Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice

Background: Limited information exists on the risk of adverse events (AEs) attributed to methotrexate (MTX) and biologics for the treatment of psoriasis/psoriatic arthritis (PsA/PsO) in heterogeneous clinical practice and beyond the duration of clinical trials. Methods: An observational study of 629...

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Main Authors: Faizan Mazhar, Åsa Krantz, Lovisa Schalin, Josefin Lysell, Juan Jesus Carrero
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Series:Journal of Dermatological Treatment
Subjects:
Online Access:http://dx.doi.org/10.1080/09546634.2023.2215354
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author Faizan Mazhar
Åsa Krantz
Lovisa Schalin
Josefin Lysell
Juan Jesus Carrero
author_facet Faizan Mazhar
Åsa Krantz
Lovisa Schalin
Josefin Lysell
Juan Jesus Carrero
author_sort Faizan Mazhar
collection DOAJ
description Background: Limited information exists on the risk of adverse events (AEs) attributed to methotrexate (MTX) and biologics for the treatment of psoriasis/psoriatic arthritis (PsA/PsO) in heterogeneous clinical practice and beyond the duration of clinical trials. Methods: An observational study of 6294 adults with incident PsA/PsO who initiated MTX or biologics in Stockholm from 2006-2021 was conducted. The risk of kidney, liver, hematological, serious infectious, and major gastrointestinal AEs was quantified and compared between therapies using incidence rates, absolute risks, and adjusted hazard ratios (HRs) from propensity-score weighted Cox regression. Results: Median follow-up was 4.3 (2–7) years. Users of MTX had a higher risk of anemia (HR 1.79 [95% CI, 1.48–2.16]), particularly mild-moderate anemias (1.93;1.49–2.50), and mild (1.46;1.03–2.06) and moderate-severe liver AEs (2.22;1.19–4.15) compared to biologics. Chronic kidney disease incidence did not differ between therapies (affecting 1.5% of the population in 5 years; HR:1.03;0.48–2.22). Acute kidney injury, serious infections, and major gastrointestinal AEs showed low absolute risks and no clinically meaningful differences between both therapies. Conclusion: The use of MTX for psoriasis patients in routine care was associated with a higher risk of anemia and liver AEs than biologics, but similar risks of kidney, serious infections, and major gastrointestinal AEs.
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spelling doaj.art-e37cb78a708c40e5ad52e0c389a73dc72023-09-15T14:28:53ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532023-12-0134110.1080/09546634.2023.22153542215354Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practiceFaizan Mazhar0Åsa Krantz1Lovisa Schalin2Josefin Lysell3Juan Jesus Carrero4Department of Medical Epidemiology and Biostatistics, Karolinska InstitutetDermatology and Venereology Section, Department of Medicine Solna, Karolinska InstitutetEpidemiology, AmgenDermatology and Venereology Section, Department of Medicine Solna, Karolinska InstitutetDepartment of Medical Epidemiology and Biostatistics, Karolinska InstitutetBackground: Limited information exists on the risk of adverse events (AEs) attributed to methotrexate (MTX) and biologics for the treatment of psoriasis/psoriatic arthritis (PsA/PsO) in heterogeneous clinical practice and beyond the duration of clinical trials. Methods: An observational study of 6294 adults with incident PsA/PsO who initiated MTX or biologics in Stockholm from 2006-2021 was conducted. The risk of kidney, liver, hematological, serious infectious, and major gastrointestinal AEs was quantified and compared between therapies using incidence rates, absolute risks, and adjusted hazard ratios (HRs) from propensity-score weighted Cox regression. Results: Median follow-up was 4.3 (2–7) years. Users of MTX had a higher risk of anemia (HR 1.79 [95% CI, 1.48–2.16]), particularly mild-moderate anemias (1.93;1.49–2.50), and mild (1.46;1.03–2.06) and moderate-severe liver AEs (2.22;1.19–4.15) compared to biologics. Chronic kidney disease incidence did not differ between therapies (affecting 1.5% of the population in 5 years; HR:1.03;0.48–2.22). Acute kidney injury, serious infections, and major gastrointestinal AEs showed low absolute risks and no clinically meaningful differences between both therapies. Conclusion: The use of MTX for psoriasis patients in routine care was associated with a higher risk of anemia and liver AEs than biologics, but similar risks of kidney, serious infections, and major gastrointestinal AEs.http://dx.doi.org/10.1080/09546634.2023.2215354psoriasismethotrexatebiologicssafetyadverse events
spellingShingle Faizan Mazhar
Åsa Krantz
Lovisa Schalin
Josefin Lysell
Juan Jesus Carrero
Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice
Journal of Dermatological Treatment
psoriasis
methotrexate
biologics
safety
adverse events
title Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice
title_full Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice
title_fullStr Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice
title_full_unstemmed Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice
title_short Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice
title_sort occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice
topic psoriasis
methotrexate
biologics
safety
adverse events
url http://dx.doi.org/10.1080/09546634.2023.2215354
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