The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy

Armuzzi, Alessandro; Fiorino, Gionata; Variola, Angela; Manetti, Natalia; Fries, Walter; Orlando, Ambrogio; Maconi, Giovanni; Bossa, Fabrizio; Cappello, Maria; Biancone, Livia; Cantoro, Laura; Costa, Francesco; D’Incà, R.; Lionetti, Paolo; Principi, Mariabeatrice; Castiglione, Fabiana; Annunziata, Maria Laura; Sabatino, Antonio Di; Girolamo, Maria Di; Terpin, M.; Cortelezzi, C.C.; Saibeni, Simone; Amato, Arnaldo; Ardizzone, Sandro; Guidi, Luisa; Danese, Silvio; Massella, Arianna; Ventra, Agostino; Rizzuto, G.; Massari, A.; Perri, Francesco; Annese, Vito; Saettone, Silvia; Tari, Roberto; Petruzzellis, C.; Meucci, Gianmichele; Imperiali, G.; Guglielmi, Francesco William; Mazzuoli, S.; Caserta, L.; Parodi, M.C.; Colli, Agostino; Ronchetti, Anna; Pugliese, Daniela; Geccherle, Andrea; Rogai, Francesca; Milani, Stefano; Renna, Sara; Cassinotti, A.; Andriulli, Angelo; Martino, Giuseppina; Scrivo, Barbara; Troncone, Edoardo; Kohn, Anna; Bertani, Lorenzo; Lorenzon, Greta; Ghione, S; Nardone, Olga Maria; Vecchi, Maurizio; Bertani, A.; Bosani, M.; Bezzio, Cristina; Salerno, Raffaele

doi:10.1093/ibd/izy264

Cited by 56 publications

(56 citation statements)

References 39 publications

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“…The results showed non-inferiority of CT-P13 in comparison with the reference drug in the overall study population (n = 482), although the analysis of each disease sub-group is not reliable due to underpower. Such reassuring findings have been confirmed in a large prospective cohort of IBD patients treated with CT-P13: in particular, among all subjects included in this study (n = 810), 155 were switched from infliximab originator to the biosimilar, with no increase of adverse events and without affecting persistence of therapy [6]. The SECURE trial [7] analyzed as primary endpoint the serum drug level of CT-P13 16 weeks after switching from the originator in patients with IBD in clinical remission: results showed no differences in the pharmacokinetics and confirmed comparable outcomes in terms of efficacy and safety.…”

Section: Infliximab Biosimilars In Ibd: the Evidencesupporting

confidence: 66%

The role of healthcare providers in accompanying biosimilars in inflammatory bowel diseases

Felice

Pugliese

Armuzzi

2019

Expert Opinion on Biological Therapy

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Section: Infliximab Biosimilars In Ibd: the Evidencesupporting

confidence: 66%

The role of healthcare providers in accompanying biosimilars in inflammatory bowel diseases

Felice

Pugliese

Armuzzi

2019

Expert Opinion on Biological Therapy

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“…Nevertheless, our finding is not unique: a recent study of gastroenterologists in the United States found that half of 500 interviewees considered the risk of side effects a barrier in prescribing biologics to UC patients. 27 As new biological drugs with different mechanisms of action and likely better safety profiles (eg vedolizumab and ustekinumab) become available, and as Italian physicians gain experience with biologic therapies, including biosimilars, 28 we can expect that the prescription of these drugs in Italy will become more confident and widespread.…”

Section: Discussionmentioning

confidence: 99%

Barriers to anti‐TNFalpha prescription among Italian physicians managing inflammatory bowel disease

Bezzio¹,

Imperatore

Armuzzi

et al. 2019

GastroHep

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Summary Background Italian physicians managing IBD patients seem to prescribe anti‐TNFalpha agents less frequently than physicians in other countries. Aims To investigate reasons and situations that limit the use of these medications. Methods A questionnaire was distributed to 600 physicians attending IG‐IBD events. Results Two hundred eighty physicians (46.7%) completed the questionnaire. Most physicians (76.2%) prescribed anti‐TNFalpha every time one was needed, however, 12.6% were limited by budget, 8.1% lacked confidence, 2.2% lacked permission and 0.9% chose not to prescribe them. The limitations in using anti‐TNFalpha were: fear of side effects (39.1%), costs (38.2%), administrative/bureaucratic limitations (8.0%) and lack of staff (6.2%). The main feared side effects include: opportunistic infection (45.7%), neoplasms (25.4%), allergic reactions (12.5%), reactivation of tuberculosis (7.3%) and onset of autoimmune disease (7.3%). Physicians younger than 45 years of age and with less than 15 years of clinical experience were more likely to prescribe anti‐TNFalpha than older physicians (70.8% vs 57.1%; P = 0.022) than more experienced physicians (71.2% vs 58.9%; P = 0.033). Conclusions The apparent underuse of anti‐TNFalpha in Italy can be attributed mainly to physicians’ fears of side effects, concerns about costs and scarce familiarity with these drugs. Addressing these barriers may lead to an improvement in the quality of assistance to IBD patients.

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“…The evidence base in IBD has grown substantially in the intervening years. Indeed, a recent randomised phase 3 trial definitively showed the non-inferiority of a biosimilar infliximab to the originator product in IBD [38] , and this has been supported by data from multiple 'real-world' studies [39][40][41][42].…”

Section: Anti-tnf Biosimilars In Ibd Management: Growing Confidence Amentioning

confidence: 92%

Enhancing treatment success in inflammatory bowel disease: Optimising the use of anti-TNF agents and utilising their biosimilars in clinical practice

Armuzzi

Bouhnik

Cummings

et al. 2020

Digestive and Liver Disease

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Anti-tumour necrosis factor (TNF) agents such as infliximab and adalimumab have greatly altered the treatment landscape in inflammatory bowel disease (IBD). However, there are remaining unmet needs and opportunities to optimise their use. Recent data suggest that proactive therapeutic drug monitoring may lead to more efficient usage of these agents, with potential for higher rates of corticosteroid-free clinical remission than with reactive monitoring. Expanded application of faecal calprotectin measurements may also be valuable, given the ease of use of the assay and its proven effectiveness as a diagnostic tool and predictor of relapse risk. From a practical viewpoint, improved multidisciplinary working may be essential to optimise patient care, with IBD nurse specialists playing an increasingly central role within this model. Finally, the availability of biosimilars of the anti-TNF agents allow drug costs to be reduced without compromising safety or efficacy-thereby providing opportunities to improve accessibility. Alongside extensive data on originator to biosimilar infliximab switch, new studies are beginning to demonstrate the safety of biosimilar to biosimilar switch, as well as adalimumab biosimilar transitions. The risk of a nocebo effect when switching to a biosimilar can be reduced through improved patient education and preparation.

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The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy

Abstract: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

Cited by 56 publications

References 39 publications

The role of healthcare providers in accompanying biosimilars in inflammatory bowel diseases

The role of healthcare providers in accompanying biosimilars in inflammatory bowel diseases

Barriers to anti‐TNFalpha prescription among Italian physicians managing inflammatory bowel disease

Enhancing treatment success in inflammatory bowel disease: Optimising the use of anti-TNF agents and utilising their biosimilars in clinical practice

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