Drug Evaluation

Oregon Health & Sciences University, Division of Rheumatology, Portland, OR, USA

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Secia Beier

Oregon Health & Sciences University, Department of Pharmacy Services, Portland, OR, USA

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Julianna Desmarais

*Author for correspondence:

E-mail Address: desmaraj@ohsu.edu

Oregon Health & Sciences University, Division of Rheumatology, Portland, OR, USA

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Published Online:26 Mar 2024https://doi.org/10.2217/imt-2023-0225

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Abstract

Axial spondyloarthritis is a chronic, immune-mediated systemic inflammatory disease encompassing ankylosing spondylitis and nonradiographic axial spondyloarthritis. TNF inhibitors are the preferred second line therapy for patients with active axial spondyloarthritis. Certolizumab pegol is a TNF inhibitor approved for treatment of both. Three large phase III trials (RAPID-axSpA, C-axSpAnd and C-OPTIMISE) and one large phase IV trial (CIMAX) establish its clinical efficacy in treatment of active disease and maintenance of remission for both diseases. Real world evidence demonstrates clinical efficacy and benefits including reduced bone loss, reduced risk of uveitis, safety in pregnancy and lactation and index drug survival of 10 years. It is generally well tolerated, though can be associated with increased risk of serious infections.

Plain language summary

Axial spondyloarthritis is a chronic (long-lasting) autoimmune disease encompassing two other inflammatory conditions called ankylosing spondylitis and nonradiographic axial spondyloarthritis. A type of medicines, called tumor necrosis factor inhibitors, are the preferred second-line medicines for patients with active axial spondyloarthritis. Second line is treatment for a condition after the initial treatment has failed. Certolizumab pegol is one of these medicines approved for the treatment of both. Four large phase III or IV studies (RAPID-axSpA, C-axSpAnd, C-OPTIMISE and CIMAX) establish its effectiveness in the treatment of active disease and maintenance of remission (a period where disease symptoms have become less severe) for both diseases. Studies of its use in routine healthcare delivery show clinical efficacy (or effectiveness) and benefits including reduced bone loss, reduced risk of certain eye disease (uveitis), safety in pregnancy and lactation and 10-year effectiveness before the need for a medication change. It is generally well tolerated, though can be associated with increased risk of serious infections.

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The #TNFi #CZP is clinically effective in the treatment of both #axSpA subtypes, AS and nr-axSpA, as reviewed by #OHSU Rheumatology. #MedTwitter #AnkSpond

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Papers of special note have been highlighted as: • of interest; •• of considerable interest

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History

Received 5 September 2023

Accepted 4 March 2024

Published online 26 March 2024

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Keywords

Author contributions

E Anderson: Literature review, and writing of sections including abstract, introduction, clinical efficacy, conclusion, executive summary and editing. S Beier: Writing of sections including introduction to compound, pharmacology and regulatory affairs. J Desmarais: Literature review and writing of sections including real-world evidence, safety and tolerability and editing.

Acknowledgments

L Zeigen, OHSU Librarian.

Financial disclosure

The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

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Certolizumab pegol in the treatment of axial spondyloarthritis

Abstract

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References