoungMallinckrodt Pharmaceuticals, Ellicott City, MD, USA.
Mallinckrodt (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Repository corticotropin injection (porcine adrenocorticotropic hormone [ACTH] analog) and intravenous methylprednisolone (IVMP) are used to treat inflammatory conditions such as multiple sclerosis (MS) exacerbations and rheumatoid arthritis. This multiple-dose, randomized, crossover, open-label study evaluated and compared pharmacodynamic outcomes in subjects who received ACTH analog (80 U subcutaneously) or IVMP (1 g) daily for 5 days. Specific outcome measures included IVMP and cortisol concentrations, total cortisol-equivalent exposure, immune cell population changes, and tolerability. IVMP and ACTH analog increased granulocyte numbers and decreased lymphocyte counts; effects on both were significantly less pronounced with ACTH analog. Based on total cortisol-equivalent exposure (assuming linearity), administration of 80 U of ACTH analog equates to 30 mg IVMP. Because IVMP doses significantly higher than 30 mg are usually required to treat MS exacerbations, the lower cortisol-equivalent exposure of 80 U ACTH analog supports the hypothesis that efficacy of ACTH analog results from both steroid-dependent and -independent properties. Adverse events were mild in severity; subject incidence for adverse-event reporting was similar following both regimens. The clinical relevance of these findings in autoimmune disease populations is unknown and requires further evaluation.

Indexed as

Adrenocorticotropic HormoneAdultCross-Over StudiesHumansHydrocortisoneInjections, IntravenousLeukocyte CountLeukocytesMethylprednisoloneYoung AdultAdrenocorticotropic HormoneHydrocortisoneMethylprednisolonebiomarkersclinical pharmacologyclinical researchpharmacodynamicspharmacology

Identifiers

PMID26120075
PMCPMC5049675
OpenAlexW2141387431

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.