The PROSIT-BIO Cohort

Fiorino, Gionata; Manetti, Natalia; Armuzzi, Alessandro; Orlando, Ambrogio; Variola, Angela; Bonovas, Stefanos; Bossa, Fabrizio; Maconi, Giovanni; D’Incà, R.; Lionetti, Paolo; Cantoro, Laura; Fries, Walter; Annunziata, Maria Laura; Costa, Francesco; Terpin, M.; Biancone, Livia; Cortelezzi, C.C.; Amato, Arnaldo; Ardizzone, Sandro; Danese, Silvio; Guidi, L.; Rizzuto, G.; Massella, Arianna; Andriulli, Angelo; Massari, A.; Lorenzon, Greta; Ghione, S; Kohn, Anna; Ventra, Agostino; Annese, Vito; Cohort, Prosit-Bio

doi:10.1097/mib.0000000000000995

Cited by 121 publications

(40 citation statements)

References 36 publications

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“…improvement) in duration of morning stiffness [median duration, from 7.2 to 5.8 (no units provided); P = 0.02] in patients with arthritis switching from originator to biosimilar infliximab [47]. In the three remaining studies that included statistical analyses, IBD disease activity significantly improved in paediatric patients switched from originator to biosimilar infliximab ( P < 0.05; actual values not reported) [66], but significantly worsened in adults who underwent a similar switch (median IBD-Control-8 score, from 11 to 14; P < 0.05) [63], and primary failure was significantly lower in patients with IBD switched from originator to biosimilar infliximab than in patients switched from other biologics or who were treatment naïve (0 vs 11 and 10%, respectively; P < 0.05) [50]. …”

Section: Resultsmentioning

confidence: 99%

“…In terms of safety data after switching, eight studies reported no concerns or similar safety profiles before and after switching [43, 44, 47, 50, 62, 63, 79, 87, 89], six studies reported no general safety data [45, 51, 72, 77, 83, 90], and 12 studies reported adverse events such as injection site pain, acute hypersensitivity reactions, rash and infusion reactions after switching (although most did not provide comparative data from before switching) [46, 48, 49, 52, 54, 58, 65–68, 71, 88]. …”

Section: Resultsmentioning

confidence: 99%

“…No significant change in CRP, Hb, FC, INX dose, dose interval or plasma INX levels post-switch. All P NSPost-switch: AEs in 17 patients (3 with UC, 14 with CD); 5 infusion reactions (leading to treatment discontinuation in 1 patient)Baseline vs new post-switch: n = 2 vs n = 3 patientsDapavo et al 2016 [49]With plaque psoriasis ( N = 35)30INX RP, median duration 237 weeksCT-P13, median follow-up 23 weeks with median 4 cyclesPre- vs post-switch (end of follow-up), PASI score: P NS (actual values NR); VAS scores: P NS (actual values NR)Post-switch: herpes zoster (1 patient)NRFiorino et al 2017 [50]With IBD ( N = 547)97INX RP, duration NR; mean number of infusions 18 [study also included patients with no treatment (naive) or other biologic pre-switch]CT-P13 switch group, median follow-up 6.6 monthsINX RP/CT-P13 vs naive/CT-P13 vs other/CT-P13, estimated probability of response at 24 weeks: 79 vs 74 vs 63%. Primary failure: 0 vs 10 vs 11% ( P = 0.005).…”

Section: Introductionmentioning

confidence: 99%

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Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

et al. 2018

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Background The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern.Objectives The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps.Methods A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies.ResultsThe systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups.Conclusions There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.Electronic supplementary materialThe online version of this article (10.1007/s40259-017-0256-z) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

et al. 2018

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“…Recently, the clinical outcome of 547 IBD consecutive patients (313 CD and 234 UC) enrolled from 31 referral centers has been reported; 311 patients were naive to anti-TNFα agents, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18±14 infusions of IFX 60. The mean follow-up was 4.3±2.8 months, and the total follow-up time was 195 patient-years.…”

Section: Ct-p13: Post-marketing Experience In Ibdmentioning

confidence: 99%

“…This study has several limitations such as the small sample size, the heterogeneity of time of switching during therapy, and the great variation in length of the individual follow-up period, but it demonstrates that switching from IFX to CT-P13 seems to be well tolerated in children with CD (Table 2). 60,63–65…”

Section: Switching and Alternation Of Biosimilarsmentioning

confidence: 99%

CT-P13: design, development, and place in therapy

Gabbani

Deiana

Annese³

2017

DDDT

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The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016. The Phase I and Phase III clinical trials conducted in ankylosing spondylitis and rheumatoid arthritis have demonstrated pharmacokinetic and efficacy equivalence with comparable safety and immunogenicity to IFX. For these reasons, the use of CT-P13 has been extrapolated also to inflammatory bowel disease. There have been some initial concerns regarding the use of CT-P13 in inflammatory bowel disease patients, because of the lack of randomized controlled trials. However, emerging real-world data have further confirmed the comparability between CT-P13 and its reference product in terms of efficacy, safety, and immunogenicity, in patients naïve to the anti-tumor necrosis factor alpha agents and after switching from IFX, and will be summarized in this review.

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