Phase 2 Study for Simtuzumab as IPF Treatment Stopped Gilead Sciences recently announced that their large phase 2 study of Simtuzumab (identified by the acronym RAINIER) was stopped at the mid-term analysis for lack of efficacy.  We were all saddened by the news.  The IPF community was riding high after two successful molecules were approved (Esbriet and OFEV).  However, we … [Read more...]

Until last year, the IPF community had no FDA approved medications to treat Idiopathic Pulmonary Fibrosis.  Today we have two medications (OFEV and Esbriet).  Both probably improve survival by slowing disease progression and decreasing the frequency of dangerous flares of the disease.  Unfortunately, these medications do nothing to decrease some of the most troubling symptoms … [Read more...]

In order for medications to be successful, we often have to overcome substantial side effects.  As we weigh the benefits of a medication against its side effects, we must consider the seriousness of the underlying disease and our options for alternative treatments.  Idiopathic pulmonary fibrosis is a progressive disease that in the absence of treatment progresses to respiratory … [Read more...]

Many medications are accompanied by side effects.  These side effects can range from annoying to life-threatening.  When the FDA considers approving a new medication, there is a careful evaluation of the benefits of the new medication weighed against the side effects.  For life threatening diseases such as pulmonary fibrosis, the FDA is willing to accept substantial side … [Read more...]

Unfortunately, having idiopathic pulmonary fibrosis does not prevent you from developing yet another serious lung problem.  Data from several studies have shown that patients with IPF are at higher (5-7 times greater) risk for lung cancer.  This risk is independent of smoking exposure.  We don’t have a clear explanation for this observation but it does inform our care of IPF … [Read more...]