Treatment of pemphigus
The present disclosure provides methods of treating with a BTK inhibitor a blistering disease, in particular pemphigus vulgaris or pemphigus folliaceous in a mammal, use of a BTK inhibitor as a replacement therapy for corticosteroid therapy for diseases treatable with a corticosteroid, such as autoimmune or inflammatory disease and in particular where corticosteroids are used as first or second line therapy, and pharmaceutical formulations comprising the same.
1. A method of treating pemphigus vulgaris or pemphigus foliaceus in a human in need thereof, said method comprising
administering to said human a therapeutically effective amount of a BTK inhibitor (R,E)-2-(3-(4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]-pyrimidin-1-yl)piperidine-1-carbonyl)-4,4-dimethylpent-2-enenitrile.
2. The method of claim 1 , wherein said BTK inhibitor is used in place of a corticosteroid therapy.
3. The method of claim 1 , wherein said BTK inhibitor is used in combination with a corticosteroid therapy.
4. The method of claim 1 , further comprising administering said BTK inhibitor in combination with a noncorticosteroidal immunosupressive and/or anti-inflammatory agent.
5. The method of claim 1 , wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from anti-CD20 antibody, anti-TNF antibody, anti-IL6 agent, anti-IL17 agent, and abatacept.
6. The method of claim 4 , wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from rituximab, tositumomab, veltuzumab, obinutuzumab, Enbrel, and ofatumumab, or a biosimilar version thereof.
7. A method of eliminating or reducing a therapeutic dose of a corticosteroid therapy used in the treatment of pemphigus vulgaris or pemphigus foliaceus in a human in need thereof, wherein said corticosteroid therapy is used as the first or second line in chronic maintenance therapy, said method comprising
administering to said human a therapeutically effective amount of a BTK inhibitor (R,E)-2-(3-(4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]-pyrimidin-1-yl)piperidine-1-carbonyl)-4,4-dimethylpent-2-enenitrile.
8. The method of claim 7 , wherein said BTK inhibitor is used in place of said corticosteroid therapy.
9. The method of claim 7 , wherein said BTK inhibitor is used in combination with said corticosteroid therapy.
10. The method of claim 7 , further comprising administering said BTK inhibitor in combination with a noncorticosteroidal immunosupressive and/or anti-inflammatory agent.
11. The method of claim 10 , wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from anti-CD20 antibody, anti-TNF antibody, anti-IL6 agent, anti-IL17 agent, and abatacept.
12. The method of claim 10 , wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from rituximab, tositumomab, veltuzumab, obinutuzumab, Enbrel, and ofatumumab, or a biosimilar version thereof.
13. A method of treating acute flares of pemphigus vulgaris or pemphigus foliaceous in a human in need thereof, wherein a corticosteroid therapy is used as the first or second line in chronic maintenance therapy, comprising
administering to said human a therapeutically effective amount of a BTK inhibitor (R,E)-2-(3-(4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]-pyrimidin-1-yl)piperidine-1-carbonyl)-4,4-dimethylpent-2-enenitrile.
14. The method of claim 13 , wherein said BTK inhibitor is used in place of said corticosteroid therapy.
15. The method of claim 13 , wherein said BTK inhibitor is used in combination with said corticosteroid therapy.
16. The method of claim 13 , further comprising administering said BTK inhibitor in combination with a noncorticosteroidal immunosupressive and/or anti-inflammatory agent.
17. The method of claim 16 , wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from anti-CD20 antibody, anti-TNF antibody, anti-IL6 agent, anti-IL17 agent, and abatacept.
18. The method of claim 16 , wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from rituximab, tositumomab, veltuzumab, obinutuzumab, Enbrel, and ofatumumab, or a biosimilar version thereof.