Granted Patent B2

US 12,655,206 · App. 17/691,219 · Granted Jun 16, 2026

Inventors: Elizabeth Hsia (Kennett Square, PA); Chetan Karyekar (Horsham, PA); Alexa Kollmeier (San Diego, CA); Wim Noel (Flemish Brabant, BE); Jaime Oliver Vigueras (Zug, CH); Agata Schubert-Wlodarczyk (Warsaw, PL); May Shawi (Horsham, PA); Virginia Taliadouros (Leiden, NL); Xie Xu (San Diego, CA)

Assignee: Janssen Biotech, Inc.

C07K16/244A61P19/02A61P37/06C07K16/241A61K2039/505A61K2039/545C07K2317/76

Abstract

Claims (34)

1 . A method of treating psoriatic arthritis in a subject in need thereof, wherein the subject showed an inadequate response to treatment with an anti-TNFα biologic therapy, wherein the anti-TNFα biologic therapy is an anti-TNFα antibody or TNFα non-antibody antagonist, wherein the anti-TNFα antibody is adalimumab, golimumab, certolizumab pegol therapy, infliximab and/or biosimilars thereto and the TNFα non-antibody antagonist is etanercept and/or biosimilars thereto, the method comprising subcutaneously administering to the subject 50 mg to 150 mg of an anti-IL-23 antibody once every 4 weeks (q4w), wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO: 1, a CDRH2 of SEQ ID NO: 2, and a CDRH3 of SEQ ID NO: 3; and the light chain variable region comprising a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO: 4, a CDRL2 of SEQ ID NO: 5, and a CDRL3 of SEQ ID NO: 6, and wherein the subject achieves an improvement in a disease activity determined by at least one criteria selected from the group consisting of a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28)C-reactive protein (CRP), resolution of enthesitis, resolution of dactylitis, Leeds enthesitis index (LEI), dactylitis assessment score, Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), GRAppa Composite score (GRACE), Psoriatic ArthritiS Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), and Patient-Reported Outcomes Measurement Information System-29 PROMIS-29).

2 . The method of claim 1 , wherein the antibody comprises the heavy chain variable region of the amino acid sequence of SEQ ID NO: 7, and the light chain variable region of the amino acid sequence of SEQ ID NO: 8.

3 . The method of claim 1 , wherein the antibody comprises the heavy chain amino acid sequence of SEQ ID NO: 9, and the light chain amino acid sequence of SEQ ID NO: 10.

4 . The method of claim 1 , wherein the antibody is administered at a dose of 100 mg per administration.

5 . The method of claim 1 , wherein achieving the improvement in disease activity ACR20 occurs following a treatment period of 24 weeks.

6 . The method of claim 5 , wherein the method further comprises maintaining the improvement in disease activity ACR20 from 24 weeks following a treatment period of 48 weeks.

7 . The method of claim 1 , wherein the method further comprises the subject achieving at least a 20% improvement in the American College of Rheumatology core set index (ACR20).

8 . The method of claim 1 , wherein the method further comprises the subject achieving at least a 50% improvement in the American College of Rheumatology core set disease index (ACR50) after the treatment.

9 . The method of claim 1 , wherein the method further comprises the subject achieving an improvement in a Health Assessment Questionnaire Disability Index (HAQ-DI) following a treatment period of at least 24 weeks or 48 weeks.

10 . The method of claim 1 , wherein the method further comprises the subject achieving an improvement in Disease Activity Score 28 (DAS28)C-reactive protein (CRP) following a treatment period of at least 24 weeks or 48 weeks.

11 . The method of claim 1 , wherein the method further comprises the subject achieving an Investigator's Global Assessment (IGA) of 0 (clear) or 1 (minimal), or 2 or more grade reduction in the IGA, following a treatment period of at least 24 weeks or at least 48 weeks, wherein the subject has 3% or more body surface area (BSA) psoriatic involvement and an IGA score of 2 or more at the baseline before the treatment.

