AB0869 REAL-WORLD BURDEN OF UNCONTROLLED DISEASE DESPITE TREATMENT WITH TUMOR NECROSIS FACTOR INHIBITORS AMONG AXIAL SPONDYLOARTHRITIS PATIENTS IN THE COREVITAS PSORIATIC ARTHRITIS/SPONDYLOARTHRITIS REGISTRY
Authors: A. Ogdie, X. Ye, C. D. Saffore, B. Parikh, T. Iyile, T. Blachley, M. Eliot, N. Middaugh, P. J. Mease
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by the involvement of the spine and sacroiliac joints that may result in permanent damage and reduced functional abilities [1]. Biologic therapies, such as tumor necrosis factor inhibitors (TNFis), have revolutionized the management of axSpA, yet despite the success of TNFis, many patients with axSpA continue to experience suboptimal disease control [2]. <h3>Objectives:</h3> This study aims to quantify the disease burden in patients with axSpA who initiated and maintained a TNFi, but who did not achieve optimal Bath Ankylosing Spondylitis Disease Activity Index-50 (BASDAI50) disease control after two consecutive follow-up visits through 12 months, compared to patients who did achieve disease control. <h3>Methods:</h3> This study included patients with axSpA enrolled in the CorEvitas Psoriatic Arthritis/axSpA Registry from Sept 2013 to Feb 2023 who initiated and persisted on the same TNFi of any line of therapy with valid baseline, 6-month, and 12-month follow-up visits. Patients were categorized into 4 subgroups according to their BASDAI50 (indicating a 50% improvement from the original score) status: a) sustained (achieved BASDAI50 at 6(±3)- and 12(±3)-month follow-up visits); b) improved (did not achieve BASDAI50 at 6-months but did achieve at 12-months); c) worsened (achieved BASDAI50 at the 6-month follow-up but lost BASDAI50 at 12-months); and d) never achieved (did not achieve BASDAI50 at the 6- or 12-month visit). Patient characteristics at baseline were summarized using mean and standard deviation (SD) or frequencies and percentages. Frequency and proportions of patients achieving functional, clinical, and quality-of-life outcomes at 6-and-12-month follow-up were summarized for sustained and never achieved subgroups. The association between BASDAI50 subgroup (sustained vs. never achieved) and achievement of clinical outcomes, as well as those who met or exceeded a minimum clinically important difference (MCID) in patient-reported outcomes (PROs) at 6- and 12-months follow-up, were estimated using Poisson regression models, and covariate-adjusted relative risk ratios (95% CI) are reported. <h3>Results:</h3> A total of 152 patients with axSpA who initiated and persisted on TNFi were included: 19 (13%) sustained BASDAI50, 11 (7%) improved, 12 (8%) worsened, and 110 (72%) never achieved BASDAI50. Out of the total TNFi initiators, 80% (n=121) failed to achieve disease control within 6 months and among these patients, 91% (n=110/121) never achieved BASDAI50 at 12 months despite persistent TNFi therapy. At baseline, lesser disease and PRO symptomology was reported among the sustained BASDAI50 subgroup compared to the never achieved (Table 1). Patients who never achieved BASDAI50 experienced higher disease activity and worse PROs at 6 and 12 months versus those who sustained BASDAI50 (eg, Ankylosing Spondyloarthritis Disease Activity Score Low Disease Activity 6 months= 14% v 88% and 12 months= 9% v 100%) (Figure 1). Results of modified Poisson regression models show those sustaining BASDAI50 have approximately ≥2 times the likelihood of achieving disease activity measures and MCID in PROs in covariate-adjusted analyses compared to those never achieving BASDAI50. <h3>Conclusion:</h3> Despite initiating treatment with TNFis and maintaining therapy, 8 in 10 patients failed to achieve disease control as measured by BASDAI50 at 6 months; of these, 9 in 10 patients failed to achieve BASDAI50 at 12 months. Failure to achieve BASDAI50 at 6 and 12-months was associated with significantly worse disease activity and PROs than in patients who achieved BASDAI50 at either time points. These results support the need for physicians to consider changes in therapy prior to 12 months if targets have not been met on therapy by 6 months. <h3>REFERENCES:</h3> [1] Navarro-Compán, V<i>, et al. Ann Rheum Dis</i>. 2021. <b>80</b>(12): p. 1511-1521. [2] Ritchlin, C<i>, et al. BMJ</i>. 2021. <b>372</b>. <h3>Acknowledgements:</h3> The design, study conduct, and financial support for the study was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. This study is sponsored by CorEvitas, LLC. CorEvitas has been 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. Data are available from CorEvitas, LLC through a commercial subscription agreement and are not publicly available. No additional data are available from the authors. No honoraria or payments were made for authorship. Medical writing support was provided by Nakeirah Christie, PhD, of Fishawack Facilitate Ltd, part of Avalere Health, funded by AbbVie. <h3>Disclosure of Interests:</h3> Alexis Ogdie AbbVie, Amgen, BMS, Celgene, Corrona, Eli Lilly, Janssen, Novartis, and Pfizer, Xiaolan Ye AbbVie, AbbVie, Christopher D. Saffore AbbVie, AbbVie, Bhumik Parikh AbbVie, AbbVie, Thomas Iyile AbbVie, AbbVie, Taylor Blachley CorEvitas LLC (formerly Corrona, LLC). CorEvitas is supported through contracted subscriptions with multiple pharmaceutical companies. This study was a collaborative effort between CorEvitas and AbbVie with financial support provided by AbbVie., Melissa Eliot CorEvitas LLC (formerly Corrona, LLC). CorEvitas is supported through contracted subscriptions with multiple pharmaceutical companies. This study was a collaborative effort between CorEvitas and AbbVie with financial support provided by AbbVie., Nicole Middaugh CorEvitas LLC (formerly Corrona, LLC). CorEvitas is supported through contracted subscriptions with multiple pharmaceutical companies. This study was a collaborative effort between CorEvitas and AbbVie with financial support provided by AbbVie., Philip J. Mease AbbVie, Acelyrin, Aclaris, Alumis, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Inmagene, Janssen, Moonlake Pharma, Novartis, Pfizer, SUN Pharma, UCB, Takeda, Ventyx, and Xinthera., AbbVie, Acelyrin, Aclaris, Alumis, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Inmagene, Janssen, Moonlake Pharma, Novartis, Pfizer, SUN Pharma, UCB, Takeda, Ventyx, and Xinthera., AbbVie, Acelyrin, Aclaris, Alumis, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Inmagene, Janssen, Moonlake Pharma, Novartis, Pfizer, SUN Pharma, UCB, Takeda, Ventyx, and Xinthera.