TY - JOUR
T1 - Sex differences in the effectiveness of first-line tumour necrosis factor inhibitors in axial spondyloarthritis
T2 - Results from the EuroSpA Research Collaboration Network
AU - Hellamand, Pasoon
AU - van de Sande, Marleen
AU - Ørnbjerg, Lykke Midtbøll
AU - Klausch, Thomas
AU - Nurmohamed, Michael T.
AU - van Vollenhoven, Ronald F.
AU - Nordström, Dan
AU - Hokkanen, Anna Mari
AU - Santos, Maria Jose
AU - Vieira-Sousa, Elsa
AU - Loft, Anne G.
AU - Glintborg, Bente
AU - Hetland, Merete Lund
AU - Lindström, Ulf
AU - Wallman, Johan K.
AU - Michelsen, Brigitte
AU - Klami Kristianslund, Eirik
AU - Ciurea, Adrian
AU - Nissen, Michael S.
AU - Codreanu, Catalin
AU - Mogosan, Corina
AU - Macfarlane, Gary J.
AU - Rotariu, Ovidiu
AU - Rotar, Ziga
AU - Tomšič, Matija
AU - Castrejon, Isabel
AU - Otero-Varela, Lucia
AU - Gudbjornsson, Bjorn
AU - Geirsson, Arni Jon
AU - Vencovský, Ji Í
AU - Pavelka, Karel
AU - Gulle, Semih
AU - Zengin, Berrin
AU - Iannone, Florenzo
AU - Foti, Rosario
AU - Ostergaard, Mikkel
AU - van der Horst-Bruinsma, Irene
N1 - Funding Information: The EuroSpA Research Collaboration Network was financially supported by Novartis Pharma AG. Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/12/12
Y1 - 2023/12/12
N2 - Objective Evidence indicates reduced treatment effectiveness of TNFi in women with axial spondyloarthritis (axSpA) compared with men. We aimed to investigate sex differences in treatment response and retention rates over 24 months of follow-up in axSpA patients initiating their first TNFi. Methods Data from axSpA patients initiating a TNFi in 1 of 15 registries within EuroSpA collaboration were pooled. We investigated the association of sex with treatment response using logistic regression. The primary outcome was clinically important improvement (CII) at 6 months according to Ankylosing Spondylitis Disease Activity Score with C-reactive protein (CRP) (≥1.1 decrease). We adjusted for age, country and TNFi start year. A secondary outcome was retention rates over 24 months of follow-up assessed by Kaplan-Meier estimator. Results In total, 6451 axSpA patients with data on CII were assessed for treatment response; 2538 (39%) were women and 3913 (61%) were men. Women presented at baseline with lower CRP levels but had higher scores on patient-reported outcome measures. At 6 months, 53% of the women and 66% of the men had CII. Women had a lower relative risk of CII compared with men (0.81; 95% CI 0.77 to 0.84). This sex difference was similar in adjusted analysis (0.85; 95% CI 0.82 to 0.88). Retention rates were evaluated in 27 702 patients. The TNFi 6/12/24 months retention rates were significantly lower among women (79%/66%/53%) than men (88%/79%/69%). Conclusion Treatment response and retention rates are lower among women with axSpA initiating their first TNFi. Sex differences in treatment effectiveness were present regardless of the outcome measure used for treatment response, and differences in retention rates transpired early and increased as time progressed.
AB - Objective Evidence indicates reduced treatment effectiveness of TNFi in women with axial spondyloarthritis (axSpA) compared with men. We aimed to investigate sex differences in treatment response and retention rates over 24 months of follow-up in axSpA patients initiating their first TNFi. Methods Data from axSpA patients initiating a TNFi in 1 of 15 registries within EuroSpA collaboration were pooled. We investigated the association of sex with treatment response using logistic regression. The primary outcome was clinically important improvement (CII) at 6 months according to Ankylosing Spondylitis Disease Activity Score with C-reactive protein (CRP) (≥1.1 decrease). We adjusted for age, country and TNFi start year. A secondary outcome was retention rates over 24 months of follow-up assessed by Kaplan-Meier estimator. Results In total, 6451 axSpA patients with data on CII were assessed for treatment response; 2538 (39%) were women and 3913 (61%) were men. Women presented at baseline with lower CRP levels but had higher scores on patient-reported outcome measures. At 6 months, 53% of the women and 66% of the men had CII. Women had a lower relative risk of CII compared with men (0.81; 95% CI 0.77 to 0.84). This sex difference was similar in adjusted analysis (0.85; 95% CI 0.82 to 0.88). Retention rates were evaluated in 27 702 patients. The TNFi 6/12/24 months retention rates were significantly lower among women (79%/66%/53%) than men (88%/79%/69%). Conclusion Treatment response and retention rates are lower among women with axSpA initiating their first TNFi. Sex differences in treatment effectiveness were present regardless of the outcome measure used for treatment response, and differences in retention rates transpired early and increased as time progressed.
KW - ankylosing spondylitis
KW - biological therapy
KW - epidemiology
KW - spondylitis, ankylosing
KW - tumor necrosis factor inhibitors
UR - http://www.scopus.com/inward/record.url?scp=85180089147&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/rmdopen-2023-003325
DO - https://doi.org/10.1136/rmdopen-2023-003325
M3 - Article
SN - 2056-5933
VL - 9
JO - RMD open
JF - RMD open
IS - 4
M1 - e003325
ER -