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Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade^® to Remsima^®? An Observational Study.

ABSTRACT: Background: Since the late '90s, infliximab (Remicade^®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima^® were introduced in clinical practice. Aim: To investigate the interchangeability of Remicade^® (originator infliximab) and its biosimilar Remsima^® in patients with rare immune-mediated inflammatory diseases (IMIDs). Methods: This two-phased prospective open label observational study was designed to monitor the transition from Remicade^® to Remsima^® in patients with rare IMIDs. All included patients were followed during the first 2 years. The primary endpoint was the demonstration of non-difference in quality of life and therapeutic efficacy, as measured by parameters including a safety monitoring program, physicians perception of disease activity (PPDA) and patient self-reported outcomes (PSROs). Secondary outcomes included routine blood analysis, pre-infusion serum drug concentration values and anti-drug antibody formation. Results: Forty eight patients treated with Remicade^® were switched to Remsima^® in June-July 2016 and subsequently monitored during the first 2 years. The group consisted of patients with sarcoidosis (n = 17), Behçet's disease (n = 12), non-infectious uveitis (n = 11), and other diagnoses (n = 8). There were no significant differences in PPDA, PSROs, clinical and laboratory assessments and pre-infusion serum drug concentrations between the groups. De novo anti-drug antibodies were observed in two patients. Seven patients with sarcoidosis and five with another diagnosis developed a significant disease relapse (n = 7) or adverse events (n = 5) within 2 years; 10 of these patients discontinued Remsima^® treatment, one withdrew from the study and one received additional corticosteroid therapy. Conclusions: We observed no significant differences in PSROs, PPDA and laboratory parameters after treatment was switched from Remicade^® to Remsima^®. However, disease relapse or serious events were observed in 12 out of 48 patients when treatment was switched from Remicade^® to Remsima^®. The choice to switch anti-TNF alpha biologics in patients with rare IMIDs, particularly in sarcoidosis, requires well-considered decision-making and accurate monitoring due to a possibly higher incidence of disease worsening.

SUBMITTER: Xue L

PROVIDER: S-EPMC7424016 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study.

Xue Laixi L van Bilsen K K Schreurs M W J MWJ van Velthoven M E J MEJ Missotten T O TO Thiadens A A H J AAHJ Kuijpers R W A M RWAM van Biezen P P Dalm V A S H VASH van Laar J A M JAM Hermans M A W MAW Dik W A WA van Daele P L A PLA van Hagen P M PM

Frontiers in medicine 20200806

Background: Since the late '90s, infliximab (Remicade®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima® were introduced in clinical practice. Aim: To investigate the interchangeability of Remicade® (originator infliximab) and its biosimilar Remsima® in patients with rare immune-mediated inflammatory diseases ...[more]

PMID: 32850911

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Project description:BackgroundAutoimmune disorders have primary manifestations such as joint pain and bowel inflammation but can also have secondary manifestations such as non-infectious uveitis (NIU). A regulatory health authority raised concerns after receiving spontaneous reports for NIU following exposure to Remicade®, a biologic therapy with multiple indications for which alternative therapies are available. In assessment of this clinical question, we applied validity diagnostics to support observational data causal inferences.MethodsWe assessed the risk of NIU among patients exposed to Remicade® compared to alternative biologics. Five databases, four study populations, and four analysis methodologies were used to estimate 80 potential treatment effects, with 20 pre-specified as primary. The study populations included inflammatory bowel conditions Crohn's disease or ulcerative colitis (IBD), ankylosing spondylitis (AS), psoriatic conditions plaque psoriasis or psoriatic arthritis (PsO/PsA), and rheumatoid arthritis (RA). We conducted four analysis strategies intended to address limitations of causal estimation using observational data and applied four diagnostics with pre-specified quantitative rules to evaluate threats to validity from observed and unobserved confounding. We also qualitatively assessed post-propensity score matching representativeness, and bias susceptibility from outcome misclassification. We fit Cox proportional-hazards models, conditioned on propensity score-matched sets, to estimate the on-treatment risk of NIU among Remicade® initiators versus alternatives. Estimates from analyses that passed four validity tests were assessed.ResultsOf the 80 total analyses and the 20 analyses pre-specified as primary, 24% and 20% passed diagnostics, respectively. Among patients with IBD, we observed no evidence of increased risk for NIU relative to other similarly indicated biologics (pooled hazard ratio [HR] 0.75, 95% confidence interval [CI] 0.38-1.40). For patients with RA, we observed no increased risk relative to similarly indicated biologics, although results were imprecise (HR: 1.23, 95% CI 0.14-10.47).ConclusionsWe applied validity diagnostics on a heterogenous, observational setting to answer a specific research question. The results indicated that safety effect estimates from many analyses would be inappropriate to interpret as causal, given the data available and methods employed. Validity diagnostics should always be used to determine if the design and analysis are of sufficient quality to support causal inferences. The clinical implications of our findings on IBD suggests that, if an increased risk exists, it is unlikely to be greater than 40% given the 1.40 upper bound of the pooled HR confidence interval.

