Tue-25-10-2011, 11:07 AM
Analyses of data from two large, prospective, phase 3 studies investigating ustekinumab (Stelara, Janssen Biotech) for the treatment of moderate-to-severe plaque psoriasis are consistent in demonstrating the safety and efficacy of restarting the biologic if treatment is temporarily interrupted.
The findings from post-hoc analyses investigating responses to retreatment with ustekinumab were presented in a poster at the 2011 summer meeting of the American Academy of Dermatology. They showed that among patients who initially responded to ustekinumab; withdrew from therapy; and then reinitiated treatment because of relapse, about 85 percent or more recaptured the treatment benefit.
The responses to retreatment in terms of rapidity of onset and magnitude of benefit approached the outcomes with initial therapy, and review of adverse event data showed no difference in the safety profile of ustekinumab comparing 12-week periods of initial treatment and retreatment.
Dr. Lebwohl says the positive efficacy and safety profile of reinitiated ustekinumab contrasts with outcomes of restarting treatment with other biologics. For example, responders to infliximab (Remicade, Janssen Biotech) who stop treatment are likely to develop antibodies to the biologic agent that mitigate future therapeutic response, and they also are at increased risk for developing an infusion reaction.
"Analyses of responses in patients restarting ustekinumab identified negative status for antibodies to the biologic as a potential predictor of response. However, antibody development occurs much less frequently in patients treated with ustekinumab compared with infliximab," Dr. Lebwohl says.
Source: modernmedicine.com
The findings from post-hoc analyses investigating responses to retreatment with ustekinumab were presented in a poster at the 2011 summer meeting of the American Academy of Dermatology. They showed that among patients who initially responded to ustekinumab; withdrew from therapy; and then reinitiated treatment because of relapse, about 85 percent or more recaptured the treatment benefit.
The responses to retreatment in terms of rapidity of onset and magnitude of benefit approached the outcomes with initial therapy, and review of adverse event data showed no difference in the safety profile of ustekinumab comparing 12-week periods of initial treatment and retreatment.
Dr. Lebwohl says the positive efficacy and safety profile of reinitiated ustekinumab contrasts with outcomes of restarting treatment with other biologics. For example, responders to infliximab (Remicade, Janssen Biotech) who stop treatment are likely to develop antibodies to the biologic agent that mitigate future therapeutic response, and they also are at increased risk for developing an infusion reaction.
"Analyses of responses in patients restarting ustekinumab identified negative status for antibodies to the biologic as a potential predictor of response. However, antibody development occurs much less frequently in patients treated with ustekinumab compared with infliximab," Dr. Lebwohl says.
Source: modernmedicine.com