Adherence to recommendations for the use of anti-tumour necrosis factor and its impact over 5 years of follow-up in axial spondyloarthritis.

Un nouvel article scientifique intitulé «Adherence to recommendations for the use of anti-tumour necrosis factor and its impact over 5 years of follow-up in axial spondyloarthritis.» a été publié dans le journal Rheumatology (Oxford).

López-Medina C, Dougados M, Collantes-Estévez, Moltó A.

Abstract

OBJECTIVES:
To describe adherence to recommendations for TNFα blocker (TNFb) initiation and continuation in early axial Spondyloarthropathy (axSpA); and to evaluate the impact of adherence to these recommendations over 5 years of follow-up in the DEvenir des Spondyloarthrites Indifférenciées Récentes (DESIR) cohort.

METHODS:
The first 5 years of follow-up of the DESIR early axSpA cohort were analysed. We evaluated adherence to Assessment of SpondyloArthritis International Society (ASAS) 2003/2006, 2016 and European Medicines Agency recommendations in axSpA patients for: TNFb initiation (patients were adherent if they either commenced TNFb therapy when they met the conditions for initiation or if they did not commence TNFb therapy when conditions were not met) and; TNFb continuation (either when they continued TNFb therapy when conditions to continue were met or when they discontinued when conditions were not met). The impact of adherence to these recommendations on functional disability, quality of life and sick-leave days over 5 years was explored.

RESULTS:
A total of 708 patients were analysed: 440 (62.15%), 389 (54.94%) and 335 (47.32%) were considered adherent to ASAS 2003/2006, 2016 and European Medicines Agency recommendations for TNFb initiation, respectively. Adherence to 2003/2006 and 2016 recommendations for TNFb continuation was observed in 47.37 and 49.39% of patients, respectively. According to over 5 years of follow-up, better outcomes (lower BASFI, higher SF-36 and fewer days of sick leave) were found in patients adhering to recommendations for TNFb commencement and continuation.

CONCLUSION:
Less than 50% of patients were treated in agreement with recommendations for TNFb initiation and continuation. Nevertheless, adherence to such recommendations leads to better functional outcomes and fewer days of sick leave, according to long-term follow-up.

Newsletter Radiologues N°6

Bonjour,
Nous mettons en ligne aujourd’hui la nouvelle Newsletter rhumatologues rédigée par le Dr A. Feydy, rhumatologue à Cochin .
Pour y avoir accès, merci de consulter le lien suivant: cliquer ici.

Newsletter Rhumatologues N°27

Bonjour,
Nous mettons en ligne aujourd’hui la nouvelle Newsletter rhumatologues rédigée par le Pr F Berenbaum, rhumatologue à Saint Antoine .
Pour y avoir accès, merci de consulter le lien suivant: cliquer ici.

Newsletter Patient N°18

Bonjour,
Nous mettons en ligne aujourd’hui la nouvelle Newsletter patients rédigée par le Pr C Miceli, rhumatologue au CHU de Cochin.
Pour y avoir accès, merci de cliquer ici.

Newsletter Patient N°17

Nous mettons en ligne aujourd’hui la nouvelle Newsletter patients rédigée par le Pr L. Gossec, rhumatologue au CHU La pitié Salpêtrière.
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Newsletter Patient N°16

Bonjour,
Nous mettons en ligne aujourd’hui la nouvelle Newsletter patients rédigée par le Pr P Claudepierre , rhumatologue au CHU Henri Mendor.
Pour y avoir accès, merci de cliquer ici.

Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis

Un nouvel article scientifique intitulé «Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis.» a été publié dans le journal Ann Rheum Dis .

Dougados M, Maksymowych W, Landewé RB, Moltó A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D.

Abstract

OBJECTIVE:

To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR).

METHODS:

Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates.

RESULTS:

At 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: -0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was -0.22 (95% CI -0.38 to -0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: -1.9% versus 1.6% (adjusted difference for etanercept minus control: -4.7%,95% CI -9.9 to 0.5, p=0.07) for change in mNY criteria; -1.9% versus 7.8% (adjusted difference: -18.2%,95% CI -30.9 to -5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and -0.6% versus 6.7% (adjusted difference: -16.4%,95% CI -27.9 to -5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change.

