SEARCHSYSTEMATIC_REVIEWrheumatology, immunology

systematic_review·rheumatology, immunology, clinical trial, systematic review·PMC10729619

The pharmacological treatment of granulomatosis with polyangiitis: a review of clinical trials registered in clinicaltrials.gov and the International Clinical Trials Registry Platform

Therapeutic Advances in Rare Disease · 7 authors, 9 centres

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AGENT 01 · STRUCTURED SUMMARY

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TL;DR

This systematic review identified 108 clinical trials for granulomatosis with polyangiitis (GPA) from two global registries, finding most studies enrolled all severity types and focused on remission induction. The most commonly investigated drug classes were non-corticosteroid immunosuppressants, monoclonal antibodies, and corticosteroids.

Full summary

372 CHARS

This systematic review analyzed clinical trials for GPA registered in ClinicalTrials.gov and the ICTRP up to September 2022. The authors identified 108 GPA-specific studies, of which 67 (62%) focused on pharmacotherapy. The most frequently studied drug classes were non-corticosteroid immunosuppressants (68.7%), monoclonal antibodies (47.8%), and corticosteroids (46.3%).

STUDY TYPE

systematic_review

SPECIALTY

rheumatology

SUMMARISED BY

AI pipeline

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100% · A

ORIGINAL PAPER

PMC10729619

The pharmacological treatment of granulomatosis with polyangiitis: a review of clinical trials registered in clinicaltrials.gov and the International Clinical Trials Registry Platform

Therapeutic Advances in Rare Disease

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ABSTRACT

To date, there is no published overview of the drug pipeline in granulomatosis with polyangiitis (GPA), a rare disease. The aim of this study was to identify clinical trials from two study repositories. A review of clinical trials was conducted using publicly available data. Clinicaltrials.gov and International Clinical Trials Registry Platform were searched from inception until 25 September 2022. Only GPA-specific studies were included; these were described in detail. A total of 137 studies were identified in the trial repositories, of which 108 (79%) studies were found to concern GPA. Of these 108 studies, 67 enrolled GPA patients to investigate pharmacotherapy in this disease (62%). Most studies included all severity types ( n = 51; 76%); the scope of almost half of the studies was remission induction ( n = 33; 49%). The drug class which was by the most widely investigated in trials was the non-corticosteroid immunosuppressant drug class (46; 68.7%), monoclonal antibodies (32; 47.8%), and corticosteroids (31; 46.3%). There is a need for more GPA trials to generate evidence on effectiveness in terms of severity-specificity and maintenance of remission.

CITATION EXPORT

Janet Sultana, Nikita Camilleri, Salvatore Crisafulli et al.. The pharmacological treatment of granulomatosis with polyangiitis: a review of clinical trials registered in clinicaltrials.gov and the International Clinical Trials Registry Platform. Therapeutic Advances in Rare Disease. (2023). https://doi.org/10.1177/26330040231213888

AUTHORS

7 · 9 CENTRES

Janet Sultana, Nikita Camilleri, Salvatore Crisafulli, John Joseph Borg, Silvan Spagnol, Silvia Tillati, Joseph Borg

Exeter College of Medicine and Health, St. Luke’s Campus, Exeter, EX4 4QJ, UK
Quality Improvement, Pharmacy Department, Mater Dei Hospital, Msida, Malta
Applied Biomedical Science, Faculty of Health Sciences, Mater Dei Medical School, Msida, Malta
Applied Biomedical Science, Faculty of Health Sciences, Mater Dei Medical School, Msida, Malta
Department of Medicine, University of Verona, Verona, Italy
Post-licensing Department, Malta Medicines Authority, Msida, Malta
Quality Improvement, Pharmacy Department, Mater Dei Hospital, Msida, Malta
Unit of Medical Statistics, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
Applied Biomedical Science, Faculty of Health Sciences, Mater Dei Medical School, Msida, Malta