Randomized Controlled Study to Evaluate the Efficacy of Adalimumab in Patients with Different Forms of Refractory Uveitis

Ocul Immunol Inflamm. 2018;26(7):1015-1022. doi: 10.1080/09273948.2017.1411518. Epub 2017 Dec 29.


Purpose: TNF alpha inhibitors have revolutionized the care of vision-threatening uveitis. This study evaluated the efficacy of adalimumab (ADA) for the treatment of refractory noninfectious uveitis.

Design: Randomized, prospective, controlled, two-center clinical trial Methods: Patients with active uveitis despite combined oral low-dose prednisolone and immunosuppression were randomized for additional ADA with corticosteroids in a fixed tapering regime, or corticosteroids only. Primary outcome measure at three months was improved best-corrected visual acuity (BCVA; >2 lines). In case of treatment failure, switch to the other arm was possible.

Results: Twenty-five patients (10 ADA, 15 controls) were included. BCVA increased with ADA by > 2 lines in 6/10 patients (60%; mean increase of 0.23 logMAR), but in only 2/15 from controls (13%, mean increase of 0.04 logMAR, Fisher´s exact test p = 0.00221).

Conclusions: The results show superiority of ADA over controls in severe ocular inflammation including anterior uveitis.

Keywords: Adalimumab; anterior uveitis; biological therapy; clinical trial; uveitis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adalimumab / adverse effects
  • Adalimumab / therapeutic use*
  • Adult
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Female
  • Glucocorticoids / therapeutic use
  • Humans
  • Male
  • Prospective Studies
  • Treatment Outcome
  • Uveitis / classification
  • Uveitis / drug therapy*
  • Uveitis / physiopathology
  • Visual Acuity


  • Anti-Inflammatory Agents
  • Glucocorticoids
  • Adalimumab