Registries in Spondyloarthritis: What have we Learned?

Ziadé, Nelly

doi:10.15406/mojor.2017.09.00347

Cited by 2 publications

(2 citation statements)

References 8 publications

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“…Moreover, further clinical outcomes are used in real-life studies, for example treatment persistence, i.e., a comprehensive outcome involving effectiveness and safety, mixed with patient and doctor satisfaction and preferences (7)(8)(9). For these reasons, real-world studies are central to integrate evidence from RCTs, as it was shown in Registry-based studies of patients with psoriasis and spondyloarthritis (SpA) (10)(11)(12)(13). 7 PsABio study is an international, prospective, observational cohort study aimed to evaluate the persistence, effectiveness, and safety of 1st/2nd/3rd-line ustekinumab versus TNFi in a real-life setting of adult PsA patients.…”

Section: Introductionmentioning

confidence: 99%

Persistence, effectiveness and safety of ustekinumab compared to TNF inhibitors in psoriatic arthritis within the Italian PsABio cohort

Gremese

Ciccia

Selmi

et al. 2022

Clinical and Experimental Rheumatology

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Objective. To compare real-world persistence, effectiveness and tolerability of ustekinumab versus TNF inhibitors (TNFi) in psoriatic arthritis (PsA).Methods. One-year data from Italian subjects enrolled in the PsABio study (PsA patients receiving 1st-to 3rd-line treatment with ustekinumab or TNFi) were evaluated.Treatment persistence was analysed using Kaplan-Meier curves; hazard ratios (HR) of stopping treatment, and the corresponding 95% confidence intervals (CI), were computed through Cox regression models. Proportions of patients reaching clinical effectiveness endpoints were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation if treatment was stopped/switched.Results. Among 222 participants with follow-up data (effectiveness set), 101 received ustekinumab and 121 TNFi. In the ustekinumab group, 74.3% continued treatment up to 12±3 months compared to 63.6% in the TNFi group. Ustekinumab showed better persistence than TNFi, overall and in specific subgroups (females, monotherapy without methotrexate, BMI <25 or >30 kg/m 2 , patients receiving ustekinumab as 2nd-line treatment instead of a second TNFi). Overall, the PS-adjusted HR of treatment discontinuation was 0.46 (95% CI: 0.26-0.82) for ustekinumab vs TNFi. cDAPSA LDA/remission was achieved in 43.5% of ustekinumab and 43.6% of TNFi-treated patients, while MDA was achieved in 24.2% and 28.0% of patients, respectively. After PS adjustment, odds ratios of clinical effectiveness did not differ significantly. Both treatments showed an acceptable safety profile.5 Conclusion. This prospective, real-life study found a better persistence of ustekinumab than TNFi in PsA patients. At 1 year, both treatments showed similar effectiveness.

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Section: Introductionmentioning

confidence: 99%

Persistence, effectiveness and safety of ustekinumab compared to TNF inhibitors in psoriatic arthritis within the Italian PsABio cohort

Gremese

Ciccia

Selmi

et al. 2022

Clinical and Experimental Rheumatology

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“…Observational registries and large-scale real-world studies are powerful tools for the exploration of these topics and improvement of knowledge in areas not covered by clinical trials (12). Registries in SpA or its subtypes, situated in Europe and the Americas (13,14), have usually involved patients with longstanding disease and severe disease expression, markedly receiving biologics at enrollment. Patients with mild to moderate SpA or treatment naïve are typically underrepresented.…”

Section: Introductionmentioning

confidence: 99%

An Italian Disease-Based Registry of Axial and Peripheral Spondyloarthritis: The SIRENA Study

et al. 2021

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Introduction: Data about the clinical presentation and management of early and mild spondyloarthritis (SpA) are limited.Objectives: The objective of this study was to describe the baseline characteristics of disease-modifying antirheumatic drug (DMARD)-naïve patients with axial or peripheral SpA.Methods: The Spondyloarthritis Italian Registry: Evidence from a National Pathway (SIRENA) study is an ongoing, Italian, multicenter, prospective registry of patients with a first or newly confirmed diagnosis of SpA according to the Assessment of SpondyloArthritis International Society (ASAS) criteria. To be included, patients had to be naïve to conventional, targeted, and biological DMARDs for SpA. Patients were enrolled between June 2017 and June 2019 and classified into groups according to disease presentation: predominantly axial or peripheral manifestations. The study is ongoing, and patients are being followed for 2 years, with an evaluation every 6 months according to clinical practice. Differences in baseline demographics, lifestyle, and clinical characteristics between axial and peripheral SpA were evaluated.Results: In this study, 350 patients were enrolled, of which 123 (35.1%) were axial and 227 (64.9%) were peripheral patients. Patients with axial SpA were significantly younger at enrollment (median age: 44 vs. 53 years), had significantly more anxiety/depression (13 vs. 2.6%), and expressed higher disease activity compared to patients with peripheral SpA. Patients with peripheral SpA had significantly more cardiometabolic disorders (33 vs. 18.7%), skin psoriasis (65.2 vs. 21.1%), and nail psoriasis (35.5 vs. 17.1%) than patients with axial SpA. Dactylitis, enthesitis, and fibromyalgia were observed, respectively, in 17.6, 51.2, and 5.7% of patients with axial SpA and 24.3, 40, and 3.1% of patients with peripheral SpA. In both disease groups, women tended to report depression, joint tenderness, and higher disease activity more frequently than their male counterparts. At inclusion, a new diagnosis of SpA was performed in 58% of axial and 77% of peripheral patients, with a median time from symptom onset to diagnosis of 36 and 24 months, respectively. At baseline, most patients with axial SpA (77%) started a biological DMARD, while over half of the peripheral patients started a conventional DMARD.Conclusions: Based on a well-characterized clinical registry of SpA, we provided real-world insights on the clinical features of DMARD-naïve SpA patients, pointing out major differences between axial and peripheral disease in terms of clinical characteristics and treatment pattern. Future prospective evaluations within the SIRENA study will improve knowledge on SpA and contribute to defining the best therapeutic approach.

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Registries in Spondyloarthritis: What have we Learned?

Cited by 2 publications

References 8 publications

Persistence, effectiveness and safety of ustekinumab compared to TNF inhibitors in psoriatic arthritis within the Italian PsABio cohort

Persistence, effectiveness and safety of ustekinumab compared to TNF inhibitors in psoriatic arthritis within the Italian PsABio cohort

An Italian Disease-Based Registry of Axial and Peripheral Spondyloarthritis: The SIRENA Study

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