Effectiveness of bDMARDs in ankylosing spondylitis patients by biologic use: experience from the CorEvitas PsA/SpA Registry

Abstract

Objective

To describe bDMARD initiators by biologic experience among ankylosing spondylitis (AS) patients and change in disease activity and patient-reported outcomes (PROs) in real-world US patients.

Methods

We included patients ≥18 years with AS based on physician diagnosis enrolled between 3/2013 and 11/2019 in the CorEvitas Psoriatic Arthritis (PSA)/Spondyloarthritis Registry (NCT02530268). Patients concurrently diagnosed with PSA were excluded. Baseline (bDMARD initiation) demographics, comorbidities, disease characteristics, treatment, and PROs were collected. Response rates and changes in disease activity and PROs between baseline and 6- and 12- month follow-up visits were calculated.

Results

Of the 489 AS patients in the PsA/SpA Registry, 254 AS (52.0%) patients initiated a bDMARD at enrollment or during follow-up (total initiations: AS = 313). Of the 313 AS initiations, 179 (57.2%) had a 6-month follow-up, 122 (39.0%) had a 12-month follow-up, and 94 (30.0%) had a 6- and 12-month follow-up visit. For those AS initiators with a 6-month follow-up, the mean age was 49.1 years, 44.4% were female, and 70.4%, 47.5%, 96.1%, and 46.9% had never used cDMARDs, TNFis, non-TNFis, and bDMARDs, respectively. Of these 179 AS initiators, 20.1% and 14.0% achieved ASAS20/40, respectively. Further, only 34% achieved low disease activity (ASDAS <2.1). When stratified by biologic-naivete and biologic-experience, the ASAS 20/40 achievement rates were 26.2% and 14.7%, and 21.4% and 7.4%, respectively, for this cohort.

Conclusion

Although AS patients initiate bDMARDs, many do not achieve optimal treatment responses. Future research is needed to investigate the aspects associated with inadequate improvement and treatment response to bDMARDs.

Keywords:

• Rheumatic diseases
• ankylosing spondylitis
• biologics
• patient-reported outcomes
• registries
• DMARD
• effectiveness
• real-world studies

Transparency

Declaration of funding

This was a collaborative effort between CorEvitas and Eli Lilly and Company, with financial support provided by Eli Lilly and Company. CorEvitas is supported through contracted subscriptions in the last two years by AbbVie, Amgen, Inc., Arena, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly and Company, Genentech, Gilead Sciences, Inc., GlaxoSmithKline, Janssen Pharmaceuticals, Inc., LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Inc., Regeneron Pharmaceuticals, Inc., Sanofi, Sun Pharmaceutical Industries Ltd., and UCB S.A.

Declaration of financial/other relationships

PJM: received research grants from AbbVie, Amgen, Inc., Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead Science, Inc., GlaxoSmithKline, Janssen Pharmaceuticals, Inc., Novartis, Pfizer, Inc., Sun Pharmaceutical Industries Ltd., and UCB S.A.; received consulting and/or speaker fees from AbbVie, Amgen, Inc., Bristol Myers Squibb, Eli Lilly and Company, Galapagos, Gilead Sciences, Inc., GlaxoSmithKline, Janssen Pharmaceuticals, Inc., Novartis, Pfizer, Inc., Sun Pharmaceutical Industries Ltd, and UCB S.A. TMH, WNM, JRL, and RJB are employees of Lilly/stock; TB is a current employee and BD is a former employee of CorEvitas, LLC; and LRH received grant funding from Pfizer and consulting fees from AbbVie, BMS, and Genentech; and is an employee/stock with CorEvitas, LLC. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Philip J. Mease, Taylor Blachley, William M. Malatestinic, Leslie R. Harrold, Jeffrey R. Lisse, and Theresa M. Hunter contributed to the concept and design of the study, the statistical analysis plan, report development and review, publication development and review, and are accountable for the final version of the manuscript. Rebecca J. Bolce and Blessing Dube contributed to the report development and review, publication development and review, and are accountable for the final version of the manuscript.

Acknowledgements

Support for third-party writing assistance for this manuscript, furnished by Michelle D. Karpman, PhD, of CorEvitas, LLC, was provided by Eli Lilly and Company, Indianapolis, IN. The authors would like to thank all the investigators, their clinical staff, and patients who participate in the CorEvitas PsA/SpA Registry.

Data availability statement

Data are available from CorEvitas, LLC through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.