Project description:Pruritus is a common clinical sign in dogs and is often underrecognized by dog owners and veterinarians. The Whistle FIT®, a wearable accelerometer paired with analytics, can detect changes in pruritic activity in dogs, which can be reported to owners in a smartphone/tablet application. The objectives of this retrospective observational study were to investigate the impact of digital alerts for increased pruritic behaviors received by dog owners in a real-life setting, on (1) the initiation of veterinary clinic visits, and (2) if such visits resulted in initiation of therapy for pruritus. Whistle FIT® data and electronic health records from 1,042 Banfield veterinary clinics in the United States were obtained for a 20-month period and reviewed retrospectively. Data on times of increased pruritic behaviors was calculated retrospectively by the investigators by applying the same algorithms used in the Whistle system. Data from the first 10-month interval was compared to the second 10 months, when reports on pruritic behaviors and alerts for increased pruritic behaviors were viewable by pet owners. Signalment of dogs with clinic visits in the first (n = 7,191) and second (n = 6,684) 10-month groups was similar. The total number of pruritic alerts was 113,530 in the first 10 months and 93,217 in the second 10 months. The odds of an 'alert visit' (the first veterinary clinic visit that occurred within 4 weeks after the time of a pruritus alert) was statistically significantly more likely (odds ratio, 1.6264; 95% CI, 1.57-1.69; p < 0.0001) in the second 10-month period compared to the first 10-month period. The total number of medications administered was 10,829 in the first 10 months and 9,863 in the second 10 months. The percentage of medications prescribed within 4 weeks after a pruritus alert was higher in the second 10 month period (53.3%) compared to the first 10 month period (38.8%). This study suggests that pruritus alerts sent to dog owners may improve owner recognition of pruritic behaviors and increase the likelihood of a veterinary visit to treat canine pruritus.

Project description:INTRODUCTION:In real-life practice, asthma remains poorly controlled, with a considerable burden on patients' quality of life. Budesonide/formoterol (B/F) Easyhaler® has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler®, but no real-life comparisons are yet available in patients switching from B/F Turbuhaler® to B/F Easyhaler®. METHODS:The primary objective of this real-life, non-interventional, observational study was to show non-inferiority of asthma control when adult patients in Swedish primary care with persistent asthma switched from B/F Turbuhaler® to B/F Easyhaler®. At visit 1, baseline demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler®. The study comprised a control visit (visit 2) and a concluding examination (visit 3) after 12 weeks. Asthma control was assessed using the Asthma Control Test (ACT). The mini-Asthma Quality of Life Questionnaire (AQLQ) and lung function test were performed, and participants and investigators answered questionnaires about ease-of-use and teaching. RESULTS:A total of 117 patients were enrolled in the on-treatment population; 81 (64.8%) were female. At visit 3, B/F Easyhaler® demonstrated non-inferiority to B/F Turbuhaler®; the mean difference in change from baseline ACT was statistically significant (18.9 vs. 20.7, respectively; p < 0.0001) and met the non-inferiority criteria of B/F Easyhaler® being greater than - 1.5 points versus the reference product. Asthma was well controlled in 62 (53.0%) patients at baseline, increasing to 83 patients (70.9%) at visit 3. Patients experienced statistically significant improvements in mini-AQLQ score after B/F Easyhaler® treatment and lung function remained stable across the treatment period. B/F Easyhaler® was easy to learn and prepare for use. CONCLUSION:This real-life, non-interventional, non-inferiority study in adults with persist asthma demonstrates equivalent or better disease control when patients switch from B/F Turbuhaler® to B/F Easyhaler®. A further study with direct comparison between treatments could add to the understanding of inhaler switch. FUNDING:Orion Corporation, Orion Pharma.

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Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade^® to Remsima^®? An Observational Study.

Publications

Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade<sup>®</sup> to Remsima<sup>®</sup>? An Observational Study.

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