FRI0107 Romanian Registry of Rheumatic Diseases: Efficacy and Safety of Biologic Therapy in Rheumatoid Arthritis

Codreanu, Cătălin; Mogoşan, Corina; Enache, Luminița; Stanciu, Daniela; Ionescu, R.; Opriş, D.; Rednic, Simona; Parvu, M.

doi:10.1136/annrheumdis-2015-eular.5823

Cited by 3 publications

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“…S2). The modified Downs and Black instrument was used to assess the quality of the 22 identified abstracts for original studies [39, 63–83], with scores of fair quality (3–4) for four studies [39, 66, 70, 76], good quality (5–8) for seven studies [63, 65, 67, 68, 73, 77, 79], and excellent quality (9–12) for 11 studies [64, 69, 71, 72, 74, 75, 78, 80–83] (ESM Fig. S3).…”

Section: Resultsmentioning

confidence: 99%

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

et al. 2016

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BackgroundDespite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it.ObjectivesThe objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence.MethodsMEDLINE, Embase, and ISI Web of Science were searched to September 2015. Conference proceedings (n = 17) were searched 2012 to July 2015. Included studies were categorized by originator, study type, and indication. To assess data strength and validity, risk of bias assessments were undertaken.ResultsAcross therapeutic areas, 43 named (marketed or proposed) biosimilars were identified for adalimumab, abciximab, bevacizumab, etanercept, infliximab, omalizumab, ranibizumab, rituximab, and trastuzumab originators. Infliximab CT-P13, SB2, and etanercept SB4 biosimilars have the greatest amount of published evidence of similarity with their originators, based on results of clinical studies involving larger numbers of patients or healthy subjects (N = 1405, 743, and 734, respectively). Published data were also retrieved for marketed intended copies of etanercept and rituximab.ConclusionsThis unbiased synthesis of the literature exposed significant differences in the extent of published evidence between molecules at preclinical, clinical, and post-marketing stages of development, providing clinicians and payers with a consolidated view of the available data and remaining gaps.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-016-0199-9) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

et al. 2016

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“…An observational cross-sectional study, which included RA patients from Romania who were treated with biologic agents, assessed efficacy and safety data after 2 years of treatment with infliximab, CT-P13, etanercept, adalimumab, or rituximab [122]. …”

Section: Resultsmentioning

confidence: 99%

“…For this reason, the Downs and Black instrument was adapted to assess the quality of the 22 identified abstracts for additional original studies (Tables 1, 2, 3, 4, 5, 6, ESM Fig. S5) [26, 41, 47, 48, 98, 63, 46, 119, 122, 103, 81, 74, 79, 82, 124, 125, 126, 130, 128, 104, 50, 34]. The average score for the abstract publications was 7.8 out of a possible 12 points.…”

Section: Resultsmentioning

confidence: 99%

“…The average score for the abstract publications was 7.8 out of a possible 12 points. The total score was fair quality (3–4) for four studies [81, 74, 125, 130], good quality (5–8) for seven studies [48, 122, 79, 82, 126, 128, 104], and excellent quality (9–12) for 11 studies [26, 41, 47, 98, 63, 45, 119, 103, 124, 50, 34]. The majority of the studies published as conference abstracts were of good or excellent quality (81.8%).…”

Section: Resultsmentioning

confidence: 99%

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Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence

et al. 2016

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BackgroundClinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications.ObjectivesThe objective of this study was to systematically collate all published data in order to assess the weight (quantity and quality) of available evidence for each molecule and inform and support healthcare decision-making in chronic inflammatory diseases.MethodsMEDLINE®, EMBASE®, and ISI Web of Science® were searched to September 2015. Selected conference proceedings were searched from 2012 to July 2015. Studies disclosing biosimilars with unique identifiers were categorized by originator, study type, and indication. Risk of bias assessments were performed. Intended copies were differentiated as commercially available agents without evidence of rigorous comparative biosimilarity evaluations.ResultsProposed biosimilars for adalimumab, etanercept, infliximab, and rituximab are reported in the published literature. Across indications, approved biosimilars infliximab CT-P13, SB2, and etanercept SB4 have published studies involving the largest number of patients or healthy subjects (n = 1405, 743, and 734, respectively), mostly in rheumatoid arthritis. At data cut-off, only CT-P13 had published data in ankylosing spondylitis (n = 250; randomized control trial) and ulcerative colitis/Crohn’s disease (n = 336; observational studies). Published data were not available for ongoing studies in psoriasis patients. Four intended copies were identified in published studies (total: n = 1430; n = 1372 in observational studies). Thematic analysis of non-empirical publications showed that indication extrapolation remains an issue, particularly for gastroenterologists.ConclusionsWhile most agents display a moderate to high degree of similarity to their originator in the published studies identified, large discrepancies persist in the overall amount and type of data available in the public domain. Significant gaps exist particularly for intended copies, reinforcing the need to maintain a clear differentiation between these molecules and true biosimilars.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-016-0201-6) contains supplementary material, which is available to authorized users.

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Commonalities and differences in set-up and data collection across European spondyloarthritis registries — results from the EuroSpA collaboration

Linde,

Ørnbjerg,

Rasmussen

et al. 2023

Arthritis Res Ther

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Background In European axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) clinical registries, we aimed to investigate commonalities and differences in (1) set-up, clinical data collection; (2) data availability and completeness; and (3) wording, recall period, and scale used for selected patient-reported outcome measures (PROMs). Methods Data was obtained as part of the EuroSpA Research Collaboration Network and consisted of (1) an online survey and follow-up interview, (2) upload of real-world data, and (3) selected PROMs included in the online survey. Results Fifteen registries participated, contributing 33,948 patients (axSpA: 21,330 (63%), PsA: 12,618 (37%)). The reported coverage of eligible patients ranged from 0.5 to 100%. Information on age, sex, biological/targeted synthetic disease-modifying anti-rheumatic drug treatment, disease duration, and C-reactive protein was available in all registries with data completeness between 85% and 100%. All PROMs (Bath Ankylosing Spondylitis Disease Activity and Functional Indices, Health Assessment Questionnaire, and patient global, pain and fatigue assessments) were more complete after 2015 (68–86%) compared to prior (50–79%). Patient global, pain and fatigue assessments showed heterogeneity between registries in terms of wording, recall periods, and scale. Conclusion Important heterogeneity in registry design and data collection across fifteen European axSpA and PsA registries was observed. Several core measures were widely available, and an increase in data completeness of PROMs in recent years was identified. This study might serve as a basis for examining how differences in data collection across registries may impact the results of collaborative research in the future.

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FRI0107 Romanian Registry of Rheumatic Diseases: Efficacy and Safety of Biologic Therapy in Rheumatoid Arthritis

Cited by 3 publications

References 0 publications

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence

Commonalities and differences in set-up and data collection across European spondyloarthritis registries — results from the EuroSpA collaboration

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