Clinical response, drug survival and predictors thereof in 432 ankylosing spondylitis patients after switching tumour necrosis factor α inhibitor therapy: results from the Danish nationwide DANBIO registry

Glintborg, Bente; Østergaard, Mikkel; Krogh, Niels Steen; Tarp, Ulrik; Manilo, Natalia; Loft, Anne Gitte; Hansen, Annette; Schlemmer, Annette; Fana, Victoria; Lindegaard, Hanne; Nordin, Henrik; Rasmussen, Claus; Ejstrup, Leif; Jensen, Dorte Vendelbo; Petersen, Peter M.; Hetland, Merete Lund

doi:10.1136/annrheumdis-2012-201933

Cited by 125 publications

(113 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…An analysis of the DANBIO registry indicated that response (BASDAI 50) at 6 months reduced with subsequent anti-TNFs, as did the median improvement in BASDAI and BASFI achieved ( Table 22). 135 These results are supported by the RHAPSODY study that found higher response rates with adalimumab in anti-TNF naive patients (BASDAI 50-63%; ASAS 40-59%)(n = 924) than in anti-TNF exposed (BASDAI 50-41%; ASAS 40-38%) (n = 326). 136 The registries and cohort studies provided no data on the efficacy of anti-TNFs as second or third, after switching in nr-AxSpA patients.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 63%

“…The median drug survival in AS patients across all anti-TNFs reported varied (Table 21). Based on the largest registry (DANBIO) 135 the median drug survival for a first anti-TNF was 3.1 years (95% CI 2.6 to 3.7 years) (n = 1436), with 58% of patients remaining on treatment at 2 years. Median drug survival for a second anti-TNF was 1.6 years (95% CI 1.0 to 2.2 years) (n = 432), with 47% of patients remaining on treatment at 2 years, and for a third, 1.8 years (95% CI 0.9 to 2.7 years) (n = 137) (49% on treatment at 2 years).…”

Section: Drug Survival and Anti-tumour Necrosis Factor Switchingmentioning

confidence: 99%

See 1 more Smart Citation

Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Corbett

Soares

Jhuti

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

BackgroundTumour necrosis factor (TNF)-α inhibitors (anti-TNFs) are typically used when the inflammatory rheumatologic diseases ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-AxSpA) have not responded adequately to conventional therapy. Current National Institute for Health and Care Excellence (NICE) guidance recommends treatment with adalimumab, etanercept and golimumab in adults with active (severe) AS only if certain criteria are fulfilled but it does not recommend infliximab for AS. Anti-TNFs for patients with nr-AxSpA have not previously been appraised by NICE.ObjectiveTo determine the clinical effectiveness, safety and cost-effectiveness within the NHS of adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, within their licensed indications, for the treatment of severe active AS or severe nr-AxSpA (but with objective signs of inflammation).DesignSystematic review and economic model.Data sourcesFifteen databases were searched for relevant studies in July 2014.Review methodsClinical effectiveness data from randomised controlled trials (RCTs) were synthesised using Bayesian network meta-analysis methods. Results from other studies were summarised narratively. Only full economic evaluations that compared two or more options and considered both costs and consequences were included in the systematic review of cost-effectiveness studies. The differences in the approaches and assumptions used across the studies, and also those in the manufacturer’s submissions, were examined in order to explain any discrepancies in the findings and to identify key areas of uncertainty. A de novo decision model was developed with a generalised framework for evidence synthesis that pooled change in disease activity (BASDAI and BASDAI 50) and simultaneously synthesised information on function (BASFI) to determine the long-term quality-adjusted life-year and cost burden of the disease in the economic model. The decision model was developed in accordance with the NICE reference case. The model has a lifetime horizon (60 years) and considers costs from the perspective of the NHS and personal social services. Health effects were expressed in terms of quality-adjusted life-years.ResultsIn total, 28 eligible RCTs were identified and 26 were placebo controlled (mostly up to 12 weeks); 17 extended into open-label active treatment-only phases. Most RCTs were judged to have a low risk of bias overall. In both AS and nr-AxSpA populations, anti-TNFs produced clinically important benefits to patients in terms of improving function and reducing disease activity; for AS, the relative risks for ASAS 40 ranged from 2.53 to 3.42. The efficacy estimates were consistently slightly smaller for nr-AxSpA than for AS. Statistical (and clinical) heterogeneity was more apparent in the nr-AxSpA analyses than in the AS analyses; both the reliability of the nr-AxSpA meta-analysis results and their true relevance to patients seen in clinical practice are questionable. In AS, anti-TNFs are approximately equally effective. Effectiveness appears to be maintained over time, with around 50% of patients still responding at 2 years. Evidence for an effect of anti-TNFs delaying disease progression was limited; results from ongoing long-term studies should help to clarify this issue. Sequential treatment with anti-TNFs can be worthwhile but the drug survival response rates and benefits are reduced with second and third anti-TNFs. The de novo model, which addressed many of the issues of earlier evaluations, generated incremental cost-effectiveness ratios ranging from £19,240 to £66,529 depending on anti-TNF and modelling assumptions.ConclusionsIn both AS and nr-AxSpA populations anti-TNFs are clinically effective, although more so in AS than in nr-AxSpA. Anti-TNFs may be an effective use of NHS resources depending on which assumptions are considered appropriate.Future work recommendationsRandomised trials are needed to identify the nr-AxSpA population who will benefit the most from anti-TNFs.Study registrationThis study is registered as PROSPERO CRD42014010182.FundingThe National Institute for Health Research Health Technology Assessment programme.

