Comparative Study of Adalimumab, Infliximab and Certolizumab Pegol in the Treatment of Cystoid Macular Edema Due to Behçet’S Desease

24 Pages Posted: 27 Jul 2024

See all articles by Nuria Barroso García

Nuria Barroso García

affiliation not provided to SSRN

José Luis Martín-Varillas

affiliation not provided to SSRN

Iván Ferraz-Amaro

Hospital Universitario de Canarias

Lara Sánchez-Bilbao

affiliation not provided to SSRN

Adrián Martín-Gutiérrez

affiliation not provided to SSRN

Alfredo Adán

Hospital Clínic de Barcelona

Inés Hernanz Rodríguez

Universidad de Barcelona - Hospital Clínic Barcelona

Emma Beltrán Catalán

Hospital del Mar

Miguel Cordero Coma

affiliation not provided to SSRN

David Díaz Valle

affiliation not provided to SSRN

Marisa Hernández Garfella

affiliation not provided to SSRN

Lucía Martínez Costa

affiliation not provided to SSRN

Manuel Díaz Llopis

affiliation not provided to SSRN

José M. Herreras

affiliation not provided to SSRN

Olga Maíz Alonso

affiliation not provided to SSRN

Ignacio Torre Salaberri

affiliation not provided to SSRN

Antonio Atanes Sandoval

Instituto de Investigación Biomédica de A Coruña - Complexo Hospitalario Universitario A Coruña

Santos Insúa

affiliation not provided to SSRN

Raquel Almodóvar González

affiliation not provided to SSRN

Patricia Fanlo

Universidad Pública de Navarra - Complejo Hospitalario de Navarra

Juan Ramón De Dios Jiménez De Aberasturi

affiliation not provided to SSRN

Ángel García Aparicio

Hospital Universitario de Móstoles

Sergio Rodríguez Montero

Hospital Universitario Virgen de Valme

Vega Jovani Casano

Hospital General Universitario de Alicante

Patricia Moya-Alvarado

Hospital de la Santa Creu i Sant Pau

Eva Peña Sainz-Pardo

Instituto de Investigación Sanitaria Hospital "12 de Octubre" - Hospital Universitario 12 de Octubre

Vanesa Calvo Río

affiliation not provided to SSRN

Rosalia Demetrio Pablo

affiliation not provided to SSRN

José L. Hernández

Hospital Marqués de Valdecilla - Internal Medicine Division

Ricardo Blanco

Research Institute Marqués de Valdecilla (IDIVAL)

Abstract

Introduction: Cystoid Macular Edema (CME) is the leading cause of blindness in non-infectious uveitis. Behçet’s disease (BD) is one of the diseases most frequently associated with CME.Objectives: to compare efficacy and safety of Adalimumab (ADA), Infliximab (IFX) and Certolizumab (CZP) in CME refractory due to BD.Methods: multicenter study of patients with CME secondary to BD refractory to glucocorticoids (GC) and at least 1 conventional immunosuppressant. All patients had CME (OCT>300µ) at baseline. From baseline up to 2 years, efficacy of ADA, IFX and CZP was assessed with the following ocular parameters: macular thickness (µm), visual acuity (BCVA), anterior chamber (AC) cells and vitritis. Mixed-effects regression models were applied.Results: a total of 50 patients (75 eyes) were studied (ADA=25; IFX= 15 and CZP= 10). No significant differences in demographic parameters were observed in the three groups. However, patients in the CZP group had a significantly longer time from diagnosis to drug initiation (72 [36-120] months, p=0.03) and had received a greater mean of biological treatments (1.7±1.1) than the ADA and IFX groups. In CZP group, ADA and IFX were used previously in 7 patients.A rapid and maintained improvement in macular thickness was observed after 2 years of follow-up in the three groups with no statistically significant differences between them. Improvement in BCVA, AC cells, and vitritis was also noted. No serious adverse events were observed in CZP group. One case of bacteremia was reported in the ADA group.Conclusions: ADA, IFX and CZP seem to be effective and safe in refractory CME due to BD. CZP appears effective even in patients with inadequate response to ADA and/or IFX.

Note:
Funding Information: None.

Declaration of Interests: Dr. José Luis Martín-Varillas received grants/research support from AbbVie, Pfizer, Lilly, Celgene, Janssen, and UCB Pharma. Dr. Lara Sánchez-Bilbao received grants/research support from Roche, Lilly, and Pfizer. Dr. Iván Ferraz Amaro has received grants/research supports from Abbott, MSD, Jansen and Roche and had consultation fees/participation in company-sponsored speaker´s bureau from Abbott, Pfizer, Roche, Sanofi, Sobi, Amgen, Celgene and MSD. Dr. Emma Beltrán Catalán had consultation fees/participation in the company-sponsored speaker’s bureau from Abbvie, Amgen, Janssen, MSD, Pfizer, Lilly, Novartis and UCB. Dr. Miguel Cordero-Coma was a lecturer for Abbvie, Merck Sharp & Dohme, Allergan and UCB. He also participated in Advisory Boards for Abbvie and Allergan. He also had travel grants from Abbvie, UCB and Allergan. Dr. Patricia Fanlo received grants/research supports from Sobi and Novartis and had consultation fees/participation in the company-sponsored speaker’s bureau from Sobi and Novartis. Dr. Vanesa Calvo-Río received grants/research support from MSD and Roche and had consultation fees/participation in the company-sponsored speaker’s bureau from AbbVie, Lilly, Celgene, Grünenthal, and UCB Pharma. Prof. JL Hernández received grants/research support from Amgen and participation in company-sponsored speaker’s bureau from Amgen, MSD, and Novartis. Dr. Ricardo Blanco received grants/research support from AbbVie, MSD, and Roche, and had consultation fees/participation in a company-sponsored speaker’s bureau from AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD. No other conflicts.

