Combining cancer drug, budesonide does not reduce side effects, study concludes
PHILADELPHIA Patients with stage 3 or 4 melanoma taking ipilimumab (a human monoclonal antibody being developed by Bristol-Myers Squibb and Medarex) and the oral steroid budesonide to reduce side effects did not have less diarrhea, a known side effect of ipilimumab, according to results of a phase 2 trial published in Clinical Cancer Research, a journal of the American Association for Cancer Research.
These findings would “discourage the prophylactic use of budesonide to reduce the gastrointestinal side effects of ipilimumab,” stated researcher Jeffrey Weber, a senior member at the Moffitt Cancer Center and director of the Donald A. Adam Comprehensive Melanoma Research Center in Tampa, Fla.
Weber and colleagues gave 10 mg/kg of ipilimumab to 115 patients every three weeks, for four doses. This was combined with daily budesonide for one group and placebo control for another.
After four months of treatment, they found that budesonide did not affect the rate of diarrhea – it occurred in 32.7% of patients treated with the drug and 35% of those who received placebo, according to the study. Median overall survival was 17.7 months among those treated with budesonide compared with 19.3 months among those who received placebo.
Additionally, the researchers saw anti-tumor responses in 10% to 15% of patients, without an apparent difference between patients treated with budesonide and those who received placebo.
“This study attempted to decrease the side effects of ipilimumab by using a preventative enteric steroid regimen. This approach failed to accomplish that goal,” said Jennifer Grandis, editorial board member for Clinical Cancer Research. “The study supports the contention that ipilimumab has use as a treatment in this disease, but more research is needed to elaborate on these findings and unveil ways to manage and potentially reduce side effects associated with this drug’s use,” she said.
Weber said he was not surprised by the favorable clinical results of this study and agreed that ipilimumab should be pursued in further clinical trials.
“Ipilimumab appears to result in prolonged median and overall survivals in patients with stage IV melanoma,” he said. “A significant proportion of patients receiving ipilimumab may have long-term survival.”
Ipilimumab (also known as MDX-010 or MDX-101) is in a class of drugs called monoclonal antibodies, which stimulate the body’s own immune system to fight disease. It is currently in clinical trials for the treatment of melanoma. Budesonide is currently used for the treatment of inflammatory bowel disease, asthma, non-infectious rhinitis and for the treatment and prevention of growths in the nasal cavity.
Diplomat, Commcare named top companies by Inc. magazine
NEW YORK Specialty pharmacies Commcare Pharmacy and Diplomat Specialty Pharmacy have earned the respective 235th and 374th places on Inc. magazine’s list of the 500 fastest-growing private companies in the United States.
This goes to show how rapidly the specialty pharmacy industry has grown thanks to its focus on complex illnesses and medication regimens that traditional pharmacies are mostly unable to support, growing 8.8% last year, compared to 4.4% for traditional pharmacies, while specialty drugs had nearly $60 billion in U.S. sales.
But specialty pharmacy can also give independent pharmacies without a large front end a good way to make money, with its emphasis on profitable biotech drugs and closer interaction between the patient and pharmacist, allowing the mom-and-pop street corner pharmacy to carve a niche for itself while the chain pharmacy down the road continues to serve traditional drug store functions.
CVS Caremark study finds need for improvements in healthcare access, costs
NEW YORK CVS Caremark’s 2009 “Health IQ” study is yet another indicator coming from the private sector that health reform cannot wait.
The findings come on the heels of another sign: PhRMA’s resurrection of the Harry and Louise characters, the middle class couple who helped to defeat the Clinton healthcare reform proposal, in a new multi-million dollar ad campaign developed in collaboration with Families USA, the national organization for healthcare consumers. This time, however, Harry and Louise are in support of healthcare reform.
The reality is that the more the private sector leads the way on this, the more likely that reform will work for them, as well as the rest of America.
For instance, CVS’ MinuteClinic could play a major role in closing the gap on patient access. In addition, CVS’ Proactive Pharmacy Care program, as well as its new ReadyFill program, could help improve medication adherence ‹ another major problem in the U.S. healthcare system. Proactive Pharmacy Care is focused on helping consumers understand the benefits of taking their medication consistently and helps them understand ways to reduce costs. It is estimated that non-adherence costs the United States $177 billion a year.
The bottom line is that there is a sense that if it and other key stakeholders step up now and communicate how they can be a part of the solution — and the value in that — they just might be in the end. It’s the difference between driving health reform and getting run over by health reform. Either way, you get a sense that the key stakeholders know the train is rolling and they would rather drive the engine then lay on the tracks.