Age at treatment predicts reason for discontinuation of TNF antagonists: data from the BIOBADASER 2.0 registry

Busquets, Noemí; Tomero, Eva; Descalzo, Miguel Ángel; Ponce, Andrés; Ortiz-Santamaría, Vera; Surís, Xavier; Carmona, Loreto; Gόmez-Reino, J.J.

doi:10.1093/rheumatology/ker281

Cited by 45 publications

(28 citation statements)

References 17 publications

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“…AS patients treated with a first TNF inhibitor had a good overall drug survival rate, with 79% of patients remaining on treatment after 2 yr. By contrast, RA patients treated with a first TNF inhibitor had a continuation rate of 44% after 1 yr. These findings are consistent with those of previous studies, including the Danish DANBIO (13, 14), Spanish BIOBADASER (16, 21), and a Norwegian study (22). Although other factors might influence the retention rates of TNF inhibitors, drug survival can be regarded as a surrogate marker for efficacy.…”

Section: Discussionsupporting

confidence: 93%

Drug Survival Rates of Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis

et al. 2014

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We investigated the compliance of Korean patients using tumor necrosis factor (TNF) inhibitors to treat rheumatoid arthritis (RA) and ankylosing spondylitis (AS), and identified potential predictors associated with treatment discontinuation. The study population comprised 114 RA and 310 AS patients treated with TNF inhibitors at a single tertiary center for at least 1 yr from December 2002 to November 2011. Of the 114 RA patients, 64 (56.1%) discontinued their first TNF inhibitors with a mean duration of 18.1 months. By contrast, 65 of 310 patients (21.0%) with AS discontinued their first TNF inhibitors, with a mean duration of 84 months. Although the survival rate did not differ among the three TNF inhibitors in the AS patients, the etanercept group had a lower discontinuation rate than the infliximab group in the RA patients. In addition, RA patients who received corticosteroids in combination with TNF inhibitors were more likely to discontinue their TNF inhibitors. The independent predictors of drug discontinuation in AS patients were male gender and complete ankylosis on radiographs of the sacroiliac joint. Our results provide further evidence that real-life treatment outcomes of RA and AS patients may be different from those observed in randomized clinical trials.Graphical Abstract

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Section: Discussionsupporting

confidence: 93%

Drug Survival Rates of Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis

et al. 2014

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“…More deaths were observed in ADA+MTX patients versus PBO+MTX patients, which is inconsistent with previous clinical trial experience 18. Advanced age and comorbidities have been reported in some analyses as risk factors for immunomodulatory therapy toxicity 19–22. Older patients were over-represented, with four of six deaths in the ADA+MTX arm occurring in patients over 70 years old.…”

Section: Discussionmentioning

confidence: 70%

Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study

et al. 2012

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ObjectiveTo assess the efficacy and safety of adalimumab plus methotrexate (ADA+MTX) compared with methotrexate monotherapy in achieving stable low disease activity (LDA; disease activity score (DAS28(CRP)) <3.2 at weeks 22 and 26) and clinical, radiographic and functional outcomes in methotrexate-naive patients with early rheumatoid arthritis (RA).Methods1032 patients with active RA were randomly assigned 1:1 to ADA+MTX or placebo plus methotrexate (PBO+MTX) for 26 weeks. Treatment modifications were to be made in a subsequent study period based on the achievement of DAS28(CRP) <3.2 at weeks 22 and 26. Post-hoc analyses compared patients achieving stable remission using DAS28 and 2010 ACR/EULAR criteria with those achieving LDA but not remission.ResultsAmong patients completing 6 months, 44% (207/466) ADA+MTX versus 24% (112/460) PBO+MTX patients achieved stable LDA at weeks 22 and 26 (p<0.001). Combination therapy was statistically superior to methotrexate in obtaining higher ACR20/50/70 responses, more clinical remissions, greater mean reductions in DAS28(CRP), no radiographic progression, and normal functional status at week 26 (p<0.001 for all). The only factor predicting stable LDA was disease activity at week 12. Patients achieving ACR/EULAR remission, particularly in the PBO+MTX group, had some advantage in radiographic outcomes compared with patients who only achieved LDA (but not remission). The overall frequency of adverse events was comparable between groups. There were more serious infections and deaths in the ADA+MTX group, with a possible age effect.ConclusionsTreatment with ADA+MTX was significantly superior to methotrexate alone with respect to clinical, radiographic and functional outcomes in patients with early active RA. Before initiating treatment with adalimumab, individual patient evaluation of the benefit/risk ratio should be carefully considered.