Ethics Approval Statement: A written consent was obtained from all patients who received treatment with IFX and CZP as off-label drugs by the EMA for the treatment of non-infectious non-anterior uveitis. Besides, the corresponding Ethics committee approval was obtained (CEIm 2023.439).

Suggested Citation

Barroso García, Nuria and Martín-Varillas, José Luis and Ferraz-Amaro, Iván and Sánchez-Bilbao, Lara and Martín-Gutiérrez, Adrián and Adán, Alfredo and Hernanz Rodríguez, Inés and Beltrán Catalán, Emma and Cordero Coma, Miguel and Díaz Valle, David and Hernández Garfella, Marisa and Martínez Costa, Lucía and Díaz Llopis, Manuel and Herreras, José M. and Maíz Alonso, Olga and Torre Salaberri, Ignacio and Atanes Sandoval, Antonio and Insúa, Santos and Almodóvar González, Raquel and Fanlo, Patricia and De Dios Jiménez De Aberasturi, Juan Ramón and García Aparicio, Ángel and Rodríguez Montero, Sergio and Jovani Casano, Vega and Moya-Alvarado, Patricia and Peña Sainz-Pardo, Eva and Calvo Río, Vanesa and Demetrio Pablo, Rosalia and Hernández, José L. and Blanco, Ricardo, Comparative Study of Adalimumab, Infliximab and Certolizumab Pegol in the Treatment of Cystoid Macular Edema Due to Behçet’S Desease. Available at SSRN: https://ssrn.com/abstract=4897614 or http://dx.doi.org/10.2139/ssrn.4897614

Nuria Barroso García

affiliation not provided to SSRN ( email )

No Address Available

José Luis Martín-Varillas

affiliation not provided to SSRN ( email )

No Address Available

Iván Ferraz-Amaro

Hospital Universitario de Canarias ( email )

Lara Sánchez-Bilbao

affiliation not provided to SSRN ( email )

No Address Available

Adrián Martín-Gutiérrez

affiliation not provided to SSRN ( email )

No Address Available

Alfredo Adán

Hospital Clínic de Barcelona ( email )

Barcelona
Spain

Inés Hernanz Rodríguez

Universidad de Barcelona - Hospital Clínic Barcelona ( email )

Barcelona
Spain

Emma Beltrán Catalán

Hospital del Mar ( email )

Barcelona
Spain

Miguel Cordero Coma

affiliation not provided to SSRN ( email )

No Address Available

David Díaz Valle

affiliation not provided to SSRN ( email )

No Address Available

Marisa Hernández Garfella

affiliation not provided to SSRN ( email )

No Address Available

Lucía Martínez Costa

affiliation not provided to SSRN ( email )

No Address Available

Manuel Díaz Llopis

affiliation not provided to SSRN ( email )

No Address Available

José M. Herreras

affiliation not provided to SSRN ( email )

No Address Available

Olga Maíz Alonso

affiliation not provided to SSRN ( email )

No Address Available

Ignacio Torre Salaberri

affiliation not provided to SSRN ( email )

No Address Available

Antonio Atanes Sandoval

Instituto de Investigación Biomédica de A Coruña - Complexo Hospitalario Universitario A Coruña ( email )

A Coruña
Spain

Santos Insúa

affiliation not provided to SSRN ( email )

No Address Available

Raquel Almodóvar González

affiliation not provided to SSRN ( email )

No Address Available

Patricia Fanlo

Universidad Pública de Navarra - Complejo Hospitalario de Navarra ( email )

Pamplona
Spain

Juan Ramón De Dios Jiménez De Aberasturi

affiliation not provided to SSRN ( email )

No Address Available

Ángel García Aparicio

Hospital Universitario de Móstoles ( email )

Spain

Sergio Rodríguez Montero

Hospital Universitario Virgen de Valme ( email )

Spain

Vega Jovani Casano

Hospital General Universitario de Alicante ( email )

Patricia Moya-Alvarado

Hospital de la Santa Creu i Sant Pau ( email )

Oncology Service
Barcelona
Spain

Eva Peña Sainz-Pardo

Instituto de Investigación Sanitaria Hospital "12 de Octubre" - Hospital Universitario 12 de Octubre ( email )

Madrid
Spain

Vanesa Calvo Río

affiliation not provided to SSRN ( email )

No Address Available

Rosalia Demetrio Pablo

affiliation not provided to SSRN ( email )

No Address Available

José L. Hernández

Hospital Marqués de Valdecilla - Internal Medicine Division ( email )

Ricardo Blanco (Contact Author)

Research Institute Marqués de Valdecilla (IDIVAL) ( email )

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