Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trial

Background Biologics for psoriasis are registered in standard dosages. In patients with low disease activity, reduction of the dose by interval prolongation can prevent overtreatment, and lower risks and costs. However, fear for increased anti-drug antibody (ADA) formation due to interval prolongati...

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Main Authors: Selma Atalay, Sophie E. Berends, Hans M. M. Groenewoud, Ron A. A. Mathot, David M. Njoo, Johannes M. Mommers, Paul M. Ossenkoppele, Marjolein I. A. Koetsier, Maartje A. Berends, Annick de Vries, Peter C. M. van de Kerkhof, Alfons A. den Broeder, Elke M. G. J. de Jong, Juul M. P. A. van den Reek
Format: Article
Language:English
Published: Taylor & Francis Group 2022-07-01
Series:Journal of Dermatological Treatment
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Online Access:https://www.tandfonline.com/doi/10.1080/09546634.2022.2043546
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author Selma Atalay
Sophie E. Berends
Hans M. M. Groenewoud
Ron A. A. Mathot
David M. Njoo
Johannes M. Mommers
Paul M. Ossenkoppele
Marjolein I. A. Koetsier
Maartje A. Berends
Annick de Vries
Peter C. M. van de Kerkhof
Alfons A. den Broeder
Elke M. G. J. de Jong
Juul M. P. A. van den Reek
author_facet Selma Atalay
Sophie E. Berends
Hans M. M. Groenewoud
Ron A. A. Mathot
David M. Njoo
Johannes M. Mommers
Paul M. Ossenkoppele
Marjolein I. A. Koetsier
Maartje A. Berends
Annick de Vries
Peter C. M. van de Kerkhof
Alfons A. den Broeder
Elke M. G. J. de Jong
Juul M. P. A. van den Reek
author_sort Selma Atalay
collection DOAJ
description Background Biologics for psoriasis are registered in standard dosages. In patients with low disease activity, reduction of the dose by interval prolongation can prevent overtreatment, and lower risks and costs. However, fear for increased anti-drug antibody (ADA) formation due to interval prolongation of biologics is an important barrier.Objective To investigate the course of serum drug concentrations, ADA levels, and predictors for successful dose reduction of adalimumab, ustekinumab, and etanercept for psoriasis.Methods Patients were randomized to dose reduction (DR) or usual care (UC) and followed for one year. The course and extent of detectable ADA levels were expressed as proportions/relative risks for DR vs. UC. Association of baseline characteristics with successful tapering was investigated with log-binomial regression analysis.Results In total, 118 patients were included. In adalimumab-treated patients, no significant difference in the proportion of patients with relevant ADA levels in DR vs. UC was seen. For ustekinumab, relevant ADA development was absent in both groups. Baseline trough levels were not predictive for successful DR.Conclusions Immunogenicity may not increase by interval prolongation in psoriasis patients with low disease activity. This pilot provides important and reassuring insight into the pharmacological changes after dose tapering of adalimumab, etanercept, and ustekinumab.
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spelling doaj-art-ad632265c60a46b8abe8c28e75dffce52025-02-05T19:02:55ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532022-07-013352680268410.1080/09546634.2022.2043546Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trialSelma Atalay0Sophie E. Berends1Hans M. M. Groenewoud2Ron A. A. Mathot3David M. Njoo4Johannes M. Mommers5Paul M. Ossenkoppele6Marjolein I. A. Koetsier7Maartje A. Berends8Annick de Vries9Peter C. M. van de Kerkhof10Alfons A. den Broeder11Elke M. G. J. de Jong12Juul M. P. A. van den Reek13Department of Dermatology, Radboudumc, Nijmegen René Descartesdreef 1, Nijmegen, NetherlandsDepartment of Hospital Pharmacy, Academic Medical Center, Amsterdam, NetherlandsDepartment for Health Evidence, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, NetherlandsDepartment of Hospital Pharmacy, Academic Medical Center, Amsterdam, NetherlandsDepartment of Dermatology, Ziekenhuis Groep Twente, Hengelo, NetherlandsDepartment of Dermatology, Sint Anna Ziekenhuis, Geldrop, NetherlandsDepartment of Dermatology, Ziekenhuis Groep Twente, Almelo, NetherlandsDepartment of Dermatology, Gelre Ziekenhuizen, Apeldoorn, NetherlandsDepartment of Dermatology, Slingelandziekenhuis, Doetinchem, NetherlandsBiologics Lab, Bioanalysis, Sanquin Diagnostic Services, Amsterdam, NetherlandsDepartment of Dermatology, Radboudumc, Nijmegen René Descartesdreef 1, Nijmegen, NetherlandsDepartment of Rheumatology, Sint Maartenskliniek, Nijmegen, NetherlandsDepartment of Dermatology, Radboudumc, Nijmegen René Descartesdreef 1, Nijmegen, NetherlandsDepartment of Dermatology, Radboudumc, Nijmegen René Descartesdreef 1, Nijmegen, NetherlandsBackground Biologics for psoriasis are registered in standard dosages. In patients with low disease activity, reduction of the dose by interval prolongation can prevent overtreatment, and lower risks and costs. However, fear for increased anti-drug antibody (ADA) formation due to interval prolongation of biologics is an important barrier.Objective To investigate the course of serum drug concentrations, ADA levels, and predictors for successful dose reduction of adalimumab, ustekinumab, and etanercept for psoriasis.Methods Patients were randomized to dose reduction (DR) or usual care (UC) and followed for one year. The course and extent of detectable ADA levels were expressed as proportions/relative risks for DR vs. UC. Association of baseline characteristics with successful tapering was investigated with log-binomial regression analysis.Results In total, 118 patients were included. In adalimumab-treated patients, no significant difference in the proportion of patients with relevant ADA levels in DR vs. UC was seen. For ustekinumab, relevant ADA development was absent in both groups. Baseline trough levels were not predictive for successful DR.Conclusions Immunogenicity may not increase by interval prolongation in psoriasis patients with low disease activity. This pilot provides important and reassuring insight into the pharmacological changes after dose tapering of adalimumab, etanercept, and ustekinumab.https://www.tandfonline.com/doi/10.1080/09546634.2022.2043546Psoriasisadalimumabetanerceptustekinumabdose reductiondose tapering
spellingShingle Selma Atalay
Sophie E. Berends
Hans M. M. Groenewoud
Ron A. A. Mathot
David M. Njoo
Johannes M. Mommers
Paul M. Ossenkoppele
Marjolein I. A. Koetsier
Maartje A. Berends
Annick de Vries
Peter C. M. van de Kerkhof
Alfons A. den Broeder
Elke M. G. J. de Jong
Juul M. P. A. van den Reek
Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trial
Journal of Dermatological Treatment
Psoriasis
adalimumab
etanercept
ustekinumab
dose reduction
dose tapering
title Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trial
title_full Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trial
title_fullStr Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trial
title_full_unstemmed Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trial
title_short Serum drug levels and anti-drug antibodies in the context of dose tapering by interval prolongation of adalimumab, etanercept and ustekinumab in psoriasis patients: results of the CONDOR trial
title_sort serum drug levels and anti drug antibodies in the context of dose tapering by interval prolongation of adalimumab etanercept and ustekinumab in psoriasis patients results of the condor trial
topic Psoriasis
adalimumab
etanercept
ustekinumab
dose reduction
dose tapering
url https://www.tandfonline.com/doi/10.1080/09546634.2022.2043546
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