Evidence map›Paper›PMID 27504914›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2017

Efficacy and safety of adalimumab in Chinese patients with moderate-to-severe plaque psoriasis: results from a phase 3, randomized, placebo-controlled, double-blind study.

L Cai, J Gu, J Zheng, M Zheng, G Wang, L-Y Xi, F Hao, X-M Liu, Q-N Sun, Y Wang and 10 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 21 pooled it
3.9field-weighted citation impact, top 6% 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

54 citing papers in PubMed, 21 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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  3. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
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  9. Risk ofInternational journal of clinical practice · 2022
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  11. Impact of smoking on psoriasis risk and treatment efficacy: a meta-analysis.The Journal of international medical research · 2020
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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

20 authors at 16 institutions in 2 countries.

L CaiPeking University People's Hospital, Beijing, China.
J GuShanghai Changhai Hospital, Shanghai, China.
J ZhengRuijin Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
M ZhengSecond Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.
G WangThe first Affiliated Hospital of Fourth Military Medical University, PLA (Xijing Hospital), Xi'an, China.
L-Y XiSun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
F HaoThe First Affiliated Hospital of Third Military Medical University, PLA (Southwest Hospital), Chongqing, China.
X-M LiuFirst Affiliated Hospital of Dalian Medical University, Dalian, China.
Q-N SunPeking Union Medical College Hospital, Beijing, China.
Y WangPeking University First Hospital, Beijing, China.
W LaiThe Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
H FangThe First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, China.
Y-T TuUnion Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.
Q SunQilu Hospital of Shandong University, Jinan, China.
J ChenSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.
X-H GaoThe First Hospital of China Medical University, Shenyang, China.
Y GuAbbVie Inc., North Chicago, IL, USA.
H D TeixeiraAbbVie Inc., North Chicago, IL, USA.
J-Z ZhangPeking University People's Hospital, Beijing, China.
M M OkunFort HealthCare, Fort Atkinson, WI, USA.
Peking University · CNAbbVie (United States) · USPeking Union Medical College Hospital · CNArmy Medical University · CNAtkins (United States) · USChina Medical University · CNDalian Medical University · CNFirst Affiliated Hospital Zhejiang University · CNRuijin Hospital · CNSecond Affiliated Hospital of Zhejiang University · CNSecond Military Medical University · CNSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital · CNSun Yat-sen Memorial Hospital · CNThird Affiliated Hospital of Sun Yat-sen University · CNWuhan Union Hospital · CNXijing Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase 3 trial is the first to evaluate the efficacy and safety of treatment with the systemic TNF-α inhibitor, adalimumab, for Chinese patients with moderate-to-severe plaque psoriasis.

methodsIn the 12-week, double-blind, placebo-controlled Period A, patients were randomized 4 : 1 to receive adalimumab 40 mg every-other-week (following a single 80 mg dose), or placebo every-other-week. In the subsequent 12-week, open-label, Period B, all patients received adalimumab 40 mg every-other-week starting at week 13, following a single, blinded dose at week 12 of adalimumab 80 mg or matching placebo (for patients receiving placebo or adalimumab in Period A respectively). In Period A, efficacy was analysed for all randomized patients and safety for all patients receiving ≥1 dose of the study drug.

resultsFor the 425 patients in this study (87 placebo; 338 adalimumab), a higher percentage randomized to adalimumab achieved the primary endpoint of ≥75% improvement from baseline in PASI score (PASI 75) at week 12: placebo 11.5% (10/87); adalimumab 77.8% (263/338; P < 0.001). Physician's Global Assessment of clear to minimal was achieved at week 12 by 14.9% placebo (13/87) and 80.5% adalimumab (272/338; P < 0.001). For patients who received adalimumab at any time during the study (All-adalimumab Population), treatment-emergent adverse events (AEs) were reported by 63.4%; the most common was upper respiratory infection (16.1%). Serious AEs were reported by 3.5% of the All-adalimumab Population, and serious infectious AEs by 1.2%, which include lung infection, pneumonia and tuberculosis [2 (0.5%) patients each]. There was one death (chronic heart failure).

conclusionIn these Chinese patients with moderate-to-severe psoriasis, a significantly greater percentage treated with adalimumab compared with placebo achieved efficacy endpoints at week 12 and efficacy was sustained to week 24. Safety results were consistent with the known adalimumab safety profile; no new safety signals were identified in the 24 weeks of treatment.

Indexed as

AdalimumabAdultChinaDouble-Blind MethodFemaleHumansMaleMiddle AgedPlacebosPsoriasisAdalimumabPlacebos

Identifiers

PMID27504914
PMCPMC5215651
OpenAlexW2512942811

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.