Evidence map›Paper›PMID 35622315›Full record

ArticleDermatology and therapy2022

Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis: 52-Week Results.

Yukari Okubo, Yoshinori Umezawa, Shinya Sakurai, Naoki Hoshii, Hidemi Nakagawa

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03051217 (Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT03051217 phase2 / phase3completednot on this map

Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

TypeinterventionalSponsorUCB Biopharma S.P.R.L.Ran2017 to 2019Enrolled127ConditionsModerate to Severe Psoriasis, Generalized Pustular Psoriasis and Erythrodermic PsoriasisArmsPlacebo, Certolizumab Pegol
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Use of Biological Therapies for the Management of Pustular Psoriasis: A New Era?Clinical, cosmetic and investigational dermatology · 2023
    Review
  12. Biologics for the Management of Erythrodermic Psoriasis: An Updated Review.Clinical, cosmetic and investigational dermatology · 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

5 authors at 3 institutions in 1 country.

Yukari OkuboDepartment of Dermatology, Tokyo Medical University, Tokyo, Japan.
Yoshinori UmezawaDepartment of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
Shinya SakuraiUCB Pharma, 8 Chome-17-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. Shinya.Sakurai@ucb.com.ORCID http://orcid.org/0000-0003-2631-8722
Naoki HoshiiUCB Pharma, 8 Chome-17-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.
Hidemi NakagawaDepartment of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
Jikei University School of Medicine · JPUCB Pharma (Japan) · JPTokyo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe report an exploratory analysis of the efficacy and safety of certolizumab pegol (CZP) in Japanese patients with generalized pustular psoriasis (GPP) and erythrodermic psoriasis (EP) (NCT03051217).

methodsPatients ≥ 20 years with GPP or EP were randomized 1:1 to open-label CZP 400 mg every 2 weeks (Q2W) or 200 mg Q2W (400 mg weeks 0/2/4) for 16 weeks; patients who achieved "much improved" or "very much improved" on the Global Improvement Score (GIS; for GPP) or a PASI 50 response (≥ 50% reduction from baseline Psoriasis Area and Severity Index; for EP) continued to week 52. Efficacy outcomes assessed included Clinical Global Impression of Improvement (CGI-I), Dermatology Life Quality Index (DLQI 0/1), and Itch Numeric Rating Scale (INRS 0). GIS and Japanese Dermatological Association (JDA) severity index were assessed in patients with GPP, and PASI and Physician's Global Assessment (PGA) in patients with EP. Treatment-emergent adverse events (TEAEs) were evaluated through weeks 0-52.

resultsOf 22 patients randomized, 19 completed week 52. At week 16, all reported outcomes improved with both CZP doses and were generally maintained through week 52. At week 52, 6/7 GPP and 12/12 EP patients achieved CGI-I response ("improved" or "remission"). Also, 4/7 GPP and 7/12 EP patients achieved DLQI 0/1; 2/7 GPP and 2/12 EP patients achieved INRS 0. Meanwhile, 6/7 patients with GPP achieved GIS response, and JDA severity index was reduced from baseline. We found that 9/12 and 5/12 patients with EP achieved PASI 90 and PGA 0/1, respectively. Overall, three serious TEAEs were reported in three CZP 400 mg Q2W-treated patients.

conclusionCZP treatment over 16 weeks improved the signs and symptoms of GPP and EP, and improvements were maintained through week 52. No new safety signals were identified.

trial registrationClinicalTrials.gov identifier, NCT03051217.

Indexed as

Anti-tumor necrosis factorCertolizumab pegolErythrodermic psoriasisGeneralized pustular psoriasisJapan

Identifiers

PMID35622315
PMCPMC9209588
OpenAlexW4281660150

What OpenQuestion holds

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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.