Background: Conjunctivitis is among the most frequent adverse events (AEs) emerged in clinical trials for all biologic drugs approved for atopic dermatitis (AD). However, real-world comparative data on the incidence, risk factors, and management of conjunctivitis remain limited. Objective: We aimed to compare the incidence, clinical features, and management of conjunctivitis in patients with moderate-to-severe AD treated with dupilumab or tralokinumab in a real-life setting. Patients and Methods: A multicenter, retrospective, observational study including adult patients with moderate-to-severe AD treated with dupilumab or tralokinumab for at least 16 weeks was carried out. Demographic, clinical, and therapeutic data were collected from 35 dermatological referral centers across Italy. Conjunctivitis incidence, severity, time to onset, and ophthalmologic management were analyzed and compared between treatment groups. Results: A total of 6668 patients were included (5899 on dupilumab and 769 on tralokinumab). Conjunctivitis occurred in 10.76% of dupilumab-treated and 12.61% of tralokinumab-treated patients, with no statistically significant difference in overall incidence. However, time to onset was significantly shorter with tralokinumab than with dupilumab (15.3 ± 14.5 weeks vs. 35.5 ± 45.2 weeks, respectively; p < 0.0001). Ophthalmologic management strategies were similar between groups, mainly involving lubricants and corticosteroid-based eye drops. Dupilumab-treated patients more frequently discontinued or switched treatment due to conjunctivitis than tralokinumab patients (25.4% vs. 14.4%, respectively; p < 0.05). Conclusions: Conjunctivitis represents a relatively frequent AE in patients with AD receiving dupilumab or tralokinumab. However, earlier onset of conjunctivitis with tralokinumab and higher discontinuation rates with dupilumab suggest differing tolerability profiles. Early recognition of ocular symptoms is essential, and dermatologists should promptly initiate supportive eye care and refer to ophthalmologists when appropriate to avoid unnecessary treatment interruptions.
Incidence, Risk Factors, and Management of Conjunctivitis in Atopic Dermatitis Patients Treated With Dupilumab or Tralokinumab: Results From a Multicenter, Observational, Retrospective Study / Potestio, L.; Patruno, C.; Del Gaudio, M.; Ortoncelli, M.; Ribero, S.; Barei, F.; Ferrucci, S. M.; Bonzano, L.; Trave, I.; Guanti, M. B.; Gurioli, C.; Piraccini, B. M.; Gori, N.; Ippoliti, E.; Peris, K.; Grigolato, L.; Rossi, M.; Foti, C.; Romita, P.; Tirone, B.; Nettis, E.; Esposito, M.; Fargnoli, M. C.; Magnanimi, L. M.; Pezzolo, E.; Hansel, K.; Stingeni, L.; Satta, R.; Mariano, M.; Pigliacelli, F.; Margiotta, F. M.; Romanelli, M.; Ingurgio, R. C.; Costanzo, A.; Narcisi, A.; Corazza, M.; Antiga, E.; Morrone, P.; Rubegni, P.; Calabrese, L.; Lazzeri, L.; Rubegni, G.; Guarneri, F.; Zerbinati, N.; Carugno, A.; Puca, R. V.; Sarno, O.; Marasca, C.; Martina, E.; Di Vico, F.; Napolitano, M.. - In: INTERNATIONAL JOURNAL OF DERMATOLOGY. - ISSN 0011-9059. - (2025). [10.1111/ijd.70027]
Incidence, Risk Factors, and Management of Conjunctivitis in Atopic Dermatitis Patients Treated With Dupilumab or Tralokinumab: Results From a Multicenter, Observational, Retrospective Study
Potestio L.;Del Gaudio M.;Napolitano M.
2025
Abstract
Background: Conjunctivitis is among the most frequent adverse events (AEs) emerged in clinical trials for all biologic drugs approved for atopic dermatitis (AD). However, real-world comparative data on the incidence, risk factors, and management of conjunctivitis remain limited. Objective: We aimed to compare the incidence, clinical features, and management of conjunctivitis in patients with moderate-to-severe AD treated with dupilumab or tralokinumab in a real-life setting. Patients and Methods: A multicenter, retrospective, observational study including adult patients with moderate-to-severe AD treated with dupilumab or tralokinumab for at least 16 weeks was carried out. Demographic, clinical, and therapeutic data were collected from 35 dermatological referral centers across Italy. Conjunctivitis incidence, severity, time to onset, and ophthalmologic management were analyzed and compared between treatment groups. Results: A total of 6668 patients were included (5899 on dupilumab and 769 on tralokinumab). Conjunctivitis occurred in 10.76% of dupilumab-treated and 12.61% of tralokinumab-treated patients, with no statistically significant difference in overall incidence. However, time to onset was significantly shorter with tralokinumab than with dupilumab (15.3 ± 14.5 weeks vs. 35.5 ± 45.2 weeks, respectively; p < 0.0001). Ophthalmologic management strategies were similar between groups, mainly involving lubricants and corticosteroid-based eye drops. Dupilumab-treated patients more frequently discontinued or switched treatment due to conjunctivitis than tralokinumab patients (25.4% vs. 14.4%, respectively; p < 0.05). Conclusions: Conjunctivitis represents a relatively frequent AE in patients with AD receiving dupilumab or tralokinumab. However, earlier onset of conjunctivitis with tralokinumab and higher discontinuation rates with dupilumab suggest differing tolerability profiles. Early recognition of ocular symptoms is essential, and dermatologists should promptly initiate supportive eye care and refer to ophthalmologists when appropriate to avoid unnecessary treatment interruptions.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
