Deciding who to treat with biologic disease-modifying antirheumatic drugs in axial spondyloarthritis

Immunotherapy ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 857-860
Author(s):  
Daniel Wendling ◽  
Philippe Goupille
Author(s):  
Denis Poddubnyy ◽  
Hildrun Haibel

In axial spondyloarthritis (axSpA) there is little evidence to support use of classical synthetic disease-modifying antirheumatic drugs (DMARDs), with the majority of studies performed in advanced ankylosing spondylitis. Sulfasalazine is the best investigated DMARD in axSpA. Its positive clinical effect, if any, seems to be more prominent in the presence of peripheral arthritis, although a certain proportion of patients with axial disease might benefit from sulfasalazine therapy. Available data indicate that there is no evidence that methotrexate might be effective in axial disease, and only marginal evidence exists in support of methotrexate use in case of peripheral involvement. No true disease-modifying properties (e.g. retardation of structural damage progression in the spine) have been demonstrated for DMARDs in axSpA to date. Efficacy of a combination therapy (e.g. methotrexate plus sulfasalazine) as well as benefits of methotrexate (or other DMARDs) in addition to tumour necrosis factor α‎ inhibitors in axSpA remain uncertain.


RMD Open ◽  
2017 ◽  
Vol 3 (2) ◽  
pp. e000524 ◽  
Author(s):  
Victoria Navarro-Compán ◽  
Chamaida Plasencia-Rodríguez ◽  
Eugenio de Miguel ◽  
Petra Diaz del Campo ◽  
Alejandro Balsa ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028517 ◽  
Author(s):  
Line Uhrenholt ◽  
Annette Schlemmer ◽  
Ellen-Margrethe Hauge ◽  
Robin Christensen ◽  
Lene Dreyer ◽  
...  

IntroductionThe The BIOlogical Dose OPTimisation (BIODOPT) trial is a pragmatic, multicentre, randomised controlled, open-label, parallel-group, equivalence study designed to evaluate tapering of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) in sustained clinical remission or low disease activity (LDA). Traditionally, these patients maintain standard dosage of bDMARD lifelong; however, recent studies indicate that a significant proportion of patients in sustained remission or LDA can taper their bDMARD and maintain stable disease activity. Thus, this trial aims to evaluate whether a disease activity-guided tapering strategy for bDMARDs will enable a significant dosage reduction while maintaining disease activity compared with usual care. From the individual patient’s standpoint as well as from a societal perspective, it would be advantageous if bDMARDs could be reduced or even discontinued while maintaining disease activity.Methods and analysisA total of 180 patients with RA, PsA or axSpA treated with bDMARDs and in clinical remission/LDA during the past 12 months will be enrolled from four centres in Denmark. Patients will be randomised in a ratio of 2:1 to either disease activity-guided tapering of bDMARDs (intervention group) or continuation of bDMARDs as usual care (control group).The primary objective is the difference between the two groups in the proportion of patients who have reduced their inclusion dosage of bDMARDs to 50% or less while maintaining stable disease activity at 18 months follow-up.Ethics and disseminationThe study is approved by the ethics committee of Northern Jutland, Denmark (N-20170073) and by the Danish Medicine Agency. Patient research partner KHH contributed to refinement of the protocol and approved the final manuscript. Results will be disseminated through publication in international peer-reviewed journals.Trial registration number2017-001970-41; Pre-results.


RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001145 ◽  
Author(s):  
Jose Marona ◽  
Alexandre Sepriano ◽  
Santiago Rodrigues-Manica ◽  
Fernando Pimentel-Santos ◽  
Ana Filipa Mourão ◽  
...  

ObjectivesTo compare definitions of high disease activity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in selecting patients for treatment with biologic disease-modifying antirheumatic drugs (bDMARDs).MethodsPatients from Rheumatic Diseases Portuguese Register (Reuma.pt) with a clinical diagnosis of axial spondyloarthritis (axSpA) were included. Four subgroups (cross-tabulation between ASDAS (≥2.1) and BASDAI (≥4) definitions of high disease activity) were compared regarding baseline characteristics and response to bDMARDs at 3 and 6 months estimated in multivariable regression models.ResultsOf the 594 patients included, the majority (82%) had both BASDAI≥4 and ASDAS ≥2.1. The frequency of ASDAS ≥2.1, if BASDAI<4 was much larger than the opposite (ie, ASDAS <2.1, if BASDAI≥4): 62% vs 0.8%. Compared to patients fulfilling both definitions, those with ASDAS ≥2.1 only were more likely to be male (77% vs 51%), human leucocyte antigen B27 positive (79% vs 65%) and have a higher C reactive protein (2.9 (SD 3.5) vs 2.1 (2.9)). Among bDMARD-treated patients (n=359), responses across subgroups were globally overlapping, except for the most ‘stringent’ outcomes. Patients captured only by ASDAS responded better compared to patients fulfilling both definitions (eg, ASDAS inactive disease at 3 months: 61% vs 25% and at 6 months: 42% vs 25%).ConclusionThe ASDAS definition of high disease activity is more inclusive than the BASDAI definition in selecting patients with axSpA for bDMARD treatment. The additionally ‘captured’ patients respond better and have higher likelihood of predictors thereof. These results support using ASDAS≥2.1 as a criterion for treatment decisions.


2009 ◽  
Vol 29 (04) ◽  
pp. 205-213
Author(s):  
M. Pierer ◽  
U. Wagner ◽  
C. Baerwald ◽  
O. Malysheva

ZusammenfassungRheumatische Erkrankungen sind schwere Erkrankungen, die mit anhaltenden Schmerzen einhergehen, zum Verlust an Lebensqualität, Funktion, Arbeitsfähigkeit und auch zur Verkürzung des Lebens führen können. Sie verursachen erhebliche Kosten für das Gesundheitssystem. Mehrere Biologika als neue „disease modifying antirheumatic drugs“ sind in die Therapie von rheumatoider Arthritis, Spondyloarthropathien, Psoriasis-Arthritis und idiopathischer juveniler Arthritis eingeführt worden. Es fand sich eine zum Teil große Effektivität der Biologika, wobei dieser Artikel sich auf die Anti-TNF-Therapien, nämlich Adalimumab, Etanercept und Infliximab, konzentriert. Weitere Anti-TNF Therapien sind in Entwicklung. Mit deren Zulassung ist in den nächsten Monaten zu rechnen.


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