Safety of treatment options for spondyloarthritis: a narrative review

ABSTRACT

Introduction: Spondyloarthritis (SpA) are chronic inflammatory diseases with overlapping pathogenic mechanisms and clinical features. Treatment armamentarium against SpA includes non-steroidal anti-inflammatory drugs, glucocorticoids, conventional disease-modifying antirheumatic drugs (DMARDs, including sulfasalazine, methotrexate, leflunomide, cyclosporine), targeted synthetic DMARDs (apremilast) and biological DMARDs (TNF inhibitors, anti-IL 12/23 and anti-IL-17 agents).

Areas covered: A narrative review of published literature on safety profile of available SpA treatment options was performed. Readers will be provided with a comprehensive overview on frequent and rare adverse events associated with each drug listed in current SpA treatment recommendations.

Expert opinion: The overall safety profile of such molecules is good and serious adverse events are rare but need to be promptly recognized and treated. However, the monitoring of adverse events is a major challenge for clinicians because it is not adequately addressed by current treatment recommendations. A tailored treatment is crucial and rheumatologists must accurately select patients in order to identify those more susceptible to develop adverse events.

KEYWORDS:

• Ankylosing spondylitis
• biologics
• DMARDs
• NSAIDs
• psoriatic arthritis
• safety
• spondyloarthritis

Article Highlights

• Safety of treatment options for SpA have been poorly addressed in international treatment recommendations;

• Similar to what observed in other conditions, the most common AEs during NSAIDs therapy for SpA are gastrointestinal and cardiovascular;

• Among conventional DMARDs, leflunomide seems associated with a higher withdrawal rate; however, the global risk of DMARDs withdrawal due to AEs is low;

• RCTs confirmed that apremilast is safe but extra care must be used in psychiatric patients because of the emerging risk of suicidal ideation and behavior;

• Massive data demonstrated that TNF inhibitors are generally safe, in particular if adequate screening for identifying subjects at risk for TB and HBV reactivation is performed;

• Although less data are available, UST and SEC are generally considered safe.

This box summarizes key points contained in the article.

Acknowledgments

The authors would like to express their special appreciation and thanks to Prof. Ignazio Olivieri who deceased in July 28th, 2017. He was an example of strength and tenacity with a contagious enthusiasm for a rigorous scientific research.

Declaration of interest

S D’Angelo has received consultancy fees from Abbvie, Bristol-Myers Squibb, Janssen MSD, Novartis, Pfizer and UCB. The authors have no other relevant affiliations or 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 apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Additional information

Funding

This paper has not been funded.