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

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).