Antigenic response to <scp>CT</scp>‐P13 and infliximab originator in inflammatory bowel disease patients shows similar epitope recognition

Gonçalves, João; Santos, Margarida; Acúrcio, Rita C.; Iria, Inês; Gouveia, Luís F.; Brito, Paula M.; Cunha-Santos, Catarina; Barbas, Ana; Galvão, Joana; Barbosa, I.; Aires-da-Silva, Frederico; Alcobia, A; Cavaco, Marco; Cardoso, Miguel; Alves, José Delgado; Carey, John J.; Dörner, Thomas; Fonseca, João Eurico; Palmela, Carolina; Torres, Joana; Vieira, Catarina; Trabuco, D.; Fiorino, Gionata; Strik, Anne S.; Yavzori, Miri; Rosa, Isadora; Correia, Luís; Magro, Fernando; D’Haens, Geert R.; Ben‐Horin, Shomron; Lakatos, László; Danese, Silvio

doi:10.1111/apt.14808

Cited by 21 publications

(16 citation statements)

References 34 publications

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“…22 Other studies have also shown similar cross-immunogenicity results between INF, CT-P13, and SB2, 12,13,16,23 and similar functional inhibition of TNF-α binding. 12,16 The NOR-SWITCH study and its open-label extension showed that switching from INF to CT-P13 was not inferior to continued treatment with INF, and immunogenicity was not different between the two treatments. 24,25 Although the NOR-SWITCH study enrolled a large number of patients with varying diagnoses, the number of patients with IBD was relatively small in the main trial (Crohn disease, n = 155; ulcerative colitis, n = 93), which limits the ability to generalize to a larger population.…”

Section: Discussionmentioning

confidence: 61%

SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis

Gonçalves

Myung

Park

et al. 2019

Therap Adv Gastroenterol

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Background: The primary objective of this study was to analyze the cross-reactivity of antidrug antibodies to reference adalimumab (ADL) and SB5 (adalimumab biosimilar) in patients with inflammatory bowel disease (IBD) or rheumatoid arthritis (RA). Methods: Sera from patients with IBD and RA with or without antibodies to adalimumab (ATA+ or ATA–, respectively) were tested for cross-reactivity with SB5 and ADL. Functional inhibition of tumor necrosis factor-α binding was measured. Sera from patients with antibodies to reference infliximab (ATI+) were examined for cross-reactivity to SB5. Sera were tested by enzyme-linked immunosorbent assay. Results: All 30 anti-ADL ATA+ sera from patients with IBD and all 4 anti-SB5 ATA+ sera from patients with RA were cross-reactive with ADL and SB5 (range of mean concentrations: IBD, 20.99–21.31 μg/ml; RA, 16.46–17.48 μg/ml). In general, there was no significant difference between mean ATA titers. A strong correlation was detected in all ATA+ samples (rho = 0.997 to >0.999; p < 0.001 each). However, ATA– sera were not reactive to either ADL or SB5. anti-ADL ATA+ sera similarly neutralized functional activity of ADL and SB5; no functional inhibition was observed with ATA– sera. ATI+ sera did not cross-react with SB5. Conclusions: ADL and SB5 show cross-immunogenicity in sera from patients with IBD or RA, supporting shared immune-dominant epitopes. ATI+ sera did not cross-react with SB5, suggesting different immunogenic epitopes between infliximab and SB5.

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Section: Discussionmentioning

confidence: 61%

SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis

Gonçalves

Myung

Park

et al. 2019

Therap Adv Gastroenterol

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“…However, this increase was also associated with an increase in the reports of AE induced by IFX biosimilars [33]. This seems to contrast with a recent study by Gonçalves et al , who found a similar antigenic profile for IFX originator and IFX biosimilar CT-P13 [34]. Finally, the recent PROSIT Italian cohort study found a 19% rate of AE [23].…”

Section: Discussionmentioning

confidence: 93%

Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

Tursi

Mocci

Faggiani

et al. 2019

aog

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Background The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers. Methods Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn’s disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety. Results One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. Conclusion This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator.

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“…Thus, the clinical immunogenicity of biosimilars can be assessed relatively reliably (38). For example, results from a study comparing specific antigenic epitopes between CT-P13 and infliximab reference product have recently been reported, and suggest the two drugs have similar epitope binding profiles and equivalent immunogenicity (39).…”

Section: Demonstrating Anti-tnf Biosimilaritymentioning

confidence: 99%

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Barker

Girolomoni

Egeberg

et al. 2019

Journal of Dermatological Treatment

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Tumor necrosis factor (TNF) inhibitors account for a large proportion of drugs used to treat psoriasis and are indicated first-line options in certain settings. Several biosimilar drugs based on the anti-TNF agents adalimumab, infliximab, and etanercept are now available for use in patients with psoriasis. The favorable cost differential of biosimilars is expected to improve access to biologic therapy for biologic-naive psoriasis patients, who are often undertreated. Also, substantial cost savings can be made if patients are switched to biosimilars. To date, most clinical testing of anti-TNF biosimilars approved for use in psoriasis has been performed in patients with rheumatoid arthritis, and the results extrapolated to psoriasis. Although this may initially raise concerns for clinicians looking to start their psoriasis patients on biologic treatment with a biosimilar or switch from an original biologic to a biosimilar, the process of extrapolation is tightly regulated and scientifically justified. Furthermore, available real-world evidence of the safety and efficacy of anti-TNF agents in patients with psoriasis complements clinical trial data in patients with rheumatoid arthritis. When equipped with the appropriate knowledge, clinicians should have confidence to use biosimilars for the treatment of psoriasis.

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Antigenic response to CT‐P13 and infliximab originator in inflammatory bowel disease patients shows similar epitope recognition

Abstract: These results strongly support a similar antigenic profile for infliximab originator and CT-P13, and point toward a safe switching between the two drugs in anti-drug antibody negative patients.

Cited by 21 publications

References 34 publications

SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis

SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis

Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

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