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“…On the other hand, TNF seems to be a more important cytokine in the AS mechanism than in RA. Better drug survival and lower rate of lack of efficacy and adverse event in AS and spondyloarthritis have been reported by other registry studies [22,23]. Several studies have evaluated causes of therapy discontinuation in RA, and the majority demonstrated a higher rate of inefficacy [7,24].…”

Section: Discussionmentioning

confidence: 86%

“…According to Brazilian guidelines, biological agents are the second line of treatment. Therefore, we have included AS patients whose anti-inflammatory 22 Universidade Estadual do Rio de Janeiro, Reumatologia, Rio de Janeiro, RJ, Brazil 23 Hospital de Base do Distrito Federal, Brasília, DF, Brazil 24 Department of Internal Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil 25 Division of Rheumatology, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil treatment failed and RA patients whose DMARD combination (at least two) failed [16,17].…”

Section: Methodsmentioning

confidence: 99%

Drug survival and causes of discontinuation of the first anti-TNF in ankylosing spondylitis compared with rheumatoid arthritis: analysis from BIOBADABRASIL

et al. 2015

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Treatment survival with biological therapy may be influenced by many factors, and it seems to be different among various rheumatic diseases and biological agents. The goal of the study was to compare the drug survival and the causes of discontinuation of anti-tumoral necrosis factor (anti-TNF) therapy in ankylosing spondylitis (AS) with rheumatoid arthritis (RA). Study participants were a cohort from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (BIOBADABRASIL) between 2008 and 2012. The observation time was up to 4 years following the introduction of the first treatment. Gender, age, disease duration, disease activity, comorbidities, and concomitant therapies were assessed. A total of 1303 patients were included: 372 had AS and 931 had RA in which 38.7 % (n = 504) used infliximab (IFX), 34.9 % (n = 455) used adalimumab (ADA), and 26.4 % (n = 344) used etanercept (ETA). The anti-TNF drug survival of patients with AS was 63.08 months (confidence interval (CI) 60.24, 65.92) and patients with RA was 47.5 months (CI 45.65, 49.36). It was significant higher in AS (log-rank; p ≤ 0.001). Patients with RA discontinued anti-TNF more than patients with AS when adjusted to gender and corticosteroid. The adjHR (95 % CI) was 1.6 (1.14, 2.31). Female patients who were also corticosteroid users, but not of advanced age, have shown lower survival for both diseases (log-rank, p ≤ 0.001). The discontinuation rate of IFX, but not of ADA or ETA, was significantly higher in RA than in SA; HR (95 % CI) was 2.49 (1.46, 4.24). The main causes of discontinuation were ineffectiveness and adverse event in both diseases. AS patients have better drug survival adjusted to gender, age, and corticosteroid. This results appear to be related to the disease mechanism.

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Age at treatment predicts reason for discontinuation of TNF antagonists: data from the BIOBADASER 2.0 registry

Abstract: In conclusion, factors predicting discontinuation of TNF antagonists due to AEs are older age and diagnosis of RA. On the other hand, younger age predicts discontinuation due to lack of efficacy.

Cited by 45 publications

References 17 publications

Drug Survival Rates of Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis

Drug Survival Rates of Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis

Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study

Drug survival and causes of discontinuation of the first anti-TNF in ankylosing spondylitis compared with rheumatoid arthritis: analysis from BIOBADABRASIL

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