Evidence map›Paper›PMID 34060012›Full record

ArticleDermatology and therapy2021

Efficacy and Safety of Netakimab, A Novel Anti-IL-17 Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis. Results of A 54-Week Randomized Double-Blind Placebo-Controlled PLANETA Clinical Trial.

Luís Puig, Andrey L Bakulev, Muza M Kokhan, Alexey V Samtsov, Vladislav R Khairutdinov, Maria A Morozova, Nikita A Zolkin, Ivan V Kuryshev, Alexey N Petrov, Antonina V Artemeva and 1 more

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

Article in Dermatology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03390101 (An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085), which is not on this map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT03390101 phase3completednot on this map

An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis

TypeinterventionalSponsorBiocadRan2017 to 2022Enrolled213ConditionsModerate to Severe Plaque PsoriasisArmsBCD-085 Q2W, BCD-085 Q4W, Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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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

11 authors at 5 institutions in 2 countries.

Luís PuigDepartment of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Andrey L BakulevSaratov State Medical University, Saratov, Russia.
Muza M KokhanUral Research Institute of Dermatovenerology and Immunopathology, Yekaterinburg, Russia.
Alexey V SamtsovS. M. Kirov Military Medical Academy, St-Petersburg, Russia.
Vladislav R KhairutdinovS. M. Kirov Military Medical Academy, St-Petersburg, Russia.
Maria A MorozovaJSC BIOCAD, St-Petersburg, Russia. morozovama@biocad.ru.ORCID http://orcid.org/0000-0001-7755-7526
Nikita A ZolkinJSC BIOCAD, St-Petersburg, Russia.
Ivan V KuryshevJSC BIOCAD, St-Petersburg, Russia.
Alexey N PetrovJSC BIOCAD, St-Petersburg, Russia.
Antonina V ArtemevaJSC BIOCAD, St-Petersburg, Russia.
Arina V Zinkina-OrikhanJSC BIOCAD, St-Petersburg, Russia.
BIOCAD (Russia) · RUS. M. Kirov Military Medical Academy · RUHospital de Sant Pau · ESSaratov State Medical University · RUUral Scientific Research Institute of Dermatovenerology and Immunopathology · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNetakimab (NTK), an original humanized anti-interleukin-17 monoclonal antibody, showed therapeutic efficacy in moderate-to-severe plaque psoriasis in a phase 2 clinical study. Herein we report the results of 54 weeks of a phase 3 PLANETA trial aimed to evaluate the efficacy and safety of two NTK regimens vs. placebo.

methodsTwo hundred thirteen patients with moderate-to-severe plaque psoriasis were randomly assigned to receive NTK 120 mg once every 2 weeks (NTK Q2W), NTK 120 mg once every 4 weeks (NTK Q4W) or placebo. During the first 3 weeks, patients received subcutaneous injections of NTK or placebo (according to the allocation) once a week. Patients in the NTK Q2W group then received NTK at weeks 4, 6, 8 and 10. Subjects in the NTK Q4W group received NTK at weeks 6 and 10 and placebo at weeks 4 and 8. Patients in the placebo group received placebo injections at weeks 4, 6, 8 and 10. Treatment was unblinded at week 12. During the open-label phase, patients in both NTK groups continued to receive NTK Q4W. The primary efficacy endpoint was the proportion of patients in each group who achieved a ≥ 75% reduction from baseline in psoriasis area and severity index (PASI 75) at week 12.

resultsA total of 77.7%, 83.3% and 0% of patients had a PASI 75 response at week 12 in the NTK Q2W, NTK Q4W and placebo groups, respectively (P < 0.0001, Fisher's exact test, ITT). The effect was maintained throughout the 1-year treatment. NTK showed a good safety profile and low immunogenicity.

conclusionTreatment with NTK results in high rates of sustained clinical response in patients with moderate-to-severe plaque psoriasis. The study is ongoing; thus, long-term use efficacy and safety data are forthcoming. CLINICAL

trial registrationThe trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT03390101).

Indexed as

Interleukin-17 inhibitorsNetakimabPsoriasis

Identifiers

PMID34060012
PMCPMC8322379
OpenAlexW3165260160

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.