The immunogenicity to the first anti-TNF therapy determines the outcome of switching to a second anti-TNF therapy in spondyloarthritis patients

Plasencia, C.; Pascual‐Salcedo, Dora; García-Carazo, S.; Lojo, L.; Nuño, Laura; Villalba, A.; Peiteado, Diana; Arribas, F.; Díez, Jesús; López-Casla, M. T.; Martı́n-Mola, Emilio; Balsa, Alejandro

doi:10.1186/ar4258

Cited by 61 publications

(32 citation statements)

References 46 publications

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“…The chimeric monoclonal antobody induces production of anti-drug antibodies more intensively than the humanised ones (adalimumab and golimumab) and the receptor fusion protein etanercept. It was published recently, that in patients with spondyloarthropathies antidrug antibodies could be detected in 25.9% of patients, most frequently in infliximab treated ones (81.8%) compared to those ones treated with adalimumab (18.2%) and etanercept (0%) (26). As these anti-drug antibodies are responsible for treatment failures at least in some of the cases, it may support the validity of our results.…”

Section: Discussionsupporting

confidence: 86%

Real-life experience with switching TNF-α inhibitors in ankylosing spondylitis

et al. 2014

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Objective: The aim of this study was to evaluate efficacy, reasons for switching and drug survival of TNF-α inhibitors (TNFi-s) used as first and second line drugs in ankylosing spondylitis (AS).Methods: Data of patients suffering from AS and treated with at least one TNFi between November 2005 and November 2013 were extracted retrospectively from the database of one clinical center. Beside demographic data, the disease activity measured by BASDAI, the response rates (BASDAI50), reasons for switching and survival curves of TNFi-s were analyzed in general and in subgroups of patients treated with each of the available TNFi-s. The reasons for switching were defined as inefficacy, side effect of the given drug, patient's request, and occurence of extra-articular manifestations.Results: Altogether 175 patients were on TNFi and 77 of them received at least 2 TNFi-s. The patients' age at the initiation of the first TNFi was higher among switchers compared to nonswitchers (42.5±12.6 vs 38.8±11.2 years, p=0.049), otherwise gender, disease duration and initial disease activity had no influence on the risk of switching. The decrease of BASDAI was similar among non-switchers and switchers either using the first or second TNFi, but the response rates to the first and second TNFi were worse in switchers than in non-switchers. Following the failure of first TNFi, the retention on therapy was unfavourable, especially in patients on infliximab after one year of treatment. The main reason for switching from the first drug was inefficacy. The frequency of side effects that led to switching was higher in the infliximab group than in patiets treated with other agents. Conclusion:Although the retention rate to a second line TNFi was somewhat worse than that to the first line TNFi, switching of TNFi-s is a good therapeutic option is AS patients who failed to respond to the first TNFi.

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Section: Discussionsupporting

confidence: 86%

Real-life experience with switching TNF-α inhibitors in ankylosing spondylitis

et al. 2014

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“…Moreover, no significant differences were found between drug levels and clinical status in RA and SpA classified by DAS28 or BADSAI score; furthermore, no significant difference was observed in the clinical response of anti-drug Ab positive and negative subjects of each disease group. Most of the studies refer that therapy failure occurred more frequently in positive anti-drug Ab patients [3,32,37,39], although there are previous reports which did not find a similar relation [40][41][42]. It is also reported that the concomitant use of MTX with anti-TNFα drugs reduces the incidence of anti-drug Ab [6,36]; in our study, in agreement with opposite results [13,39] concomitant MTX therapy was irrelevant on anti-drug Ab development.…”

Section: Discussionsupporting

confidence: 86%

“…Anti-drug Ab are generally reported as detected in up to one third of RA and about 25% of SpA patients [2,[30][31][32][33]. Chimericdrugs (mouse-human), such as IFX, have a greater likelihood of inducing anti-drug Abs production compared to fully human antibodies [34,35].…”

Section: Discussionmentioning

confidence: 99%

Biologic therapies in rheumatic diseases: drug and anti-drug antibody levels and clinical efficacy

Lombardi¹,

Bernardoni²,

Bertolucci³

et al. 2017

J Autoimmun Cell Response

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Background: The aim of this study was to evaluate the relevance of drug and anti-drug antibody detection in the clinical management of patients with rheumatoid arthritis (RA) and spondyloarthropaties (SpA) in treatment with anti-tumor necrosis factor alpha (TNFα) biologics. Methods and results:The study included 192 adult consecutive patients treated for at least 6 months with adalimumab (ADA) or etanercept (ETN) or infliximab (IFX); patients underwent clinical observations in the Rheumatologic Unit of 5 Hospitals in Tuscany. Their demographic and clinical characteristics to calculate DAS28 and BASDAI scores were collected. Drug levels and anti-drug antibodies (anti-drug Ab) were evaluated immediately before drug injection or infusion. A total of 192 patients were studied: 62 receiving IFX, 64 ADA, and 66 ETN with a mean age of 57 years (range 18-86 years); the study group was composed of 51% women. Forty percent of the patients were affected by RA, 60% by SpA. Altogether, 81% of patients demonstrated therapeutic drug levels. Anti-drug Ab were found in 19% of patients taking IFX, 10% taking ETN and 5% taking ADA. No significant correlation was found between anti-drug Ab presence and low drug levels, between anti-drug Ab and high DAS28 and BASDAI scores, as well as between low drug levels and high DAS28 and BASDAI scores. Conclusions: Low drug levels were found in 19% of the rheumatic patients and there were not correlations with presence of anti-drug Ab or patient's clinical status.

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“…Nishimoto et al found ADAs in 4/306 patients (2.5%) in the SAMOURAI study; 1 had a drug infusion-associated reaction (skin rash) [30]. The proportion of patients with ADAs is thus very low as compared with that for patients receiving IFX [16,[31][32][33] or adalimumab [1,3,34], from 6% to 87%.…”

Section: Discussionmentioning

confidence: 93%