Sex-specific disparities in disease activity scores among patients with axial spondyloarthritis and their implications for evaluating the response to tumor necrosis factor alpha inhibitor therapy.

BACKGROUND: We aimed to investigate whether there are sex differences in disease activity measures among patients with axial spondyloarthritis (axSpA) and to determine any potential impact on the assessment of treatment responses to tumor necrosis factor alpha inhibitors (TNFi). METHODS: Using the Korean College of Rheumatology Biologics and Targeted Therapy (KOBIO) registry data, we compared sex differences in changes in the Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) levels at baseline and one year after TNFi initiation in patients with axSpA. RESULTS: This study included 1,753 patients with axSpA who started or changed TNFi, of whom 1,343 (76.6%) were male. At baseline, the mean BASDAI and ASDAS scores of all patients were 5.98 and 3.6, respectively. The BASDAI changes between baseline and the one-year follow-up were independently associated with sex (𝛽 = 0.343, p = 0.011), whereas ASDAS was not (𝛽 = 0.079, p = 0.235). When judging the effect of TNFi at one-year of treatment, male patients were more likely to be assessed as effective by the BASDAI-based criterion (ΔBASDAI ≥ 50% or ≥ 2; OR 1.700, 95% CI 1.200-2.406), while the ASDAS-based criterion (ΔASDAS ≥ 1.1) showed no significant difference between sexes (OR 0.993, 95% CI 0.678-1.455), after adjusting for other baseline characteristics. CONCLUSIONS: The changes in disease activity before and after TNFi use were significantly different between sexes when measured by BASDAI, but not ASDAS. TNFi treatment effects may be interpreted differently between sexes depending on the disease activity measure used.

Corrigendum: Korean treatment recommendations for patients with axial spondyloarthritis.

[This corrects the article on p. 151 in vol. 30, PMID: 37476674.].

Higher body mass index and anti-drug antibodies predict the discontinuation of anti-TNF agents in Korean patients with axial spondyloarthritis / O maior índice de massa corporal e a presença de anticorpos antifármacos predizem a interrupção no uso de agentes anti-TNF em pacientes sul-coreanos com espondiloartrite axial

ABSTRACT Objective: The development of anti-drug antibodies against tumor necrosis factor inhibitors is a likely explanation for the failure of TNF-inhibitors in patients with spondyloarthritis. Our study determined the existence and clinical implications of ADAbs in axial spondyloarthritis patients. Methods: According to the Assessment of SpondyloArthritis International Society classification criteria for axial spondyloarthritis, patients treated with adalimumab or infliximab were recruited consecutively. Serum samples were collected at enrollment to measure anti-drug antibodies and drug levels. Results: Of 100 patients, the mean duration of current TNF inhibitor use was 22.3 ± 17.9 months. Anti-drug antibodies were detected in 5 of 72 adalimumab users compared to 5 of 28 infliximab users (6.9% vs. 17.9%). Anti-drug antibodies-positive patients had a significantly higher body mass index than anti-drug antibodies-negative patients among both adalimumab (28.4 ± 5.9 kg/m2 vs. 24.3 ± 2.9 kg/m2, respectively, p = 0.01) and infliximab users (25.9 ± 2.8 kg/m2 vs. 22.6 ± 2.8 kg/m2, respectively, p = 0.02). During the median 15-month follow-up period, drug discontinuation occurred more frequently in the anti-drug antibodies-positive group than the anti-drug antibodies-negative group (30.0% vs. 6.5%, respectively, p = 0.04). In logistic regression, anti-drug antibodies positivity (OR = 5.85, 95% CI 1.19-28.61, p = 0.029) and body mass index (OR = 4.35, 95% CI 1.01-18.69, p = 0.048) were associated with a greater risk of stopping TNF inhibitor treatment. Conclusions: Our result suggests that the presence of anti-drug antibodies against adalimumab and infliximab as well as a higher body mass index can predict subsequent drug discontinuation in axial spondyloarthritis patients.

RESUMO Objetivo: O desenvolvimento de anticorpos antifármacos (ADAb) contra o fator de necrose tumoral (TNF) é uma explicação provável para a falha dos anti-TNF em pacientes com espondiloartrites (EspA). O presente estudo determinou a presença e as implicações clínicas dos ADAb em pacientes com EspA axiais. Métodos: De acordo com os critérios de classificação para EspA axial da Assessment of SpondyloArthritis International Society, recrutaram-se consecutivamente pacientes tratados com adalimumabe ou infliximabe. Coletaram-se amostras de soro no momento da entrada no estudo para medir os níveis de ADAb e de fármaco. Resultados: Dos 100 pacientes, a duração média de uso dos anti-TNF atuais foi de 22,3 ± 17,9 meses. Os ADAb foram detectados em cinco de 72 pacientes em uso de adalimumabe, em comparação com cinco de 28 usuários de infliximabe (6,9% vs. 17,9%). Os pacientes ADAb-positivos tinham um índice de massa corporal maior do que aqueles ADAb-negativos, tanto entre indivíduos em uso de adalimumabe (28,4 ± 5,9 kg/m2 vs. 24,3 ± 2,9 kg/m2, respectivamente, p = 0,01) quanto de infliximabe (25,9 ± 2,8 kg/m2 vs. 22,6 ± 2,8 kg/m2 respectivamente, p = 0,02). Durante o período médio de seguimento de 15 meses, a suspensão do fármaco ocorreu com maior frequência no grupo ADAb-positivo do que no grupo ADAb-negativo (30,0% vs. 6,5%, respectivamente, p = 0,04). Na regressão logística, a positividade no ADAb (OR = 5,85, IC 95% 1,19 a 28,61, p = 0,029) e o IMC (OR = 4,35, IC 95% 1,01 a 18,69, p = 0,048) esteve associada a um maior risco de interromper o tratamento com anti-TNF. Conclusões: Os resultados do presente estudo sugerem que a presença de ADAb contra o adalimumabe e o infliximabe, bem como um IMC mais alto, pode predizer a subsequente interrupção do fármaco em pacientes com EspA axial.