Latest research on BG-12

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BG-12 side effects

In these trials, BG-12 was well tolerated, the most common side effects being characterized by redness, gastrointestinal symptoms, and headaches. [source, 2016]
Results concerning comparison between BG-12 at a dose of 240 mg three times daily and placebo from Kappos et al. study [38, 39] were excluded from the meta-analysis because the reported outcomes were extracted at week 24, whereas results in studies DEFINE [15-19]and CONFIRM [20-24] were obtained at 96 weeks of treatment period; therefore, they should not be aggregated together. [source, 2014]
The overall result of the meta-analysis of BG-12 did not reveal any significant difference in frequency of death from any cause between both doses of BG-12 and the placebo (for BG-12 twice daily ORfixed=1.00 [95% CI: 0.14–7.15], p=1.00; for BG-12 three times daily ORfixed=1.70 [95% CI: 0.22–12.98], p=0.61) (Fig. [source, 2014]
Both dosages of the study drug BG-12 administered as monotherapy showed also an acceptable safety profile, comparable to placebo in respect to the risk of any adverse events, discontinuations due to adverse events or deaths from any cause. [source, 2014]
Remarkably, patients treated with BG-12 did not show an increased risk of serious infections or malignancies, even though neuroprotective action of this agent is probably associated with the depletion of white blood cells [9, 15, 20]. [source, 2014]
We should emphasize that dose finding in the Phase IIb study led to the using the BG-12 at the dosages of 240 mg twice or thrice daily (with a total daily dose of 480 and 720 mg, respectively) in the phase III RCTs, although according to the FDA's approval, the licensed dosage is 120 mg twice daily that should be increased to the maintenance dose of 240 mg twice daily after 7 days. [source, 2014]
As expected, the mean white cell count and lymphocyte count decreased in patients treated with BG-12. [source, 2014]
Overwhelming decreases of the white cell count and lymphocyte count (3.0 × 109/L and 0.5 × 109/L, respectively) occurred in 4%–10% of patients treated with BG-12. [source, 2014]
The overall incidence of both malignant neoplasms and opportunistic infections was not increased in patients receiving BG-12. [source, 2013]
As expected, the mean white cell count and lymphocyte count decreased in patients treated with BG-12. [source, 2013]