Adalimumab Monotherapy or Combination Therapy With Methotrexate in Paediatric Uveitis: Data From the AIDA Network Uveitis Registry.
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Gaggiano Carla, de-la-Torre Alejandra, Guerriero Silvana, Costi Stefania, Ragab Gaafar, Paroli Maria Pia, Del Giudice Emanuela, Breda Luciana, La Bella Saverio, Cattalini Marco, Maggio Maria Cristina, Fonollosa Alex, Carreño Ester, Tarsia Maria, Dammacco Rosanna, Hashad Soad, Vitale Antonio, Fotis Lampros, Gentileschi Stefano, Minoia Francesca, Mejía-Salgado Germán, Etayari Halah, Saboya-Galindo Paola, Bernal-Valencia María Andrea, Civino Adele, Chimenti Maria Sole, Caggiano Valeria, Gicchino Maria Francesca, Sota Jurgen, Mauro Angela, Lopalco Giuseppe, Murthy Kalpana Babu, Hegazy Mohamed Tharwat, Gupta Vishali, La Torre Francesco, Amin Rana Hussein, Frediani Bruno, Tosi Gian Marco, Cantarini Luca, Fabiani Claudia, AIDA Network
Аннотация
METHODS: Registry-based observational study. Children receiving ADA for active uveitis were divided into the ADA monotherapy group (group 1) and the ADA plus MTX combination group (group 2).
RESULTS: Eighty four children were enrolled (146 eyes): 22 in group 1 (26.2%) and 62 in group 2 (73.8%). ADA effectiveness was complete in 48 children (57.1%), partial in 23 (27.4%) and absent in 4 (5.3%), without any differences across the groups (p = 0.89). Fewer relapses per 100 PY occurred after ADA treatment both in group 1 (280.0 vs. 23.0, p = 0.005) and in group 2 (297.9 vs. 86.0, p < 0.001). The final BCVA was similar between groups 1 and 2 [median 1.0 (IQR 0.3) and 1.0 (IQR 0.3), respectively, p = 0.55]. A statistically significant steroid-sparing effect was observed in the entire cohort and in group 2 at the 6-month (p = 0.01 and p = 0.01), 12-month (p = 0.02 and p = 0.02), and last follow-up (p = 0.045 and p = 0.045). The estimated ADA retention rate was 97.1% at 12 months, 87.7% at 24 months, and 82.6% at 36 months, without a statistically significant difference among the groups (p = 0.77).
CONCLUSIONS: ADA monotherapy could be equally effective as its combination with MTX in both preventing uveitis relapses and preserving visual acuity in paediatric NIU, with comparable retention rates over 36 months of treatment. The steroid-sparing effect of ADA monotherapy warrants further extensive evaluation to define its optimal placement in the therapeutic strategy for paediatric NIU.