An Assessment in SpondyloArthritis International Society (ASAS)-endorsed definition of clinically important worsening in axial spondyloarthritis based on ASDAS

Moltó, Anna; Gossec, Laure; Meghnathi, Bhowmik; Landewé, Robert; Heijde, Desirée van der; Atagündüz, Pamir; Elzorkany, Bassel; Akkoç, Nurullah; Kiltz, Uta; J, Gu; Wei, James Cheng‐Chung; Dougados, Maxime

doi:10.1136/annrheumdis-2017-212178

Cited by 61 publications

(54 citation statements)

References 7 publications

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“…In the dermatological domain, clear cut-off values for important worsening are lacking for mBSA and treatment is adjusted as judged by the treating rheumatologist and patient, since this is a very individual choice. AxSpA flare is defined as an increase in ASDAS ≥ 0.9 (the published MCIW for ASDAS) [31,32]. We consider our flare criteria rather sensitive and therefore think we can detect any significant flare.…”

Section: Definition Of Flarementioning

confidence: 99%

Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial

Michielsens¹,

Boers

Broeder

et al. 2020

Trials

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Background: Tumour necrosis factor inhibitors (TNFi) are effective in the treatment of patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). However, these drugs come with some disadvantages such as adverse events, practical burden for patients and high costs. Dose optimisation of TNFi after patients have reached low disease activity (LDA) has been shown feasible and safe in rheumatoid arthritis (RA). However, data on TNFi dose optimisation in PsA and axSpA are scarce, especially pragmatic, randomised strategy studies. Methods: We developed an investigator-driven, pragmatic, open-label, randomised, controlled, non-inferiority trial (DRESS-PS) to compare the effects of a disease activity-guided treat-to-target strategy with or without a tapering attempt in patients with SpA (PsA and axSpA combined), ≥ 16 years of age, who are being treated with TNFi, and have had at least 6 months of low disease activity. The primary outcome is the percentage of patients in LDA after 12 months of follow up. Patients are assessed at baseline, 3, 6, 9, and 12 months of follow up. Bayesian power analyses with a weakened prior based on a similar study performed in RA resulted in a sample size of 95 patients in total. Discussion: More knowledge on disease activity-guided treatment algorithms would contribute to better treatment choices and cost savings and potentially decrease the risk of side effects. In this article we elucidate some of our design choices on TNFi dose optimisation and its clinical and methodological consequences.

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Section: Definition Of Flarementioning

confidence: 99%

Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial

Michielsens¹,

Boers

Broeder

et al. 2020

Trials

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“…At baseline, sex, age at diagnosis, time since diagnosis, HLA-B27 status, smoking status, and history of extraarticular manifestations (uveitis, psoriasis, inflammatory bowel disease, peripheral arthritis, and enthesitis) were recorded. Disease activity was assessed using the Ankylosing Spondylitis Disease Activity Score (ASDAS) according to CRP level [20]. Of the total sample, 253 patients who were followed for 2 years were assessed for radiographic progression.…”

Section: Materials and Methods Patientsmentioning

confidence: 99%

Association of Uveitis with Radiographic Progression in Patients with Axial Spondyloarthritis: A Propensity Score Matching Analysis

2019

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Objective. Acute anterior uveitis (AAU) is the most common extra-articular manifestation in patients with axial spondyloarthritis (axSpA). However, the relationship between AAU and radiographic progression in axSpA remains unclear. Hence, we investigated whether the presence of AAU is associated with radiographic structural damage in patients with axSpA. Methods. Clinical and radiographic data were obtained from 253 patients with axSpA. Radiographic progression over 2 years was assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Progression was defined as mSASSS worsening by ≥two units. Using propensity score (PS) matching, differences between patients with and without AAU were analyzed. Results. The proportion of progressors among patients with AAU was lower than that of patients without AAU (13.6% vs. 29.5%, p=0.058). The rate of increase in mSASSS and number of syndesmophytes were lower in patients with AAU than patients without AAU (0.57±1.37 vs. 1.02±1.79, p=0.085 and 0.46±1.45 vs. 0.83±1.62, p=0.158). In multivariate regression analysis, presence of AAU was independently associated with slowed radiographic progression (odds ratio [95% confidence interval] 0.21 [0.07, 0.67], p=0.004). Conclusion. PS-matched axSpA patients with AAU showed significantly less radiographic progression than those without AAU. (J Rheum Dis 2019;26:248-256)

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“…For instance, if a patient experienced a severe adverse event by the time of discontinuation, this was selected as main reason even if ASDAS-An alternative de nition of secondary failure to the rst TNFi was used in a sensitivity analysis. A patient was considered to have a secondary failure if he/she experienced a are (ASAS de nition, 0.9 point increase in ASDAS between two consecutive timepoints), [15] comparing to the immediately preceding visit (or to 2 previous visits, if the preceding was missing for ASDAS), at least once, after achieving ASDAS-CII at 3 or 6 months.…”

Section: Reason To Discontinue Tnfimentioning

confidence: 99%

Effectiveness of switching between TNF inhibitors in patients with axial spondyloarthritis: is the reason to switch relevant?

Manica

Sepriano

Pimentel-Santos

et al. 2020

Preprint

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Background: To investigate whether the reason to discontinue the first TNF inhibitor (TNFi) affects the response to a second TNFi in axial spondyloartrhtis (axSpA).Methods: Patients with axSpA from the Rheumatic Diseases Portuguese Register (ReumaPt), who discontinued their first TNFi and started a second TNFi between June 2008 and May 2018 were included. Response was assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement (ASDAS-CII), major important improvement (ASDAS-MI), low disease activity (ASDAS-LDA) and inactive disease (ASDAS-ID). The reason for discontinuation of the first TNFi was defined, according to ASDAS-CII as: primary failure (no response ≤6 months); secondary failure (response ≤6 months but lost thereafter); adverse events; other. The association between the reason of discontinuation of the first TNFi and response to the second TNFi over time was assessed in multivariable generalized equation (GEE) models.Results: In total, 193 patients were included. The reason of discontinuation of the first TNFi did not influence the response to a second TNFi, according to the ASDAS-CII. However, a difference was found with more stringent outcomes, e.g. there was a higher likelihood to achieve ASDAS-ID with the second TNFi for patients discontinuing the first TNFi due to secondary failure (OR: 7.3 [(95%CI: 1.9; 27.7]), adverse events (OR: 9.1 [2.5; 33.3]), or other reasons (OR: 7.7 [1.6; 37.9]) compared to primary failure.Conclusion: Patients with axSpA with secondary failure to their first TNFi, compared to those with primary failure, have better response to the second TNFi according to stringent outcomes.

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An Assessment in SpondyloArthritis International Society (ASAS)-endorsed definition of clinically important worsening in axial spondyloarthritis based on ASDAS

Abstract: This data-driven ASAS consensus process resulted in an ASDAS-based cut-off value defining clinically important worsening in axSpA for use in trials.

Cited by 61 publications

References 7 publications

Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial

Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial

Association of Uveitis with Radiographic Progression in Patients with Axial Spondyloarthritis: A Propensity Score Matching Analysis

Effectiveness of switching between TNF inhibitors in patients with axial spondyloarthritis: is the reason to switch relevant?

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