Evidence map›Paper›PMID 28148280›Full record

Trial reportTrials2017

Optimizing adalimumab treatment in psoriasis with concomitant methotrexate (OPTIMAP): study protocol for a pragmatic, single-blinded, investigator-initiated randomized controlled trial.

C I Busard, S P Menting, J S van Bezooijen, J M van den Reek, B A Hutten, E P Prens, E M de Jong, M B van Doorn, P I Spuls

Erratum issuedOpen access · goldAbstract readComparative StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 5 pooled it
1.2field-weighted citation impact, top 23% 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

8 citing papers in PubMed, 5 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Review
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

C I BusardDepartment of Dermatology, Academic Medical Center, Amsterdam, The Netherlands. c.i.busard@amc.uva.nl.
S P MentingDepartment of Dermatology, Academic Medical Center, Amsterdam, The Netherlands.
J S van BezooijenDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
J M van den ReekDepartment of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.
B A HuttenDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands.
E P PrensDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
E M de JongDepartment of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.
M B van DoornDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
P I SpulsDepartment of Dermatology, Academic Medical Center, Amsterdam, The Netherlands.
Academic Medical Center · NLErasmus MC · NLRadboud University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases.

methodsThis is an investigator-initiated, multicenter randomized controlled trial (RCT) designed to compare the combination treatment of adalimumab and methotrexate with adalimumab monotherapy in patients with psoriasis. The primary outcome is adalimumab drug survival at week 49. Other outcomes include improvement in disease severity and quality of life, tolerability, and safety. Moreover, anti-adalimumab antibodies and adalimumab serum concentrations will be measured and correlations between genotypes and clinical outcomes will be assessed. Patient recruitment started in March 2014. Up to now, 36 patients have been randomized. Many more patients have been (pre)screened. A total of 93 patients is desired to meet an adequate sample size. In our experience, the main limitation for recruitment is prior adalimumab therapy and intolerability or toxicity for methotrexate in the past. DISCUSSION: OPTIMAP is the first RCT to examine combination therapy with adalimumab and methotrexate in a psoriasis population. With data derived from this study we expect to provide valuable clinical data on long-term treatment outcomes. These data will be supported by assessment of the impact of concomitant methotrexate on adalimumab pharmacokinetics. Furthermore, the influence of several single nucleotide polymorphisms on adalimumab response will be analyzed in order to support the development of a more personalized approach for this targeted therapy.

trial registrationNTR4499 . Registered on 7 April 2014.

Indexed as

AdalimumabBiological ProductsClinical ProtocolsDrug Therapy, CombinationHumansImmunosuppressive AgentsMethotrexateNetherlandsPsoriasisQuality of LifeRemission InductionResearch DesignSeverity of Illness IndexSingle-Blind MethodSkinTime FactorsAdalimumabBiological ProductsImmunosuppressive AgentsMethotrexateTumor Necrosis Factor-alphaCombination therapyMulticenterPragmaticPsoriasisRandomized controlled trial

Identifiers

PMID28148280
PMCPMC5288945
OpenAlexW2583618545

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.