Abstract | Importance: Objective: Design, Setting, and Participants: The First-line Antimetabolites as Steroid-sparing Treatment (FAST) uveitis trial screened 265 adults with noninfectious uveitis requiring corticosteroid-sparing immunosuppressive therapy from 9 referral eye centers in India, the United States, Australia, Saudi Arabia, and Mexico between August 22, 2013, and August 16, 2017. Follow-up ended on August 20, 2018. Interventions: Main Outcomes and Measures: The primary outcome was treatment success at 6 months, which was defined as having control of inflammation in both eyes, no more than 7.5 mg prednisone daily and less than or equal to 2 drops of prednisolone acetate 1%, and no treatment failure due to safety or intolerability. Patients underwent follow-up to 12 months while receiving the same treatment or switched to the other antimetabolite, depending on their 6-month outcome. Results: Among 216 patients who were randomized (median age, 38 years; 135 (62.5%) women), 194 (89.8%) completed follow-up through 6 months. Treatment success occurred in 64 (66.7%) patients in the methotrexate group vs 56 (57.1%) in the mycophenolate group (difference, 9.5% [95% CI, -5.3% to 21.8%]; odds ratio [OR], 1.50 [95% CI, 0.81 to 2.81]; P = .20). Among patients with posterior uveitis or panuveitis, treatment success was achieved in 58 (74.4%) in the methotrexate group vs 42 (55.3%) in the mycophenolate group (difference, 19.1% [95% CI, 3.6% to 30.6%]; OR, 2.35 [95% CI, 1.16 to 4.90]; P = .02); whereas among patients with intermediate uveitis treatment success occurred in 6 (33.3%) in the methotrexate group vs 14 (63.6%) in the mycophenolate group (difference, -30.3% [95% CI, -51.6% to 1.1%]; OR, 0.29 [95% CI, 0.08 to 1.05]; P = .07; P for interaction = .004). Elevated liver enzymes were the most common nonserious laboratory adverse event, occurring in 14 patients (13.0%) in the methotrexate group and 8 patients (7.4%) in the mycophenolate group. Conclusions and Relevance: Trial Registration: ClinicalTrials.gov Identifier: NCT01829295.
|
Authors | S R Rathinam, John A Gonzales, Radhika Thundikandy, Anuradha Kanakath, S Bala Murugan, R Vedhanayaki, Lyndell L Lim, Eric B Suhler, Hassan A Al-Dhibi, Thuy Doan, Jeremy D Keenan, Maya M Rao, Caleb D Ebert, Hieu H Nguyen, Eric Kim, Travis C Porco, Nisha R Acharya, FAST Research Group |
Journal | JAMA
(JAMA)
Vol. 322
Issue 10
Pg. 936-945
(09 10 2019)
ISSN: 1538-3598 [Electronic] United States |
PMID | 31503307
(Publication Type: Comparative Study, Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
|
Chemical References |
- Anti-Inflammatory Agents
- Enzyme Inhibitors
- Immunosuppressive Agents
- Prednisolone
- Mycophenolic Acid
- Methotrexate
|
Topics |
- Adult
- Anti-Inflammatory Agents
(administration & dosage)
- Drug Therapy, Combination
- Enzyme Inhibitors
(therapeutic use)
- Female
- Humans
- Immunosuppressive Agents
(administration & dosage, adverse effects, therapeutic use)
- Liver Function Tests
- Male
- Methotrexate
(administration & dosage, adverse effects, therapeutic use)
- Middle Aged
- Mycophenolic Acid
(administration & dosage, adverse effects, therapeutic use)
- Prednisolone
(administration & dosage)
- Uveitis
(drug therapy)
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|