Efficacy and Safety of Tildrakizumab for Plaque Psoriasis with Continuous Dosing, Treatment Interruption, Dose Adjustments and Switching from Etanercept: Results from Phase III Studies

Overview

Journal Br J Dermatol

Publisher Oxford University Press

Specialty Dermatology

Date 2019 Sep 6

PMID 31487406

Citations 10

Authors

A B Kimball

K A Papp

K Reich

M Gooderham

Q Li

N Cichanowitz

C La Rosa

A Blauvelt

Affiliations

Soon will be listed here.

Abstract

Background: Chronic psoriasis may require medication adjustments over time.

Objectives: To evaluate the efficacy/safety of tildrakizumab in subgroups from the reSURFACE studies (N = 1862) that received continuous dosing, higher/lower dosing, treatment interruption/reinitiation and initiation.

Methods: Responders [Psoriasis Area and Severity Index (PASI) ≥ 75%] and partial responders (PASI ≥ 50% to < 75%) in Part 3 of the reSURFACE studies (weeks 28-52 or week 64) who received tildrakizumab 200 mg or 100 mg were rerandomized to the same dosage (T100/T100 or T200/T200), a higher/lower dosage (T100/T200 or T200/T100) or placebo (PBO) (T100/PBO or T200/PBO). Patients receiving PBO who relapsed were reinitiated to tildrakizumab. Etanercept (ETN) week-28 partial responders and nonresponders (PASI < 50%) received tildrakizumab 200 mg (ETN/T200).

Results: Among T100/T100 and T200/T200 week-28 partial responders, the proportion of patients who achieved as-observed PASI 75 responses increased over time. Among T100/T200 week-28 partial responders, PASI 75 responses increased from week 32 (38·5%) to week 52 (63·2%) and remained consistent in T200/T100 week-28 responders. Among patients who relapsed in the T100/PBO and T200/PBO groups, 86% and 83% of those who reinitiated tildrakizumab achieved PASI 75 by week 64, respectively. Among ETN/T200 week-28 partial responders, PASI 75 responses (nonresponder imputation) increased from week 32 (24·1%) to week 52 (74·7%). PASI 90, PASI 100 and Physician's Global Assessment responses were consistent with PASI 75 results. Treatment was well tolerated.

Conclusions: Patients generally fared well with tildrakizumab maintenance, reinitiation, dose adjustment or initiation. What's already known about this topic? Tildrakizumab demonstrated significant efficacy vs. placebo with a positive safety profile during the first 28 weeks of treatment in two randomized double-blind trials. What does this study add? Treatment scenarios with tildrakizumab, such as long-term continuous dosing (up to 64 weeks), treatment interruption/reinitiation and switching from another biologic, can be part of the management of plaque psoriasis with a reasonable expectation of efficacy and tolerability.

Citing Articles

Uncovering the Differences: How DLQI and WHO-5 Scores Vary in Moderate-to-Severe Psoriasis Patients Treated with Tildrakizumab 100 mg vs. 200 mg?.

Trovato E, Dragotto M, Capalbo E, Cartocci A, Rubegni P, Calabrese L J Clin Med. 2024; 13(17).

PMID: 39274452 PMC: 11396214. DOI: 10.3390/jcm13175240.

Safety of tildrakizumab: a disproportionality analysis based on the FDA adverse event reporting system (FAERS) database from 2018-2023.

Lin J, Chen X, Luo M, Zhuo Q, Zhang H, Chen N Front Pharmacol. 2024; 15:1420478.

PMID: 39050749 PMC: 11267582. DOI: 10.3389/fphar.2024.1420478.

Anti-IL23 biologic therapies in the treatment of psoriasis: real-world experience versus clinical trials data.

Ruggiero A, Megna M, Fabbrocini G, Ocampo-Garza S Immunol Res. 2023; 71(3):328-355.

PMID: 36598647 PMC: 9811885. DOI: 10.1007/s12026-022-09356-y.

The Relapse of Psoriasis: Mechanisms and Mysteries.

Tian D, Lai Y JID Innov. 2022; 2(3):100116.

PMID: 35601055 PMC: 9121322. DOI: 10.1016/j.xjidi.2022.100116.

Time to Relapse After Discontinuing Systemic Treatment for Psoriasis: A Systematic Review.

Regnault M, Shourick J, Jendoubi F, Tauber M, Paul C Am J Clin Dermatol. 2022; 23(4):433-447.

PMID: 35489008 PMC: 9055370. DOI: 10.1007/s40257-022-00679-y.

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