Safe and effective method of treating psoriasis with anti-IL-23 specific antibody
A method of treating psoriasis in a patient by administering an IL-23 specific antibody, e.g., guselkumab, in a clinically proven safe and clinically proven effective amount and the patient achieves PASI90, PASI100 or IGA 0 or 1 score as measured 16, 24, 32, 40 and 48 weeks after initial treatment and the patient achieves higher efficacy than a patient treated with the secukinumab antibody.
1. A method of treating psoriasis in a patient previously treated with at least one dose of secukinumab, comprising discontinuing secukinumab treatment to the patient; and administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, wherein the antibody to IL-23 comprises a light chain variable region and a heavy chain variable region, said light chain variable region comprising:
a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:50;
a CDRL2 amino acid sequence of SEQ ID NO:56; and
a CDRL3 amino acid sequence of SEQ ID NO:73,
said heavy chain variable region comprising:
a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:5;
a CDRH2 amino acid sequence of SEQ ID NO:20; and
a CDRH3 amino acid sequence of SEQ ID NO:44.
2. The method of claim 1 , wherein the patient is treated with the antibody to IL-23 for at least 44 weeks to demonstrate efficacy in a psoriasis clinical endpoint selected from the group consisting of PASI90, PASI100, IGA 0 and IGA 1.
3. The method of claim 2 , wherein the psoriasis clinical endpoint is measured 44 and/or 48 weeks after initial treatment with the antibody to IL-23.
4. The method of claim 3 , wherein the psoriasis clinical endpoint is measured 48 weeks after initial treatment with the antibody to IL-23.
5. The method of claim 1 , wherein the antibody to IL-23 is administered in an initial dose, 4 weeks after the initial dose and every 8 weeks after the dose at 4 weeks.
6. The method of claim 1 , wherein the secukinumab antibody was administered in an initial dose, 1 week after the initial dose, 2 weeks after the initial dose, 3 weeks after the initial dose, 4 weeks after the initial dose and every 4 weeks after the dose at 4 weeks.
7. The method of claim 1 , wherein the antibody to IL-23 is administered at a dose of 100 mg.
8. The method of claim 7 , wherein the antibody to IL-23 is in a composition comprising 100 mg/mL of antibody; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state.
9. The method of claim 1 , wherein the antibody to IL-23 is safe and effective treating psoriasis at an area of a patient selected from the group consisting of scalp, nails, hands and feet.
10. The method of claim 1 , further comprising administering to the patient one or more additional drugs used to treat psoriasis.
11. The method of claim 10 , wherein the additional drug is selected from the group consisting of: immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers.
12. The method of claim 1 , wherein the antibody to IL-23 is effective to reduce a symptom of psoriasis in the patient, induce clinical response, induce or maintain clinical remission, inhibit disease progression, or inhibit a disease complication in the patient.
13. The method of claim 1 , wherein the patient is treated for moderate to severe psoriasis.
14. The method of claim 1 , further comprising the step of measuring the psoriasis clinical endpoint PASI90, PASI100, IGA 0 and/or IGA 1 at 44 and/or 48 weeks after initial treatment and discontinuing treatment of a patient previously treated with at least one dose of secukinumab and treating the patient with guselkumab.
15. The method of claim 1 , wherein the patient has psoriatic arthritis.
16. A method of treating psoriasis in a patient previously treated with at least one dose of secukinumab, comprising discontinuing secukinumab treatment to the patient; and administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, the antibody to IL-23 comprising a light chain variable region of the amino acid sequence of SEQ ID NO: 116 and a heavy chain variable region of the amino acid sequence of SEQ ID NO: 106.
17. The method of claim 16 , wherein the patient is treated with the antibody to IL-23 for at least 44 weeks to demonstrate efficacy in a psoriasis clinical endpoint selected from the group consisting of PASI90, PASI100, IGA 0 and IGA 1.
18. The method of claim 17 , wherein the psoriasis clinical endpoint is measured 44 and/or 48 weeks after initial treatment with the antibody to IL-23.
19. The method of claim 18 , wherein the psoriasis clinical endpoint is measured 48 weeks after initial treatment with the antibody to IL-23.
20. The method of claim 16 , wherein the antibody to IL-23 is administered in an initial dose, 4 weeks after the initial dose and every 8 weeks after the dose at 4 weeks.
21. The method of claim 16 , wherein the secukinumab antibody was administered in an initial dose, 1 week after the initial dose, 2 weeks after the initial dose, 3 weeks after the initial dose, 4 weeks after the initial dose and every 4 weeks after the dose at 4 weeks.
22. The method of claim 16 , wherein the antibody to IL-23 is administered at a dose of 100 mg.
23. The method of claim 22 , wherein the antibody to IL-23 is in a composition comprising 100 mg/mL of antibody; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state.
24. The method of claim 16 , wherein the antibody to IL-23 is safe and effective treating psoriasis at an area of a patient selected from the group consisting of scalp, nails, hands and feet.
25. The method of claim 16 , further comprising administering to the patient one or more additional drugs used to treat psoriasis.
26. The method of claim 25 , wherein the additional drug is selected from the group consisting of: immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers.
27. The method of claim 16 , wherein the antibody to IL-23 is effective to reduce a symptom of psoriasis in the patient, induce clinical response, induce or maintain clinical remission, inhibit disease progression, or inhibit a disease complication in the patient.
28. The method of claim 16 , wherein the patient is treated for moderate to severe psoriasis.
29. The method of claim 16 , further comprising the step of measuring the psoriasis clinical endpoint PASI90, PASI100, IGA 0 and/or IGA 1 at 44 and/or 48 weeks after initial treatment and discontinuing treatment of a patient previously treated with at least one dose of secukinumab and treating the patient with guselkumab.
30. The method of claim 16 , wherein the patient has psoriatic arthritis.
31. A method of treating moderate-to-severe plaque psoriasis in an adult patient who is a candidate for systemic therapy or phototherapy and who has previously been treated with at least one dose of secukinumab, comprising discontinuing secukinumab treatment to the patient; and administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, wherein the antibody comprises a light chain variable region of the amino acid sequence of SEQ ID NO: 116 and a heavy chain variable region of the amino acid sequence of SEQ ID NO: 106, the dosage is 100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter and the antibody is at a concentration of 100 mg/mL in a single-dose prefilled syringe comprising 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 and the diluent is water at standard state.