Real-world observational study of biosimilars in inflammatory arthritis treatment: a systematic literature review

Kim, Ji-Won; Jung, Ju‐Yang; Suh, Chang‐Hee

doi:10.1080/14712598.2020.1812575

Cited by 11 publications

(10 citation statements)

References 69 publications

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“…We found two systematic reviews supporting the use of biosimilars but both are of low quality. 26 27 As mentioned in the introduction, the expert group of Kay et al has formulated consensus-based recommendations for biosimilar use in clinical care. 9 The current point to consider is directly adapted from one of their overarching principles, which states that approved biosimilars in highly regulated areas are neither better nor worse in efficacy and non-inferior in safety to bio-originators.…”

Section: Resultsmentioning

confidence: 99%

Points to consider for cost-effective use of biological and targeted synthetic DMARDs in inflammatory rheumatic diseases: results from an umbrella review and international Delphi study

et al. 2023

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ObjectivesTo develop evidence-based points to consider for cost-effective use of biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the treatment of inflammatory rheumatic diseases, specifically rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis.MethodsFollowing EULAR procedures, an international task force was formed, consisting of 13 experts in rheumatology, epidemiology and pharmacology from seven European countries. Twelve strategies for cost-effective use of b/tsDMARDs were identified through individual and group discussion. For each strategy, PubMed and Embase were systematically searched for relevant English-language systematic reviews and, for six strategies, additionally for randomised controlled trials (RCTs). Thirty systematic reviews and 21 RCTs were included. Based on the evidence, a set of overarching principles and points to consider was formulated by the task force using a Delphi procedure. Level of evidence (1a–5) and grade (A–D) were determined for each point to consider. Individual voting on the level of agreement (LoA; between 0 (completely disagree) and 10 (completely agree)) was performed anonymously.ResultsThe task force agreed on five overarching principles. For 10 of 12 strategies, the evidence was sufficient to formulate one or more points to consider, leading to 20 in total, regarding response prediction, drug formulary use, biosimilars, loading doses, low-dose initial therapy, concomitant conventional synthetic DMARD use, route of administration, medication adherence, disease activity–guided dose optimisation and non-medical drug switching. Ten points to consider (50%) were supported by level 1 or 2 evidence. The mean LoA (SD) varied between 7.9 (1.2) and 9.8 (0.4).ConclusionThese points to consider can be used in rheumatology practices and complement inflammatory rheumatic disease treatment guidelines to incorporate cost-effectiveness in b/tsDMARD treatment.

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Section: Resultsmentioning

confidence: 99%

Points to consider for cost-effective use of biological and targeted synthetic DMARDs in inflammatory rheumatic diseases: results from an umbrella review and international Delphi study

et al. 2023

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“…A recent systematic review about the biosimilars of adalimumab showed comparable efficacy, safety and immunogenicity among the different types of BIOs compared with the reference drug [48]. Moreover, another review that highlights the real-world data of biosimilars in adult patients with arthritis showed no significant inferiority in treatment outcomes, resulting in considerable cost savings [49].…”

Section: Discussionmentioning

confidence: 99%

OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis

et al. 2021

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Objectives Limited data about use of biosimilars are available in children with Juvenile Idiopathic Arthritis (JIA). This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars, in children with JIA, in a real-world setting. Methods This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar. Results 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA), and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced AE. Conclusion Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs also in paediatric patients with JIA.

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“…The available literature on switching in patients with IBDs was categorized as "weak evidence" using the GRADE approach for rating the certainty of evidence [18,19] and there have been calls for direct evidence of clinical benefits and harms based on interventional studies, postmarketing observational research, and surveillance of policies on nonmedical switching [16,17,18]. Recent interventional and observational studies and systematic literature reviews found similar benefits and harms related to the biosimilar infliximab compared with the originator in adult [20][21][22][23][24][25][26][27][28][29]30] and pediatric patients [31] with IBD. However, data on the impact of policies for a nonmedical switch are lacking [9,[32][33][34], and in patients with IBDs, the surveillance to date has been limited to switching rates [32].…”

Section: Introductionmentioning

confidence: 99%

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study

Fisher

Kim

Dormuth

2023

Gastroenterology Research and Practice

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Background. On September 5, 2019, British Columbia announced a new policy (the Biosimilars Initiative) to switch from originator to biosimilar infliximab for patients with inflammatory bowel diseases. Objective. To monitor the impacts of the policy on the use of medications and health services during the first year of the policy. Methods. In this population-based cohort study, we used administrative health data to construct three historical cohorts and one policy cohort of patients with inflammatory bowel diseases who used the originator infliximab. We then monitored the cumulative incidence of medications and health services. Log-likelihood ratios were used to quantify differences between the policy cohort and the average of the historical cohorts. Results. The cohorts included 1839–2368 users of the originator infliximab, ages 4–90 years, mean age 43 years. During the first year of follow-up, we found: (1) a 0.9% increase in the first dispensation of infliximab, biosimilar, or originator; (2) a 16.2% increase in infliximab dose escalation; (3) a decrease of 2.4% in the dispensation of antibiotics and a 2.6% decrease in new use of prednison; (4) an anticipated increase in visits to physicians and gastroenterologists to manage switching to biosimilars (24.0%); (5) a 4.0% decrease in discharges from hospital; and (6) a 2.9% decrease in emergency admissions to hospital. Conclusion. British Columbia’s Biosimilars Initiative for nonmedical switching from originator to biosimilar infliximab for inflammatory bowel diseases was not associated with harmful impacts on medications and health services use. An increase in dose escalation was accompanied by an improvement in health status proxies.

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Real-world observational study of biosimilars in inflammatory arthritis treatment: a systematic literature review

Cited by 11 publications

References 69 publications

Points to consider for cost-effective use of biological and targeted synthetic DMARDs in inflammatory rheumatic diseases: results from an umbrella review and international Delphi study

Points to consider for cost-effective use of biological and targeted synthetic DMARDs in inflammatory rheumatic diseases: results from an umbrella review and international Delphi study

OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study

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