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Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region

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Abstract

Background

The impact of psoriasis, response to treatment, and patients’ perceptions of treatment satisfaction vary by body area.

Objectives

We aimed to evaluate the level of response in lower limbs versus other body regions in patient with moderate to severe psoriasis treated with secukinumab and ustekinumab.

Methods

Data were pooled from CLEAR and CLARITY trials, which included patients with moderate to severe plaque psoriasis (Psoriasis Area and Severity Index [PASI] score of ≥ 12) aged ≥ 18 years and a diagnosis of ≥ 6 months before randomisation. Patients received either secukinumab 300 mg or ustekinumab 45/90 mg. The PASI 100 responders and mean PASI scores at weeks 4, 12, 16, 28, 40 and 52 in the head and neck, trunk, upper limbs and lower limbs were measured.

Results

At baseline, analysis of PASI scores for each body region revealed that the lower limbs were the most severely affected body region in both treatment arms (mean PASI scores: secukinumab 24.0; ustekinumab 24.4). For both drugs, the highest clearance rates at week 52 were achieved in the trunk (secukinumab 85.2% vs ustekinumab 68.7%) and head and neck (80.7% vs 68.9%), followed by the upper limbs (72.6% vs 61.9%) and lower limbs (68.1% vs 57.2%). At week 52, the mean PASI score was higher in the lower limbs in both treatment arms versus other body regions.

Conclusions

Lower limbs were the most severely affected and most difficult-to-treat regions in patients with psoriasis. Consistent with the individual results of both studies, secukinumab demonstrated numerically faster and higher skin clearance than ustekinumab in all body regions.

Clinical Trial Registration

CLEAR: NCT02074982; CLARITY: NCT02826603.

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Acknowledgements

The medical writing support was provided by Avinash Thakur and Shilpa Kakkar (Novartis Healthcare Pvt. Ltd, Hyderabad, India), which was funded by Novartis Pharma AG, in accordance with Good Publication Practice guidelines.

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Authors and Affiliations

  1. Dermatology Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal

    Miguel Alpalhão & Paulo Filipe

  2. Dermatology University Clinic, Faculty of Medicine, University of Lisbon, Lisbon, Portugal

    Miguel Alpalhão & Paulo Filipe

  3. Dermatology Research Unit, iMM Lobo Antunes, University of Lisbon, Lisbon, Portugal

    Miguel Alpalhão & Paulo Filipe

  4. Medical Department-IHD, Novartis Pharma, Lisbon, Portugal

    Joana Duarte & Rita Diogo

  5. Novartis Pharma AG, Basel, Switzerland

    Marc Vandemeulebroecke, Christine-Elke Ortmann & Torben Kasparek

Authors
  1. Miguel Alpalhão
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  2. Joana Duarte
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  3. Rita Diogo
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  4. Marc Vandemeulebroecke
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  5. Christine-Elke Ortmann
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  7. Paulo Filipe
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Corresponding author

Correspondence to Miguel Alpalhão.

Ethics declarations

Funding

This study was funded by Novartis Pharma AG. The funder had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Conflict of interest

Miguel Alpalhão collaborated with the pharmaceutical industry as a speaker for Almirall, Janssen, Leo and Sanofi, a scientific consultant for AbbVie and Novartis, and has participated as an investigator in multicentric clinical trials with AbbVie, Eli-Lilly, Leo and Novartis. Rita Diogo, Marc Vandemeulebroecke, Christine-Elke Ortmann and Torben Kasparek are employees of Novartis. Joana Duarte was an employee of Novartis during study conduct and until manuscript development. Paulo Filipe has collaborated with the pharmaceutical industry as a speaker, scientific consultant and investigator in multicentric clinical trials with AbbVie, Almirall, Boehringer-Ingelheim, Eli-Lilly, Janssen, Leo, Merck-Sharp-Dohme (MSD), Novartis, Pfizer and Sanofi.

Ethics approval

This study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. The protocols were approved by the relevant institutional review board or ethics committee at each study site.

Consent to participate

Written informed consent was obtained from all individual participants included in both studies.

Consent to publish

Not applicable.

Code availability

Not applicable.

Availability of data and material

The datasets generated and/or analysed during the current study are not publicly available. Novartis is committed to sharing with qualified external researchers access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved based on scientific merit. All data provided are anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The data may be requested from the corresponding author.

Authors’ contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by TK, JD, RD, C-EO and MV. All authors contributed to drafting and critical appraisal of the manuscript and approved the final version for submission.

Meeting presentations

This study was presented in part at 29th European Academy of Dermatology and Venereology, Virtual Congress, 29–31 October, 2020.

Supplementary Information

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Alpalhão, M., Duarte, J., Diogo, R. et al. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs 36, 781–789 (2022). https://doi.org/10.1007/s40259-022-00558-2

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