CONCLUSION:

Despite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy.
TRIAL REGISTRATION NUMBERS:

NCT01258738,NCT01648907; Post-results.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

KEYWORDS:

anti-tnf; spondyloarthritis; treatment

Access criteria for anti-TNF agents in spondyloarthritis: influence on comparative 1-year cost-effectiveness estimates.

Un nouvel article scientifique intitulé «Access criteria for anti-TNF agents in spondyloarthritis: influence on comparative 1-year cost-effectiveness estimates.» a été publié dans le journal Cost Eff Resour Alloc.

Harvard S, Guh D, Bansback N, Richette P, Saraux A, Fautrel B, Anis A.

Abstract

BACKGROUND:
Anti-tumor necrosis factor (anti-TNF) agents are an effective, but costly, treatment for spondyloarthritis (SpA). Worldwide, multiple sets of access criteria aim to restrict anti-TNF therapy to patients with specific clinical characteristics, yet the influence of access criteria on anti-TNF cost-effectiveness is unknown. Our objective was to use data from the DESIR cohort, a prospective study of early SpA patients in France, to determine whether the French anti-TNF access criteria are the most cost-effective in that setting relative to other potential restrictions.

METHODS:
We used data from the DESIR cohort to create five study populations of patients meeting anti-TNF access criteria from Canada, France, Germany, United Kingdom, and Hong Kong, respectively. For each study population, we calculated the costs and quality-adjusted life years (QALYs) over 1 year of patients treated and not treated with anti-TNF therapy. To control for differences between anti-TNF users and non-users, we used linear regression models to derive adjusted mean costs and QALYs. We calculated incremental cost-effectiveness ratios (ICERs) representing the incremental cost per additional QALY gained by treating with an anti-TNF within each of the five study populations, using bootstrapping to explore the range of uncertainty in costs and QALYs. A series of sensitivity analyses was conducted, including one to simulate the effect of a 24-week stopping rule for anti-TNF non-responders.

RESULTS:

Anti-TNF access criteria from France were satisfied by the largest proportion of DESIR patients (27.8%), followed by Germany (25.1%), Canada (23.8%), the UK (12.1%) and Hong Kong (8.6%). Confidence intervals around incremental costs and QALYs in the basecase analysis were overlapping, indicating that anti-TNF cost-effectiveness estimates derived from each subset were similar. In the sensitivity analysis that examined the effect of excluding costs accumulated past 24 weeks by anti-TNF non-responders, the incremental cost per QALY was reduced by approximately 25% relative to the basecase analysis (France: €857,992 vs. €1,105,859; Canada: € 626,459 vs. €818,186; Germany: € 422,568 vs. €545,808); UK €578,899 vs. €766,217; Hong Kong €335,418 vs. €456,850).

CONCLUSIONS:

Anti-TNF cost-effectiveness is strongly affected by treatment continuation among non-responders. Access criteria could improve anti-TNF cost-effectiveness by defining patients likely to respond.

KEYWORDS:

Anti-TNF; Biologics; Cost-effectiveness; Pharmaceutical policy; Spondyloarthritis

Relationships between ultrasound enthesitis, disease activity and axial radiographic structural changes in patients with early spondyloarthritis: data from DESIR cohort

Un nouvel article scientifique intitulé «Relationships between ultrasound enthesitis, disease activity and axial radiographic structural changes in patients with early spondyloarthritis: data from DESIR cohort.» a été publié dans le journal RMD Open.

Ruyssen-Witrand A, Jamard B, Cantagrel A, Nigon D, Loeuille D, Degboe Y, Constantin A.

Abstract

BACKGROUND:

To search for association between ultrasound (US) enthesis abnormalities and disease activity, spine and sacro-iliac joints (SIJ) MRI inflammatory lesions and spine structural changes in a cohort of patients suspected for axial spondyloarthritis (SpA).

