Evidence map›Paper›PMID 33712987›Full record

Trial reportAmerican journal of clinical dermatology2021

Comparison of the Efficacy and Safety of Apremilast and Methotrexate in Patients with Palmoplantar Psoriasis: A Randomized Controlled Trial.

Soufila Kt, Vishal Thakur, Tarun Narang, Sunil Dogra, Sanjeev Handa

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in American journal of clinical dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 31% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. 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

5 authors at 1 institution in 1 country.

Soufila KtDepartment of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.
Vishal ThakurDepartment of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.
Tarun NarangDepartment of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India. narangtarun@yahoo.co.in.ORCID http://orcid.org/0000-0002-0464-2989
Sunil DograDepartment of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.
Sanjeev HandaDepartment of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.
Post Graduate Institute of Medical Education and Research · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlacebo-controlled studies have reported the efficacy of apremilast in the management of palmoplantar psoriasis but studies comparing efficacy with a conventional agent are lacking.

objectiveThe objective of this article was to  compare the efficacy and safety of apremilast and methotrexate in patients with palmoplantar psoriasis.

methodsIn this prospective, randomized, active-controlled, observer-blinded clinical trial, conducted at a psoriasis clinic of a tertiary care institute in India from 1 July, 2019 to 1 June, 2020, 84 patients with palmoplantar psoriasis were randomized (1:1) to receive either methotrexate (0.4 mg/kg/week orally) or apremilast (30 mg twice daily). The treatment protocol was continued for 16 weeks or until achieving a ≥ 75% improvement in the Modified Palmoplantar Psoriasis Area and Severity Index (m-PPPASI 75), whichever was earlier. Changes in m-PPPASI and Dermatology Life Quality Index scores from baseline, the proportion of patients achieving m-PPPASI 75, and adverse events were assessed.

resultsEighty-four patients were included (76 palmoplantar psoriasis and 8 palmoplantar pustulosis). The mean age (standard deviation) was 44.5 (12.9) years and 53 (63%) were women. The m-PPPASI score [median (interquartile range)] after 16 weeks of treatment showed a significant improvement from baseline in both apremilast [- 6.3 (10.9), p < 0.001] and methotrexate groups [- 8.5 (9.9), p < 0.001]. The estimated median difference between the groups was - 1.2 (p = 0.39, 95% confidence interval - 4.2 to 2.1). At 16 weeks, m-PPPASI 75 was achieved by 14/42 (33%) and 17/42 (41%) patients in the apremilast and methotrexate groups, respectively (p = 0.49). A significant reduction in the Dermatology Life Quality Index score [median (interquartile range)] was observed in both groups [apremilast: - 3.0 (6.0), p < 0.001; methotrexate: - 3.0 (6.3), p < 0.001] with an estimated median difference of 0.0 (p = 0.99, 95% confidence interval - 1.0 to 2.0). The proportion of patients experiencing adverse events was comparable (p = 0.49).

conclusionsApremilast showed a comparable efficacy and safety profile to methotrexate in the management of palmoplantar psoriasis. CLINICAL

trial registrationCTRI/2019/06/019830, date of registration: 24 June, 2019; trial registered prospectively.

Indexed as

AdultDermatologic AgentsFemaleHumansMaleMethotrexateMiddle AgedProspective StudiesPsoriasisSeverity of Illness IndexThalidomideTreatment OutcomeapremilastDermatologic AgentsMethotrexateThalidomide

Identifiers

PMID33712987
OpenAlexW3135802193

What OpenQuestion holds

Textmetadata
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.