Search

ObjectiveEpratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double-blind, placebo-controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE).MethodsPatients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti-double-stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG-2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5-60 mg/day). BILAG-2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12-week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG-based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG-2004 score, no worsening in the BILAG-2004 score, SLEDAI-2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders.ResultsIn the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793 patients and 791 patients, respectively, were randomized, 786 (99.1%) and 788 (99.6%), respectively, received study medication, and 528 (66.6%) and 533 (67.4%), respectively, completed the study. There was no statistically significant difference in the primary end point between the groups, with the week 48 BICLA response rates being similar between the epratuzumab groups and the placebo group (response rates ranging from 33.5% to 39.8%). No new safety signals were identified.ConclusionIn patients with moderate or severely active SLE, treatment with epratuzumab + standard therapy did not result in improvements in response rates over that observed in the placebo + standard therapy group.

The human visual analyzer is a high form of evolution. Some jellyfish can distinguish light and dark objects with sensitive cells. Squids, octopuses, and nautiluses from Cephalopods family have eyes with which they can see objects. Visual information is processed in the brain. In fishes, the visual analyzer evolved. Fishes living below 100 m depth inhabit a world with blue light. The authors consider the evolution of vision in these fishes due to the lowest absorption of blue and violet colors of electromagnetic waves from the optical spectrum. Subsequently, on land, in humans vision evolved towards the green color. Green is the most prevalent color on the land. In humans, three light-sensitive cones evolved – S, M, and L. S cones are most sensitive to blue, M – to green, and L – to red color in the spectrum. Some humans retain sensitivity of S to genetic changes and disorders. Additive color mixing is a high form of color perception in humans. The additive mixing of different colors achieves a new color in the human visual analyzer. Remarkably, different individuals perceive observed images in varying manners. Mixing neighboring colors on the spectrum gives one, two, or three colors. This process is estimated using graphical modeling. The graphical modeling with two colors allows for the creation of additive colors. One, two, or three additive colors can be obtained. The production of colors results from the light sensitivity of S, M, and L cones. An analysis that physically demonstrates the mixing of green and red colors, resulting in the colors yellow or orange. When blue and red are mixed, the resulting colors are green, yellow, and orange is proposed. The additive mixing of blue and yellow gives green. The subjective nature of visual perception, influenced by the viewer’s heightened sensitivity to one of the colors, becomes evident in the presence of two colors. Notably, when the background is violet, the sensitivity of the blue cones diminishes. [ABSTRACT FROM AUTHOR]