METHODS:

Patients: Of 708 patients included in the DESIR(Devenir des Spondyloarthrites Indifférenciées Récentes) cohort, 402 had an US enthesis assessment and were selected for this study. Imaging: Achilles, lateral epicondyles, superior patellar ligament, inferior patellar ligament entheses were systematically US scanned and abnormalities were summed in US structural and power Doppler (PDUS) scores. Spine radiographs, SIJ and spine MRI scans were centrally scored modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), presence of MRI sacro-iliitis, Spondyloarthritis Research Consortium of Canada and Berlin scores. Analysis: The associations between the US structural/PDUS scores and disease activity, C reactive protein (CRP), MRI SIJ and spine inflammatory lesions and mSASSS were tested by Spearman’s correlation tests.

RESULTS:

Among the 402 patients included (median age: 33.5 years, males: 48.5%), 55% had US enthesis structural abnormalities while 14% had PDUS abnormalities. There was no association between US scores and Bath Ankylosing Spondylitis Disease Activity Index, CRP or inflammatory lesions on SIJ and spine MRI. There was a correlation between US structural and PDUS scores and the mSASSS (respectively, r=0.151, p=0.005; r=0.143, p=0.007). The proportion of patients with syndesmophytes was higher in the case of US enthesophytes (26% of syndesmophytes vs 6% in the absence of US enthesophytes, p<0.0001).

CONCLUSION:

While the US abnormalities do not seem to be a helpful tool for monitoring disease activity in axial SpA, US enthesophytes, strongly associated with axial syndesmophytes, might be a marker of interest for disease severity.
TRIAL REGISTRATION NUMBER:

NCT01648907, date of registration : 20 July 2012.

KEYWORDS:

sacro-iliitis; spondyloarthritis; syndesmophytis; ultrasound

Adherence to Antitumor Necrosis Factor Use Recommendations in Spondyloarthritis: Measurement and Effect in the DESIR Cohort

Un nouvel article scientifique intitulé «Adherence to Antitumor Necrosis Factor Use Recommendations in Spondyloarthritis: Measurement and Effect in the DESIR Cohort.» a été publié dans le journal J Rheumatol.

Harvard S, Guh D, Bansback N, Richette P, Saraux A, Fautrel B, Anis AH.

Abstract

OBJECTIVE:

To evaluate a classification system to define adherence to axial spondyloarthritis (axSpA) anti-tumor necrosis factor (anti-TNF) use recommendations and examine the effect of adherence on outcomes in the DESIR cohort (Devenir des Spondylarthropathies Indifférenciées Récentes).

METHODS:

Using alternate definitions of adherence, patients were classified as adherent « timely » anti-TNF users, nonadherent « late » anti-TNF users, adherent nonusers ( »no anti-TNF need »), non-adherent nonusers ( »unmet anti-TNF need »). Multivariate models were fitted to examine the effect of adherence on quality-adjusted life-years (QALY), total costs, and nonbiologic costs 1 year following an index date. Generalized linear regression models assuming a γ-distribution with log link were used for costs outcomes and linear regression models for QALY outcomes.

RESULTS:

Using the main definition of adherence, there were no significant differences between late anti-TNF users and timely anti-TNF users in total costs (RR 0.86, 95% CI 0.54-1.36, p = 0.516) or nonbiologic costs (RR 0.72, 95% CI 0.44-1.18, p = 0.187). However, in the sensitivity analysis, late anti-TNF users had significantly increased nonbiologic costs compared with timely users (RR 1.58, 95% CI 1.06-2.36, p = 0.026). In the main analysis, there were no significant differences in QALY between timely anti-TNF users and late anti-TNF users, or between timely users and patients with unmet anti-TNF need. In the sensitivity analysis, patients with unmet anti-TNF need had significantly lower QALY than timely anti-TNF users (-0.04, 95% CI -0.07 to -0.01, p = 0.016).

CONCLUSION:

The effect of adherence to anti-TNF recommendations on outcomes was sensitive to the definition of adherence used, highlighting the need to validate methods to measure adherence.

KEYWORDS:

ADHERENCE; ANKYLOSING SPONDYLITIS; ANTI-TNF; ECONOMIC; QUALITY OF LIFE; SPONDYLOARTHRITIS