In Macular Edema, No Difference in VALS or CST at Month 24 for Those Treated With Bevacizumab or Aflibercept

Researchers report that there were no differences in visual acuity letter score (VALS) and central subfield thickness (CST) outcomes at month 24 between patients treated with bevacizumab and those treated with aflibercept in the SCORE2 study.
The Center for Biosimilars Staff
November 09, 2019
Anti–vascular endothelial growth factor (anti-VEGF) therapy has emerged as the standard of care for macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, and although multiple anti-VEGF therapies carry indications for treating eye disorders, off-label bevacizumab is also increasingly used because of its favorable cost. The fact that biosimilar bevacizumab is now available may potentially increase the use of this agent in eye disorders.

Earlier this year, researchers shared findings on patient-reported visual function in a secondary analysis of the randomized SCORE2 trial of bevacizumab versus aflibercept in 346 patients with macular edema.1 Those findings showed that, in terms of patient-reported outcomes, treatment with the off-label bevacizumab was noninferior to treatment with the on-label aflibercept at 6 months.

Now, in another secondary analysis of the same trial, researchers report that there were no differences in visual acuity letter score (VALS) and central subfield thickness (CST) outcomes at month 24 between patients treated with bevacizumab and those treated with aflibercept.2

After month 12 of the SCORE2 study, physicians could treat patients as deemed necessary, rather than on a specified dosing schedule, and with any agent. In total, 236 patients completed a protocol visit at month 24. Among the 121 of 236 completers treated only with aflibercept or only with bevacizumab during months 12 to 24, the mean (SD) number of injections was 4.7 (2.5) for the aflibercept group and 5.5 (2.8) for the bevacizumab group. 
 
Among patients with a month 24 visit, the mean (SD) VALS improved from baseline to 12 months by 21.6 (14.5) in the aflibercept group versus 21.9 (16.6) in the bevacizumab group (treatment difference, −0.3; 99% CI, −5.6 to 4.9).

Mean (SD) VALS then worsened by 7.6 (17.5) in the aflibercept group and 7.5 (14.5) in the bevacizumab group (treatment difference, −0.1; 99% CI, −5.6 to 5.3) at month 24. 

The mean (SD) CST improved from baseline to 12 months by 394 (231) mcm in the aflibercept group versus 420 (274) mcm in the bevacizumab group (treatment difference, 26 mcm; 99% CI, −62 mcm to 114 mcm).

Then, the mean (SD) CST worsened from by a mean of 58 (192) mcm in the aflibercept group versus 48 (186) mcm in the bevacizumab group (treatment difference, 10 mcm; 99% CI, −58 mcm to 78 mcm) at month 24.

“The original treatment assignment was not associated with significant differences in VALS or CST at month 24,” write the authors, but they note that “Most of the improvement in VALS and CST observed in the SCORE2 trial occurred during the first 6 months of the study, when treatment was administered monthly. This initial improvement decreased during months 12 to 24, when participants went off the treatment protocol.”

That finding suggests, say the authors, that patients should be monitored closely over at least a 2-year period to optimize anti-VEGF therapy, and they note that the fact that some patients were lost to follow-up warrants caution.

Reference
1. Scott IU, VanVeldhuisen PC, Barton F, et al. Patient-reported visual function outcomes after anti–vascular endothelial growth factor therapy for macular edema due to central retinal or hemiretinal vein occlusion: preplanned secondary analysis of a randomized clinical trial [published online June 6, 2019]. JAMA Ophthalmol. doi: 10.1001/jamaophthalmol.2019.1519.

2. Scott IU, Oden NL, VanVeldhuisen PC, et al. Month 24 outcomes after treatment initiation with anti–vascular endothelial growth factor therapy for macular edema due to central retinal or hemiretinal vein occlusion: SCORE2 report 10: a secondary analysis of the SCORE2 randomized clinical trial [published online October 10, 2019]. JAMA Ophthalmol. doi: 10.1001/jamaophthalmol.2019.3947.

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