Sign in Subscribe
Drugs

Celgene Reports Statistically Significant Weight Gain in Patients with AIDS-Associated Weight Loss

Strategic Insights

— 1 min read

Celgene Corporation recently announced statistically significant weight gain in patients with AIDS-associated weight loss after administration of THALOMID(TM)(thalidomide) for up to six months. The study, presented at the 12th Annual World AIDS Conference in Geneva, showed that patients who received the treatment experienced a mean weight gain of 13.6 pounds, or 10 percent, over a 28-week period. Approximately half of these patients returned to their pre-morbid weight, and weight gain continued through 68 weeks of therapy. The study's findings support Celgene's plan to submit a new drug application (NDA) for the use of THALOMID(TM)(thalidomide) in AIDS wasting.

Key Takeaways:

  • The study found that administration of THALOMID(TM)(thalidomide) in patients with AIDS-associated weight loss (cachexia) for up to six months resulted in statistically significant increases in body weight.
  • Significant weight gain was seen at every four-week interval in the study, with a mean weight gain of 13.6 pounds (10 percent) over 28 weeks.
  • Approximately half of the patients (14/30) who received the treatment returned to their pre-morbid weight.
  • Weight gain continued through 68 weeks of therapy, although the number of patients participating in the study declined beyond the 28th week of treatment.
  • Patients who started treatment at 100 mg/day experienced the most pronounced weight gain.
  • The most common side effects that led to discontinuation of the study included peripheral neuritis, leukopenia, and neuropathy.

Statistics:

  • Mean weight gain: 13.6 pounds (10 percent) over 28 weeks
  • Mean CD-4 T-cell count: 92 (safety group), 96 (intention to treat group)
  • Initial THALOMID(TM)(thalidomide) dosages: 50 mg/day, 100 mg/day, or 200 mg/day
  • Mean exposure to THALOMID(TM)(thalidomide): 149 days (range: 8-661 days)

Sources:

  • Celgene Corporation (PRNewswire, July 27, 1998)
  • 12th Annual World AIDS Conference in Geneva (presented by Celgene Corporation)

Read more