Evidence map›Paper›PMID 33523513›Full record

Trial reportThe Journal of dermatology2021

Long-term efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 5-year extension of a phase 3 study (reSURFACE 1).

Shinichi Imafuku, Hidemi Nakagawa, Atsuyuki Igarashi, Akimichi Morita, Yukari Okubo, Shigetoshi Sano, Yayoi Tada, Osamu Nemoto, Stephen J Rozzo, Masaki Kawamura and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01722331 (A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 35% 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.

NCT01722331 phase3completednot on this map

A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)

TypeinterventionalSponsorSun Pharmaceutical Industries LimitedRan2012 to 2021Enrolled772ConditionsPlaque PsoriasisArmsTildrakizumab 200 mg, Tildrakizumab 100 mg, Matching Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. 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

11 authors at 10 institutions in 2 countries.

Shinichi ImafukuFukuoka University, Fukuoka, Japan.ORCID https://orcid.org/0000-0001-8568-4349
Hidemi NakagawaThe Jikei University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0002-8272-4488
Atsuyuki IgarashiNTT Medical Center Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0002-5903-3187
Akimichi MoritaNagoya City University, Nagoya City, Japan.ORCID https://orcid.org/0000-0001-8372-3754
Yukari OkuboTokyo Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9526-1259
Shigetoshi SanoKochi University, Kochi, Japan.ORCID https://orcid.org/0000-0002-9812-0216
Yayoi TadaTeikyo University, Tokyo, Japan.ORCID https://orcid.org/0000-0003-3743-135X
Osamu NemotoKojinkai Sapporo Skin Clinic, Hokkaido, Japan.
Stephen J RozzoSun Pharmaceutical Industries, Inc, Princeton, NJ, USA.
Masaki KawamuraSun Pharma Japan Ltd, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1467-6875
Mamitaro OhtsukiJichi Medical University, Tochigi, Japan.
Fukuoka University · JPJichi Medical University · JPJikei University School of Medicine · JPKōchi University · JPNagoya City University · JPNTT Medical Center · JPSun Pharma (Japan) · JPSun Pharma (United States) · USTeikyo University Hospital · JPTokyo Medical University · JP

Funding

Merck Sharp and DohmeSun Pharmaceutical Industries, Inc.
6 · The paper itself

Abstract

The three part, double-blind, randomized, controlled reSURFACE 1 trial and extension study (NCT01722331) evaluated efficacy and safety of tildrakizumab in adults with moderate to severe plaque psoriasis. Patients with ≥50% improvement from baseline in Psoriasis Area and Severity Index (PASI 50) following treatment with tildrakizumab 100 mg (TIL100) or 200 mg (TIL200) could enter the optional long-term extension study and continue treatment at the same dose for an additional 192 weeks. This subgroup analysis assessed the long-term efficacy and safety of tildrakizumab treatment for Japanese patients enrolled in reSURFACE 1 for up to 5 years of treatment. The primary efficacy outcomes were the proportions of patients who maintained PASI 75 and Physician Global Assessment (PGA) clear or minimal with ≥2-grade reduction from baseline (PGA 0/1) from base study week 64 to extension week 192. Secondary outcomes were the proportion of patients who maintained PASI 90/100 from base study week 64 to extension week 192. Adverse events (AEs) were monitored throughout the study and for up to 20 weeks after the last study visit. Of the 120 Japanese patients who entered the reSURFACE 1 extension study, 43 (79.6%) patients receiving tildrakizumab 100 mg and 58 (87.9%) patients receiving tildrakizumab 200 mg completed the extension study. Of all Japanese patients with PASI 75/90/100 and PGA 0/1 at week 64, 85%/88% receiving TIL100/TIL200 maintained PASI 75, 70%/96% maintained PASI 90, 63%/67% maintained PASI 100, and 68%/72% maintained PGA 0/1 at extension week 192. AEs led to discontinuation in 1.7 patients per 100 patient-years (P100PY) receiving tildrakizumab 100 mg and 0.8 P100PY receiving tildrakizumab 200 mg. Incidences of severe infections, malignancies, confirmed major adverse cardiac events, and hypersensitivity reactions were low in both treatment groups. Through 5 years of treatment, tildrakizumab maintained efficacy and was well tolerated with low rates of AEs of special interest.

Indexed as

PsoriasisAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansJapanSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizedtildrakizumabbiologic therapyIL-23p19psoriasisPsoriasis Area and Severity Indextildrakizumab

Identifiers

PMID33523513
PMCPMC8248015
OpenAlexW3128320066

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.