show abstract

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 63%

Section: Drug Survival and Anti-tumour Necrosis Factor Switchingmentioning

confidence: 99%

Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Corbett

Soares

Jhuti

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

show abstract

“…Although the current study did not evaluate the reasons patients switched or discontinued TNFi therapy, previous studies have shown that approximately 30-36% of patients with AS, discontinued or switched biologic therapy because of adverse events [35,36] or lack of treatment effect [37]. Although no specific TNFi has been shown to be more effective than another in patients with AS [12,38], studies of TNFi treatment patterns provide better understanding of real-world use.…”

Section: Add-on Medication N (%)mentioning

confidence: 91%

Treatment patterns of biologics in US patients with ankylosing spondylitis: descriptive analyses from a claims database

et al. 2018

View full text Add to dashboard Cite

Aim: Examine treatment patterns among patients with active ankylosing spondylitis (AS) treated with a TNF inhibitor (TNFi). Patients & methods: Patients with AS who initiated a TNFi between 1 January 2013, and 31 January 2015, were identified in the Optum Research Database. Outcomes included adherence, persistence, discontinuation and therapy modifications of the index TNFi during 12-month follow-up. Results: Of the 426 patients included, 40.6% persisted on the index TNFi for ≥12 months, 31.0% discontinued, 21.4% switched to a different TNFi, and 7.0% discontinued and then restarted. Of the 333 patients who persisted on their TNFi for >90 days, 44.7% received ≥1 add-on medication. Conclusion: A high proportion of patients with AS switched, discontinued or modified their TNFi therapy.

show abstract

“…Most of the large phase III studies were done in AS patients who were biologicnaive, with most of the evidence relating to switching of TNF inhibitors in AS from observational or registry data. The available data suggest that switching to a second anti-TNF agent in AS can be effective, although response rates and drug survival were lower in switchers than those who did not switch (Lie et al, 2011;Glintborg et al, 2013). Until alternative effective biologic agents are available for the treatment of AS and axSpA, switching of TNF inhibitor will remain the only realistic option for patients who fail to respond adequately to their first anti-TNF agent.…”

Section: A Ankylosing Spondylitis and Axial Spondyloarthritismentioning

confidence: 99%

Cytokines as Therapeutic Targets in Rheumatoid Arthritis and Other Inflammatory Diseases

et al. 2015

View full text Add to dashboard Cite

Clinical response, drug survival and predictors thereof in 432 ankylosing spondylitis patients after switching tumour necrosis factor α inhibitor therapy: results from the Danish nationwide DANBIO registry

Abstract: Nearly one-third of AS patients in clinical practice switched biological treatment. Response rates and drug survivals were lower among switchers, however, half of switchers achieved treatment response.

Cited by 125 publications

References 35 publications

Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Treatment patterns of biologics in US patients with ankylosing spondylitis: descriptive analyses from a claims database

Cytokines as Therapeutic Targets in Rheumatoid Arthritis and Other Inflammatory Diseases

Contact Info

Product

Resources

About