Analysis of the prevalence of ankylosing spondylitis and treatment patterns and drug utilization among affected patients: an Italian real-world study

ABSTRACT

Objectives

To evaluate the prevalence of ankylosing spondylitis (AS) and associated treatment patterns and drug utilization in real-world clinical practice in Italy.

Methods

This observational study used data from administrative databases of selected Italian entities and included patients with AS diagnosis identified by ICD-9-CM and/or exemption codes. Patients without biologic disease-modifying antirheumatic drug (bDMARD) prescriptions prior to inclusion were defined bio-naïve. A cross-sectional analysis identified treatment patterns from 2016 to 2018. A longitudinal analysis investigated bDMARD utilization (persistence, switch, discontinuing treatment) among bio-naïve patients, with 2014 and 2017 as inclusion periods. Follow-up extended from first bDMARD prescription (index date) to end of data availability.

Results

The prevalence of AS was 75.5 per 100,000 (88.3 per 100,000 in adults) in 2018. In total, 5,942 AS patients were identified in 2016, 6,554 in 2017, and 7,146 in 2018. bDMARDs were prescribed to 21.4% (2016), 22.0% (2017), and 16.9% (2018) of the patients. Among the 349 patients included in 2014, 9.5% switched therapies, 13.8% discontinued treatment. In 2017, 12.2% of the 262 patients included switched therapies, 27.1% discontinued treatment.

Conclusions

This study provided an up-to-date prevalence of AS diagnosis in Italy. Bio-naïve patients showed an increasing tendency toward switch of therapy and discontinuation.

KEYWORDS:

• Biologic agents
• bio-naïve
• real-life
• spondylarthritis therapeutic pathway

Acknowledgments

The present manuscript was edited for proper English language, grammar, punctuation, spelling, and overall style by Mary A. from American Journal Experts (AJE).

Declarations of interest

S Losi, E Filippi, S Antonelli, and M Giovannitti are employees of Eli Lilly Italy S.p.a. M Giovannitti is also an employee of Company Roma, Italy. The agreement signed by Clicon S.r.l. and Eli Lilly does not create any entityship, joint venture or any similar relationship between parties. Clicon S.r.l. is an independent company. Neither CliCon S.r.l. nor any of their representatives are employees of Eli Lilly for any purpose. 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.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Conceptualization: V Perrone and L Degli Esposti; data curation: V Perrone and L Degli Esposti; funding acquisition: L Degli Esposti; methodology: D Sangiorgi; supervision: L Degli Esposti; visualization: L Degli Esposti; interpretation of the data: V Perrone, S Losi, E Filippi, S Antonelli, M Giovannitti; writing—original draft: V Perrone and E Giacomini; writing—review and editing: V Perrone, S Losi, E Filippi, S Antonelli, M Giovannitti. All authors have read and approved the final version of the manuscript to be published.

Further details

An extract of this paper has been previously presented at the Virtual ISPOR European Congress 2020 (virtual) as a poster presentation with interim findings. The poster’s abstract was published in Value in Health, 2020; 23: S598-S599. 10.1016/j.jval.2020.08.1167.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

Eli Lilly purchased the study report that is the basis for this manuscript. This manuscript was developed with Eli Lilly and CliCon S.r.l.