@article {1181, title = {Association between Quality of Life and Visual Acuity in a Randomized Clinical Trial of Patients with Uveitis Taking Antimetabolites.}, journal = {Ocul Immunol Inflamm}, year = {2023}, month = {2023 Feb 07}, pages = {1-9}, abstract = {

PURPOSE: To evaluate how changes in visual acuity are associated with changes in quality of life (QoL) among patients with non-infectious uveitis taking antimetabolites.

METHODS: This secondary analysis of the multicenter First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial involves 216 participants randomized to methotrexate or mycophenolate mofetil. Vision-related (NEI-VFQ and IND-VFQ) and health-related (PCS and MCS SF-36v2) QoL and visual acuity were measured at baseline and 6-month primary endpoint.

RESULTS: Visual acuity was significantly associated and correlated with all QoL measures (Spearman correlation coefficients\ =\ 0.5, 0.5, 0.3, and 0.4 for NEI-VFQ, IND-VFQ, SF-36v2 MCS and PCS, respectively). All observed changes in QoL met or exceeded the minimal clinically important difference definition on each scale. Treatment group was not significantly associated with any QoL measure.

CONCLUSION: By adding insight beyond visual acuity, QoL provides a more comprehensive picture of the patient experience during uveitis treatment. QoL = quality of life; VR-QoL = vision-related quality of life; HR-QoL = health-related quality of life; FAST = First-line Antimetabolites as Corticosteroid Sparing Treatment; NEI-VFQ = National Eye Institute Visual Functioning Questionnaire; IND-VFQ = Indian Visual Functioning Questionnaire; SF-36v2 = Medical Outcomes Study 36-Item Short Form Survey; PCS = physical component score; MCS = mental component score; 95\% CI = 95\% confidence interval; MCID = minimal clinically important difference.

}, issn = {1744-5078}, doi = {10.1080/09273948.2023.2169714}, author = {Chattopadhyay, Aheli and Rathinam, S R and Gonzales, John A and Kelly, Nicole K and Thundikandy, Radhika and Kanakath, Anuradha and Murugan, S Bala and Vedhanayaki, R and Lim, Lyndell L and Suhler, Eric B and Al-Dhibi, Hassan A and Doan, Thuy and Ebert, Caleb D and Porco, Travis C and Acharya, Nisha R} } @article {921, title = {Outcomes of uveitic macular edema in the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial.}, journal = {Ophthalmology}, year = {2022}, month = {2022 Feb 07}, abstract = {

PURPOSE: To evaluate the outcomes of uveitic macular edema at 6 months and 12 months in patients treated with methotrexate or mycophenolate mofetil.

DESIGN: Subanalysis of a block-randomized, observer-masked, multi-center clinical trial.

SUBJECTS/PARTICIPANTS: Patients were enrolled into the First-line Antimetabolites as Steroid-sparing Treatment (FAST) uveitis trial between August 2013 and August 2017.

METHODS/INTERVENTION/TESTING: Patients were randomized to oral methotrexate 25mg weekly or mycophenolate mofetil 1.5g twice daily for 12 months, along with a corticosteroid taper. In addition to standardized clinical examination, all patients underwent spectral domain optical coherence tomography imaging at each visit. At the 6-month primary endpoint, patients who achieved treatment success continued the same treatment for a subsequent 6 months and treatment failures switched to the other treatment group.

MAIN OUTCOME MEASURES: Pre-specified primary outcome at 6 months and 12 months outcomes of central subfield thickness and visual acuity.

RESULTS: Of 216 patients in the FAST Trial, 42 eyes of 30 patients in the methotrexate group and 55 eyes of 41 patients in the mycophenolate group had uveitic macular edema. Baseline median central subfield thickness was 359μm and 342μm in the methotrexate and mycophenolate groups, respectively. At 12 months, for those who stayed on the same treatment, macular thickness decreased from baseline by 23 μm (IQR, -39.0 to 13) and 18 μm (IQR, -68.5 to 9), in the methotrexate and mycophenolate groups, respectively, (P=0.76). In patients who switched treatment at 6 months, macular thickness decreased from baseline by 12.5 μm (IQR, -29.8 to -2.3) and 92 μm (IQR, -240 to -18) in the methotrexate and mycophenolate groups, respectively, (P=0.23). At 12 months, 7/19 (37\%) eyes on methotrexate had resolution of macular edema compared to 15/25 (60\%) eyes on mycophenolate (P=0.10). For those that switched treatments, 8/17 (47\%) eyes on methotrexate and 6/11 (55\%) eyes on mycophenolate had improvement of macular edema, (P=0.92) CONCLUSIONS: Treatment with methotrexate or mycophenolate mofetil for uveitic macular edema results in similar improvements in macular thickness at 6 and 12 months. At 12 months, approximately half of eyes in each antimetabolite group still had persistent macular edema.

}, issn = {1549-4713}, doi = {10.1016/j.ophtha.2022.02.002}, author = {Tsui, Edmund and Rathinam, Sivakumar R and Gonzales, John A and Thundikandy, Radhika and Kanakath, Anuradha and Balamurugan, S and Vedhanayaki, R and Lim, Lyndell L and Suhler, Eric B and Al-Dhibi, Hassan A and Doan, Thuy and Keenan, Jeremy and Ebert, Caleb D and Kim, Eric and Madow, Brian and Porco, Travis C and Acharya, Nisha R} } @article {41, title = {Effect of Corticosteroid-Sparing Treatment With Mycophenolate Mofetil vs Methotrexate on Inflammation in Patients With Uveitis: A Randomized Clinical Trial.}, journal = {JAMA}, volume = {322}, year = {2019}, month = {2019 09 10}, pages = {936-945}, abstract = {

Importance: Methotrexate and mycophenolate mofetil are commonly used immunomodulatory therapies for achieving corticosteroid-sparing control of noninfectious uveitis, but there is uncertainty about which drug is more effective.

Objective: To compare the effect of methotrexate and mycophenolate for achieving corticosteroid-sparing control of noninfectious intermediate uveitis, posterior uveitis, and panuveitis.

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: Patients were randomized to receive oral methotrexate, 25 mg weekly (n = 107), or oral mycophenolate mofetil, 3 g daily (n = 109).

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: Among adults with noninfectious uveitis, the use of mycophenolate mofetil compared with methotrexate as first-line corticosteroid-sparing treatment did not result in superior control of inflammation. Further research is needed to determine if either drug is more effective based on the anatomical subtype of uveitis.

Trial Registration: ClinicalTrials.gov Identifier: NCT01829295.

}, keywords = {Adult, Anti-Inflammatory Agents, Drug Therapy, Combination, Enzyme Inhibitors, Female, Humans, Immunosuppressive Agents, Liver Function Tests, Male, Methotrexate, Middle Aged, Mycophenolic Acid, Prednisolone, Uveitis}, issn = {1538-3598}, doi = {10.1001/jama.2019.12618}, author = {Rathinam, S R and Gonzales, John A and Thundikandy, Radhika and Kanakath, Anuradha and Murugan, S Bala and Vedhanayaki, R and Lim, Lyndell L and Suhler, Eric B and Al-Dhibi, Hassan A and Doan, Thuy and Keenan, Jeremy D and Rao, Maya M and Ebert, Caleb D and Nguyen, Hieu H and Kim, Eric and Porco, Travis C and Acharya, Nisha R} }