Background Time to treatment failure is the primary endpoint in the VISUAL-1 clinical trial (NCT01138657) of patients with non-infectious intermediate-, posterior- and pan-uveitis (NIIPPU); however, the relationship between the treatment failure (TF) criteria and patient-reported outcome of visual functioning is not well understood.
Objectives To examine the relationship between TF and vision-related quality of life (QoL) as assessed by the Visual Functioning Questionnaire 25 (VFQ-25) among patients with NIIPPU.
Methods The VISUAL-1 clinical trial was a randomized, placebo-controlled, 80-week study designed to investigate the efficacy and safety of adalimumab in patients with active NIIPPU. Patients were examined at scheduled study visits for TF at and after week 6. TF was assessed using 4 criteria: presence of inflammatory, chorioretinal, and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade, and visual acuity (VA). Patients with TF due to 1, 2, 3, and 4 of these components met 1 of 4 criteria, 2 of 4 criteria, 3 of 4 criteria, and all 4 criteria, respectively. The VFQ-25 measures 12 health domains (11 vision-related; 1 general health–related) and was used to assess the effect of ocular disease on vision-related QoL from the patient's perspective. VFQ-25 total score was the mean of 11 vision-related domains. Scores ranged from 0 (worst vision) to 100 (best vision). Analyses were conducted for patients with 1, 2, 3, and 4 components, and for patients with no component (non-failure). Changes in VFQ-25 total and subdomain scores from best state prior to week 6 to final visit were calculated for each component, at least 1 component, and no component (non-failure). Analysis of covariance (adjusting for best state prior to week 6) was used to assess the association between VFQ-25 score and 1, 2, 3, or 4 components. Missing data were imputed using last observation carried forward.
Results Data from 203 patients were analyzed. Unadjusted mean change in VFQ 25 total score was -4.92 for at least 1 component compared with 0.19 for non-failure; unadjusted mean change was −3.90, −5.09, −11.1, and −13.88, for 1, 2, 3, and 4 components, respectively. Adjusted change in VFQ-25 score from best state prior to week 6 to final visit was −3.9 (P<.0001) for each additional component. When assessing patients by component, the greatest change in VFQ-25 total score was seen for VA (−7.99) followed by VH grade (−3.29), AC cell grade (−2.8), and retinal vascular lesion (−2.76). In general, results were similar for the VFQ-25 subdomain scores.
Conclusions Clinically meaningful decreases in VFQ-25 scores among patients experiencing TF were substantial1 supporting TF as a relevant outcome from the patient perspective. Among causes for TF, the loss of VA had the greatest impact on the QoL, the other causes for TF had a lesser effect.
Naik RK, et al. Qual Life Res. 2013;22:2801–8.
Acknowledgement Financial support for the study and medical writing (Joann Hettasch, Arbor Communications, Inc) were provided by AbbVie Inc. AbbVie participated in the interpretation of data, review, and approval of the abstract; all authors contributed to the development of the publication and maintained control over the final content.
Disclosure of Interest A. Brézin Consultant for: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, S. Tari Shareholder of: AbbVie, Employee of: AbbVie, M. Skup Shareholder of: AbbVie, Employee of: AbbVie, A. Joshi Shareholder of: AbbVie, Employee of: AbbVie
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