Vision-related (VR) and health-related quality of life (HR QoL) significantly improved among patients who used antimetabolites for treatment of uveitis in a randomized controlled trial, according to research published in Ophthalmology.
While several studies have shown the clinical effectiveness of interventions for uveitis, limited research has been done on the QoL benefits these patients receive from immunosuppressive therapies.
The researchers studied changes in QoL that the 193 patients who reached the primary endpoint with complete QoL data experienced in the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Trial (NCT01829295). The trial included centers in India, the United States, Australia, Saudi Arabia, and Mexico. Researchers compared the effectiveness of methotrexate (25 mg weekly) and mycophenolate mofetil (1.5 g twice daily). The patients had noninfectious intermediate, posterior, or panuveitis in at least 1 eye.
Median National Eye Institute Visual Functioning Questionnaire (NEI-VFQ) score improved from 61.9 at baseline to 81.5 by the primary endpoint, which was 6 months since enrollment (Wilcoxon signed rank test P <.001), with a median change of 12.0 points. Among participants in India, the median Indian Visual Functioning Questionnaire (IND-VFQ) score significantly increased from 69.6 at baseline to 91.1 at primary endpoint (P <.001). Significant improvement was also seen between baseline and the secondary endpoint on both the NEI-VFQ (median score increased 61.9 to 84.0) and IND-VFQ (median score increased 69.6 to 92.8).
Participants’ median Medical Outcomes Study 36-Item Short Form Survey (SF36-v2) physical component score (PCS) score increased from 44.1 to 52.2 (P <0.001) and median SF36-v2 mental component score (MCS) score increased from 41.0 to 47.1 (P =.002) from baseline to the primary endpoint. PCS and MCS significantly improved from baseline to the secondary endpoint (PCS median score changed from 44.1 to 52.4 (P <.001); MCS median score changed from 41.0 to 46.4 (P =.002).
Those who received methotrexate experienced a median change of 3.6 points on the PCS and 4.0 points on the MCS while those who received mycophenolate mofetil experienced a median change in PCS of 3.5 and 2.5 points in MCS. Physical and mental HR QoL was comparable between the groups at the primary endpoint but HR-QoL was significantly higher among participants who achieved treatment success compared with those who did not (PCS: β=3.6, 95% CI=1.6-5.5, P <0.001).
NEI-VFQ and IND-VFQ were highly correlated among patients enrolled in India at baseline, the primary endpoint, and the secondary endpoint . The change in both from baseline to primary endpoint was highly correlated.
Limitations of the study included lack of a control group, possible underlying confounding variables, the possibility that patients lost to follow-up may have had worse outcomes than patients who remained in the trial, and that QoL scales in the analysis were not specifically designed for uveitis patients.
Kelly NK, Chattopadhyay A, Rathinam SR, et al. Health and vision-related quality of life in a randomized controlled trial comparing methotrexate and mycophenolate mofetil for uveitis. Ophthalmol. Published online March 3, 2021. doi:10.1016/j.ophtha.2021.02.024