. Author manuscript; available in PMC: 2024 Mar 8.

Published in final edited form as: J Rheumatol. 2022 Dec 1;50(3):438–450. doi: 10.3899/jrheum.220317

Table 4.

Advanced therapy PBO-controlled RCTs in noninfectious uveitis. Efficacy and safety in new studies from February 2013 to August 2020.

Medication Class vs PBO	Author, Year	n	(1) Primary and (2) Key Secondary Endpoints	Endpoints Met	Study Limitations and Population

ADA	Jaffe 2016⁴²	117	(1) Time to treatment failure occurring at or after wk 6 (2) Change in anterior chamber cell grade, vitreous haze grade, and BCVA (2) AEs and SAEs	Patients on ADA less likely to have treatment failure than PBO (24 wks vs 13 wks). Change better in ADA group than PBO. More AEs and SAEs for ADA vs PBO.	Patients with active noninfectious uveitis. Patients assigned to receive ADA (a loading dose of 80 mg followed by a dose of 40 mg every 2 wks) or matched PBO. All patients received a mandatory prednisone burst followed by tapering of prednisone over the course of 15 wks.
	Nguyen 2016⁴³	226	(1) Time to treatment failure (2) Risk of uveitis flare and loss of visual acuity	Treatment failure in 39% patients in the ADA group vs 55% patients in the PBO group Time to treatment failure: ADA > 18 months vs 8.3 months in PBO. ADA significantly lowered risk of uveitic flare or loss of visual acuity.	Patients with inactive noninfectious uveitis controlled by corticosteroids (VISUAL II). ADA: n = 115 Control: n = 111
	Mackensen 2018⁴⁴	25	(1) Improved BCVA (> 2 lines) at 3 months	ADA superior over PBO in severe ocular inflammation.	Patients with different forms of refractory uveitis. ADA: n = 10 Control: n = 15
SEC	Letko 2015⁴⁵	37	(1) % of patients with treatment response (2) % of patients with remission	30 mg/kg + 10 mg/kg produced higher response and remission rates than 300 mg + 30 mg/kg IV dose. Statistically and clinically superior to 300 mg SC dose.	Patients with noninfectious uveitis requiring steroid-sparing immunosuppressive therapy. SEC 300 mg SC vs 30 mg/kg IV vs 10 mg/kg IV vs saline IV/SC (PBO).
MTX vs MMF^a	Niemeyer 2017⁴⁶	80	(1) Treatment success (BCVA) (2) QOL (IND-VFQ, SF-36)	No significant difference between 2 arms for change in BCVA. Significant overall improvement in visual acuity and function in patients for both arms. However, mental health score of SF-36 decreased.	Patients with intermediate, posterior, and panuveitis.

No PBO arm. ADA: adalimumab; AE: adverse event; BCVA: best corrected visual acuity; IND-VFQ: Indian Vision Function Questionnaire; IV: intravenous; MMF: myco- phenolate mofetil; MTX: methotrexate; PBO: placebo; QOL: quality of life; RCT: randomized controlled trials; SAE: serious adverse events; SC: subcutaneous; SEC: secukinumab; SF-36: 36-item Short Form Health Survey.