Baseline predictors of response and discontinuation of tumor necrosis factor-alpha blocking therapy in ankylosing spondylitis: a prospective longitudinal observational cohort study

Abstract

IntroductionIdentifying ankylosing spondylitis (AS) patients who are likely to benefit from tumor necrosis factor-alpha (TNF-α) blocking therapy is important, especially in view of the costs and potential side effects of these agents. Recently, the AS Disease Activity Score (ASDAS) has been developed to assess both subjective and objective aspects of AS disease activity. However, data about the predictive value of the ASDAS with respect to clinical response to TNF-α blocking therapy are lacking. The aim of the present study was to identify baseline predictors of response and discontinuation of TNF-α blocking therapy in AS patients in daily clinical practice.MethodsAS outpatients who started TNF-α blocking therapy were included in the Groningen Leeuwarden Ankylosing Spondylitis (GLAS) study, an ongoing prospective longitudinal observational cohort study with follow-up visits according to a fixed protocol. For the present analysis, patients were excluded if they had previously received anti-TNF-α treatment. Predictor analyses of response and treatment discontinuation were performed using logistic and Cox regression models, respectively.ResultsBetween November 2004 and April 2010, 220 patients started treatment with infliximab (n = 32), etanercept (n = 137), or adalimumab (n = 51). At three and six months, 68% and 63% of patients were Assessments in Ankylosing Spondylitis (ASAS)20 responders, 49% and 46% ASAS40 responders, and 49% and 50% Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 responders, respectively. Baseline predictors of response were younger age, male gender, higher ASDAS score, higher erythrocyte sedimentation rate (ESR) level, higher C-reactive protein (CRP) level, presence of peripheral arthritis, higher patient's global assessment of disease activity, and lower modified Schober test. In August 2010, 64% of patients were still using their TNF-α blocking agent with a median follow-up of 33.1 months (range 2.4 to 68.2). Baseline predictors of discontinuation of TNF-α blocking therapy were female gender, absence of peripheral arthritis, higher BASDAI, lower ESR level, and lower CRP level.ConclusionsBesides younger age and male gender, objective variables such as higher inflammatory markers or ASDAS score were identified as independent baseline predictors of response and/or continuation of TNF-α blocking therapy. In contrast, higher baseline BASDAI score was independently associated with treatment discontinuation. Based on these results, it seems clinically relevant to include more objective variables in the evaluation of anti-TNF-α treatment.

Treatment patterns of biologics in US patients with ankylosing spondylitis: descriptive analyses from a claims database

“…Although the current study did not evaluate the reasons patients switched or discontinued TNFi therapy, previous studies have shown that approximately 30-36% of patients with AS, discontinued or switched biologic therapy because of adverse events [35,36] or lack of treatment effect [37]. Although no specific TNFi has been shown to be more effective than another in patients with AS [12,38], studies of TNFi treatment patterns provide better understanding of real-world use.…”

Effect of Adalimumab on an Enterocutaneous Fistula in Patients with Crohn's Disease: A Case Series

“…Regarding other concomitant agents, steroid use at enterocutaneous fistula onset has been reported to be a negative predictor of anti-TNF failure (9). Moreover, a higher level of CRP is reported to be a significant negative predictor in patients treated with biological agents, although these reports describe patients with rheumatoid arthritis and ankylosing spondylitis (19,20). Interestingly, in this case series, the two cases that failed to achieve fistula closure did not receive azathioprine, and the case that showed sustained complete remission of the fistula received concomitant azathioprine; additionally, the initial CRP level of case 3 was the lowest among these three patients.…”

Não adesão à terapia biológica em pacientes com doenças reumáticas no Sistema Único de Saúde em Minas Gerais, Brasil

“…Curkendall et al 6 também encontraram associação do sexo feminino à alta taxa de não adesão aos biológicos adalimumabe e etanercepte. As razões para a menor taxa de não adesão entre os homens ainda é desconhecida 27 . Entretanto, em uma revisão sistemática que identificou fatores associados à adesão no tratamento da artrite reumatoide 26 , o sexo apresentou associação conflitante.…”