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Idiopathic Pulmonary Fibrosis

Jeremy Feldman, MD

  • What is Idiopathic Pulmonary Fibrosis?
    • Idiopathic Pulmonary Fibrosis Definition
    • Symptoms of Idiopathic Pulmonary Fibrosis
    • Causes of Idiopathic Pulmonary Fibrosis
    • Who Gets Idiopathic Pulmonary Fibrosis
    • Gastro-Esophageal Reflux (GER) and Idiopathic Pulmonary Fibrosis
    • Interstitial Lung Disease vs. Idiopathic Pulmonary Fibrosis
    • Is Pulmonary Fibrosis Hereditary?
    • Research, Life Expectancy and Prognosis for Idiopathic Pulmonary Fibrosis
  • Diagnosing & Monitoring PF
    • Monitoring Progress of IPF
    • Idiopathic Pulmonary Fibrosis Diagnosis
    • Chest X-rays Used in IPF
    • CPET used in IPF
    • HRCT Scans Used to Evaluate IPF
    • Lung Biopsy To Diagnose IPF
    • Pulmonary Function Tests (PFTS)
    • Six Minute Walk Test To Monitor IPF
    • Stages of Idiopathic Pulmonary Fibrosis
    • Complications of Idiopathic Pulmonary Fibrosis
  • PF Treatment Options
    • Esbriet (pirfenidone) Used to Treat IPF
    • OFEV (nintedanib) Used to Treat IPF
    • Pulmonary Rehab for IPF Patients
    • Lung Transplantation for Pulmonary Fibrosis
    • Oxygen Used to Treat IPF
      • Update on Oxygen Use
    • Clinical Trials in Idiopathic Pulmonary Fibrosis
    • IPF & Leg Swelling
    • Pulmonary Hypertension and Idiopathic Pulmonary Fibrosis
    • IPF Exacerbation
  • PF Advocacy & News
  • FAQ’s
    • Respiratory failure, NSIP, diet
    • Leg swelling, lung biopsy, side effects & pets
    • FAQ’s Enzyme Therapy, Progression of IPF & Oxygen
    • FAQ: Diarrhea, Fibrosis Reversal, IPF Symptoms
    • FAQ: Oxygen Flow, Anesthesia & Genetics
    • FAQ: Contagious Cough? Stem Cells, Familial IPF, Flying
    • FAQ: GERD, Fatigue & Environmental Exposure
    • FAQ: How to Travel to Your Doctor’s Office with Oxygen
    • FAQ: Lung Biopsy with Pulmonary Fibrosis
    • FAQ’s: Alcohol, Clinical Trials, Pulmonary Function Testing
    • FAQs: Emphysema, Exercise & Lung Biopsy

Don’t Be Discouraged

February 29, 2016 By Dr. Jeremy Feldman

Phase 2 Study for Simtuzumab as IPF Treatment Stopped

UpdateGilead 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 need to remember that the road to successful development of a new drug for IPF is very challenging.  For more than three decades we only had negative studies.

Why are Drug Trials Stopped Midway Through?

There are three major reasons that drug trials are stopped.  Built into the clinical trial are periodic pauses when the DSMB–data safety and monitoring board (a group of doctors, scientists and statisticians) evaluate the data gathered.  This board is responsible for ensuring that the drug being developed is not hurting patients.

If the DSMB identifies a major safety concern, the study is stopped immediately.  This happens on occasion.  We are never able to know all of the risks of new molecules prior to conducting research trials.  In addition to being vigilant for safety issues, the DSMB is also evaluating the drugs efficacy at various times.  If a drug is halfway through the study and the data being collected shows that the drug is not effective, then the study may be stopped for what is called futility (lack of any prospects for a positive study).  Lastly, some times the DSMB stops a trial midway through because the medicine under study is so effective that it is not ethical to continue to have half the study participants continue on placebo (sugar pill).  To summarize, the DSMB may stop a study for safety, futility or overwhelming evidence of efficacy.

Gilead should be congratulated for investing heavily in IPF research and we hope that they will continue their quest for a new effective therapy for this difficult disease.  To the many patients that participated in the RAINIER study, the IPF community is grateful for your contribution.  Don’t be discouraged.  Over the years, many of my patients have participated in numerous different clinical trials.  For IPF, until we discover a cure, our best hope of moving care forward is through the generous efforts of our patients who continue to participate in research studies.

Filed Under: IPF Treatment

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Idiopathic Pulmonary Fibrosis Treatment Options

What is IPF?

  • What is Idiopathic Pulmonary Fibrosis?
    • Symptoms of Idiopathic Pulmonary Fibrosis
    • Causes of Idiopathic Pulmonary Fibrosis
    • Who Gets Idiopathic Pulmonary Fibrosis
    • Gastro-Esophageal Reflux (GER) and IPF
    • Interstitial Lung Disease vs. Idiopathic Pulmonary Fibrosis
    • Is Pulmonary Fibrosis Hereditary?
    • Research, Life Expectancy & Prognosis for Pulmonary Fibrosis

Diagnosing IPF

  • Idiopathic Pulmonary Fibrosis Diagnosis
    • Chest X-rays Used in IPF
    • CPET used in IPF
    • HRCT Scans Used to Evaluate IPF
    • Lung Biopsy To Diagnose IPF
    • Pulmonary Function Tests (PFTS)
    • Six Minute Walk Test To Monitor IPF
    • Stages of Idiopathic Pulmonary Fibrosis
    • Complications of Idiopathic Pulmonary Fibrosis

Treating IPF

  • Pulmonary Fibrosis Treatment Options
    • Esbriet (pirfenidone) Used to Treat IPF
    • OFEV (nintedanib) Used to Treat IPF
    • Pulmonary Rehab for IPF Patients
    • Lung Transplantation for Pulmonary Fibrosis
    • Oxygen Used to Treat IPF
    • Clinical Trials in Idiopathic Pulmonary Fibrosis
    • IPF & Leg Swelling
    • Pulmonary Hypertension and Idiopathic Pulmonary Fibrosis
    • IPF Exacerbation

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