Pirfenidone treatment for patients with atypical liver function
AssigneeIntermune, Inc.
InventorsWilliamson Z. Bradford, Javier Szwarcberg
Life of this patent
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Abstract
Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
Claims56
A method of administering pirfenidone to treat a patient who would benefit from pirfenidone administration, optionally a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited a Grade 2 abnormality in one or more biomarkers of liver function after pirfenidone administration, comprising (a) administering to said patient pirfenidone at doses of at least 1600 mg/day or 1602 mg/day.
Pirfenidone for use in treating a patient who would benefit from pirfenidone administration, optionally a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited a Grade 2 abnormality in one or more biomarkers of liver function after pirfenidone administration, wherein (a) said patient is administered pirfenidone at doses of 2400 mg/day or 2403 mg/day.
Use of pirfenidone in the manufacture of a medicament for treating a patient who would benefit from pirfenidone administration, optionally a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited a Grade 2 abnormality in one or more biomarkers of liver function after pirfenidone administration, wherein (a) said patient is administered pirfenidone at doses of 2400 mg/day or 2403 mg/day.
Pirfenidone for use in treating a patient who would benefit from pirfenidone administration, optionally a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited a Grade 2 abnormality in one or more biomarkers of liver function after pirfenidone administration, wherein (a) said patient is administered pirfenidone at doses of at least 1600 mg/day or 1602 mg/day.
Use of pirfenidone in the manufacture of a medicament for treating a patient who would benefit from pirfenidone administration, optionally a patient with idiopathic pulmonary fibrosis (IPF), said patient having exhibited a Grade 2 abnormality in one or more biomarkers of liver function after pirfenidone administration, wherein (a) said patient is administered pirfenidone at doses of at least 1600 mg/day or 1602 mg/day.
The method or use of any of the preceding claims, wherein the patient who would benefit from pirfenidone administration suffers from a condition selected from the group consisting of pulmonary fibrosis, idiopathic interstitial pneumonia, autoimmune lung diseases, benign prostate hypertrophy, coronary or myocardial infarction, atrial fibrillation, cerebral infarction, myocardiac fibrosis, musculoskeletal fibrosis, post-surgical adhesions, liver cirrhosis, renal fibrotic disease, fibrotic vascular disease, scleroderma, Hermansky-Pudlak syndrome, neurofibromatosis, Alzheimer's disease, diabetic retinopathy, skin lesions, and lymph node fibrosis associated with HIV.
The method or use of any of the preceding claims wherein the patient who would benefit from pirfenidone administration suffers from a condition selected from the group consisting of chronic obstructive pulmonary disease (COPD), inflammatory pulmonary fibrosis (IPF), rheumatoid arthritis, rheumatoid spondylitis, osteoarthritis, gout, sepsis, septic shock, endotoxic shock, gram-negative sepsis, toxic shock syndrome, myofacial pain syndrome (MPS), Shigellosis, asthma, adult respiratory distress syndrome, inflammatory bowel disease, Crohn's disease, psoriasis, eczema, ulcerative colitis, glomerular nephritis, scleroderma, chronic thyroiditis, Grave's disease, Ormond's disease, autoimmune gastritis, myasthenia gravis, autoimmune hemolytic anemia, autoimmune neutropenia, thrombocytopenia, pancreatic fibrosis, chronic active hepatitis, acute and chronic renal disease, renal fibrosis, irritable bowel syndrome, pyresis, restenosis, cerebral malaria, stroke and ischemic injury, neural trauma, Huntington's disease, Parkinson's disease, acute and chronic pain, allergies, cardiac hypertrophy, chronic heart failure, acute coronary syndrome, cachexia, malaria, leprosy, leishmaniasis, Lyme disease, Reiter's syndrome, acute synoviitis, muscle degeneration, bursitis;
- tendonitis, tenosynoviitis, herniated, ruptured, or prolapsed intervertebral disk syndrome, osteopetrosis, thrombosis, silicosis, pulmonary sarcosis, bone resorption diseases, cancer, graft-versus-host reaction;
- and auto-immune diseases, AIDS, Herpes Zoster, Herpes Simplex I or II, influenza virus, Severe Acute Respiratory Syndrome (SARS), cytomegalovirus, and diabetes mellitus.
Dependencies are inferred from the claim text.