Evidence map›Paper›PMID 28391657›Full record

Trial reportThe Journal of dermatology2017

Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial.

Mamitaro Ohtsuki, Yukari Okubo, Mayumi Komine, Shinichi Imafuku, Robert M Day, Peng Chen, Rosemary Petric, Allan Maroli, Osamu Nemoto

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of dermatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01988103 (A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast), which is not on this map. Cited by 29 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 8 pooled it
–field-weighted citation impact
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.

NCT01988103 phase2completednot on this map

A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis

TypeinterventionalSponsorAmgenRan2013 to 2015Enrolled254ConditionsPsoriasis, Psoriatic Arthritis, Psoriasis ArthropaticaArmsApremilast, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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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

9 authors.

Mamitaro OhtsukiJichi Medical University, Shimotsuke, Japan.
Yukari OkuboTokyo Medical University, Tokyo, Japan.
Mayumi KomineJichi Medical University, Shimotsuke, Japan.
Shinichi ImafukuFukuoka University, Fukuoka, Japan.
Robert M DayCelgene Corporation, Summit, New Jersey, USA.
Peng ChenCelgene Corporation, Summit, New Jersey, USA.
Rosemary PetricCelgene Corporation, Summit, New Jersey, USA.
Allan MaroliCelgene Corporation, Summit, New Jersey, USA.
Osamu NemotoKojinkai Sapporo Skin Clinic, Sapporo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, works intracellularly within immune cells to regulate inflammatory mediators. This phase 2b randomized, placebo-controlled study evaluated efficacy and safety of apremilast among Japanese patients with moderate to severe plaque psoriasis. In total, 254 patients were randomized to placebo, apremilast 20 mg b.i.d. (apremilast 20) or apremilast 30 mg b.i.d. (apremilast 30) through week 16; thereafter, all placebo patients were re-randomized to apremilast 20 or 30 through week 68. Efficacy assessments included achievement of 75% or more reduction from baseline in Psoriasis Area and Severity Index score (PASI-75; primary) and achievement of static Physician Global Assessment (sPGA; secondary) score of 0 (clear) or 1 (minimal) at week 16. Safety was assessed through week 68. At week 16, PASI-75 response rates were 7.1% (placebo), 23.5% (apremilast 20; P = 0.0032 vs placebo) and 28.2% (apremilast 30; P = 0.0003 vs placebo); sPGA response rates (score of 0 or 1) were 8.8% (placebo), 23.9% (apremilast 20; P = 0.0165 vs placebo) and 29.6% (apremilast 30; P = 0.0020 vs placebo). Responses were maintained with apremilast through week 68. Most common adverse events (AEs) with placebo, apremilast 20 and apremilast 30 (0-16 weeks) were nasopharyngitis (8.3%, 11.8%, 11.8%), diarrhea (1.2%, 8.2%, 9.4%), and abdominal discomfort (1.2%, 1.2%, 7.1%), respectively. Exposure-adjusted incidence of these AEs did not increase with continued apremilast treatment (up to 68 weeks). Apremilast demonstrated efficacy and safety in Japanese patients with moderate to severe plaque psoriasis through 68 weeks that was generally consistent with prior studies.

Indexed as

Administration, OralAdultAnti-Inflammatory Agents, Non-SteroidalDiarrheaDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansIncidenceJapanMaleMiddle AgedNasopharyngitisPhosphodiesterase 4 InhibitorsPlacebosPsoriasisAnti-Inflammatory Agents, Non-SteroidalapremilastPhosphodiesterase 4 InhibitorsPlacebosThalidomideapremilastphosphodiesterase 4phosphodiesterase 4 inhibitorpsoriasisPsoriasis Area and Severity Index

Identifiers

PMID28391657
PMCPMC5573969

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.