Use of the il-1beta binding antibody canakinumab for treating or alleviating symptoms of pulmonary sarcoidosis
AssigneeNovartis AG
InventorStephen John OLIVER
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Abstract
The present invention relates to a method for treating or alleviating the symptoms of pulmonary sarcoidosis in a subject, comprising administering about 25 mg to about 300 mg of canakinumab.
Claims63
Method of treating or alleviating the symptoms of pulmonary sarcoidosis in a subject, comprising administering about 25 mg to about 300 mg of canakinumab.
The method according to any of the preceding claims, wherein the subject has predicted forced vital capacity (% FVC) of ≤90% before treatment.
The method according to any of the preceding claims, wherein the subject has predicted forced vital capacity (% FVC) of ≤85% before treatment.
The method according to any of the preceding claims, wherein the subject has predicted forced vital capacity (% FVC) of ≤80%. before treatment.
The method according to any of the preceding claims, wherein the subject has greater than 3% improvement in predicted forced vital capacity (FVC) after at least 24 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein the subject has improved lung function as determined by spirometry after at least 24 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein the subject has improved lung function as determined by plethysmography after at least 24 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein the subject has improved lung function as determined by diffusing capacity of carbon monoxide (DLCO) after at least 24 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein the subject has improved ability for physical activity, determined by the 6 minute walk test (6MWT), of at least one of the following:
- a walk distance-in-6 minutes increase,
- dyspnea-free walk distance increase,
- a maximum walk distance increase,
- after at least 12 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein the subject has improved ability for physical activity, determined by the 6 minute walk test (6MWT), of at least one of the following:
- a walk distance-in-6 minutes increase,
- dyspnea-free walk distance increase,
- a maximum walk distance increase,
- after at least 24 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein the subject has decreased parenchymal abnormalities after at least 24 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein the parenchymal abnormalities are detected by high-resolution computing tomography (HRCT).
The method according to any of the preceding claims, wherein the subject experiences improvements on the MMRC scale of dyspnea of at least 1 point after at least 24 weeks of treatment compared to before treatment.
The method according to any of the preceding claims, wherein canakinumab is administered twice a month, monthly, quarterly, every 2 months, every 3 months, every 4 months, every 5 months or every 6 months or every 2 weeks, every 4 weeks, every 6 weeks, every 8 weeks, every 12 weeks, every 16 weeks, every 20 weeks or every 24 weeks.
The method according to any of the preceding claims, wherein canakinumab is administered monthly.
The method according to any of the preceding claims, wherein canakinumab is administered quarterly.
The method according to any of the preceding claims, wherein said method comprises administering about 25, 50, 75, 80, 100, 125, 150, 175, 200, 225, 250, 275, 300 mg or any combination thereof of canakinumab.
The method according to any of the preceding claims, wherein said method comprises administering about 50 mg of canakinumab.
The method according to any of the preceding claims, wherein said method comprises administering about 80 mg of canakinumab.
The method according to any of the preceding claims, wherein said method comprises:
- administering about 150 mg of canakinumab.
The method according to any of the preceding claims, wherein said method comprises:
- administering about 200 mg of canakinumab.
The method according to any of the preceding claims, wherein said method comprises:
- administering about 300 mg of canakinumab.
The method according to any of the preceding claims, further comprising administering the patient an additional dose of about 25 mg to about 300 mg of canakinumab at week 2, week 4 or week 6 or 2 months or three months or four months or five months or six months from first administration.
The method according to any of the preceding claims, wherein canakinumab is administered subcutaneously.
The method according to any of the preceding claims, wherein canakinumab is administered to the patient in a liquid form or lyophilized form for reconstitution contained in a prefilled syringe.
The method according to any of the preceding claims, wherein the subject is concomitantly receiving a glucocorticoid and/or an immunosuppressive agent such as methotrexate, azathioprine, leflunomide, hydroxychloroquine or mycophenolate.
Canakinumab for use in treating or alleviating the symptoms of pulmonary sarcoidosis in a subject, comprising administering about 25 mg to about 300 mg of canakinumab.
Use of canakinumab for the manufacture of a medicament for treating or alleviating the symptoms of pulmonary sarcoidosis in a subject, comprising administering about 25 mg to about 300 mg of canakinumab.
Dependencies are inferred from the claim text.