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Adalimumab Monotherapy or Combination Therapy With Methotrexate in Paediatric Uveitis: Data From the AIDA Network
Carla Gaggiano1, Alejandra de-la-Torre2, Silvana Guerriero3
1Rheumatology Unit, Department of Medical Sciences, Surgery and Neuroscience, University of Siena, Siena University Hospital [European Reference Network (ERN) for Rare Immunodeficiency, Autoinflammatory and Autoimmune Diseases (RITA) Center], Siena, Italy.
Insights
Adalimumab (ADA) monotherapy is as effective as combination therapy with methotrexate (MTX) for treating pediatric noninfectious uveitis (NIU). Both treatments reduce relapses and preserve visual acuity, with similar long-term retention rates.
Area of Science:
- Ophthalmology
- Immunology
- Pediatrics
Background:
- Pediatric noninfectious uveitis (NIU) requires effective treatment to prevent vision loss.
- Adalimumab (ADA) is a biologic agent used for NIU, but its optimal use (monotherapy vs. combination therapy) is under investigation.
Purpose of the Study:
- To compare the effectiveness of adalimumab (ADA) monotherapy versus ADA in combination with methotrexate (MTX) for treating pediatric noninfectious uveitis (NIU).
Main Methods:
- A registry-based observational study included children with active NIU treated with ADA.
- Patients were divided into two groups: ADA monotherapy and ADA plus MTX combination therapy.
- Effectiveness was assessed by uveitis control, relapse rates, visual acuity, and steroid-sparing effects.
Main Results:
- Eighty-four children were analyzed, with 22 in the ADA monotherapy group and 62 in the ADA plus MTX group.
- Overall effectiveness (complete, partial, absent) did not differ significantly between groups (p=0.89).
- Both treatment strategies significantly reduced uveitis relapses and demonstrated a steroid-sparing effect, with comparable final visual acuity and ADA retention rates up to 36 months.
Conclusions:
- Adalimumab monotherapy appears to be as effective as combination therapy with methotrexate in managing pediatric NIU.
- Both approaches show comparable efficacy in preventing relapses, preserving visual acuity, and maintaining treatment adherence.
- Further research is needed to fully define the role of ADA monotherapy in the therapeutic strategy for pediatric NIU.
Background:
The study objective was to compare the effectiveness of adalimumab (ADA) in monotherapy and in combination with methotrexate (MTX) for paediatric noninfectious uveitis (NIU).
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.
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