12 . The method of claim 1 , wherein the subject has had inadequate response to a standard therapy for the PsA, optionally, the subject is also administered the standard therapy during the treatment.

13 . A method of treating psoriatic arthritis in a subject in need thereof, wherein the subject showed an inadequate response to treatment with an anti-TNFα biologic therapy, wherein the anti-TNFα biologic therapy is an anti-TNFα antibody or TNFα non-antibody antagonist, wherein the anti-TNFα antibody is adalimumab, golimumab, certolizumab pegol therapy, infliximab and/or biosimilars thereto and the TNFα non-antibody antagonist is etanercept and/or biosimilars thereto, the method comprising subcutaneously administering to the subject 50 mg to 150 mg of an anti-IL-23 antibody once at week 0, once at week 4, and once every 8 weeks (q8w) thereafter, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO: 1, a CDRH2 of SEQ ID NO: 2, and a CDRH3 of SEQ ID NO: 3; and the light chain variable region comprising a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO: 4, a CDRL2 of SEQ ID NO: 5, and a CDRL3 of SEQ ID NO: 6, and wherein the subject has at least one psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis before the treatment, and wherein the subject achieves an improvement in a disease activity determined by at least one criteria selected from the group consisting of a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28)C-reactive protein (CRP), resolution of enthesitis, resolution of dactylitis, Leeds enthesitis index (LEI), dactylitis assessment score, Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), GRAppa Composite score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)).

14 . The method of claim 13 , wherein the antibody comprises the heavy chain variable region of the amino acid sequence of SEQ ID NO: 7, and the light chain variable region of the amino acid sequence of SEQ ID NO: 8.

15 . The method of claim 14 , wherein the antibody comprises the heavy chain amino acid sequence of SEQ ID NO: 9, and the light chain amino acid sequence of SEQ ID NO: 10.

16 . The method of claim 13 , wherein the antibody is administered at a dose of 100 mg per administration.

17 . The method of claim 13 , wherein achieving the improvement in disease activity occurs following a treatment period of 24 weeks or 48 weeks.

18 . The method of claim 13 , wherein the method further comprises the subject achieving at least a 20% improvement in the American College of Rheumatology core set disease index (ACR20).

19 . The method of claim 13 , wherein the method further comprises the subject achieving at least a 50% improvement in the American College of Rheumatology core set disease index (ACR50) after the treatment.

20 . The method of claim 13 , wherein the method further comprises the subject achieving an improvement in a Health Assessment Questionnaire Disability Index (HAQ-DI) following a treatment period of at least 24 weeks or 48 weeks.

21 . The method of claim 13 , wherein the method further comprises the subject achieving an improvement in Disease Activity Score 28 (DAS28)C-reactive protein (CRP) following a treatment period of at least 24 weeks or at least 48 weeks.

22 . The method of claim 13 , wherein the method further comprises the subject achieving an Investigator's Global Assessment (IGA) of 0 (clear) or 1 (minimal), or 2 or more grade reduction in the IGA, following a treatment period of at least 24 weeks, wherein the subject has 3% or more body surface area (BSA) psoriatic involvement and an IGA score of 2 or more at the baseline before the treatment.

23 . The method of claim 1 , wherein the subject has had inadequate response to a standard therapy for the PsA.

24 . The method of claim 23 , wherein the subject is also administered with the standard therapy during the treatment.

25 . A method of treating psoriatic arthritis in a subject in need thereof, wherein the subject showed an inadequate response to treatment with an anti-TNFα biologic therapy, wherein the anti-TNFα biologic therapy is an anti-TNFα antibody or TNFα non-antibody antagonist, wherein the anti-TNFα antibody is adalimumab, golimumab, certolizumab pegol therapy, infliximab and/or biosimilars thereto and the TNFα non-antibody antagonist is etanercept and/or biosimilars thereto, the method comprising subcutaneously administering to the subject 100 mg of an anti-IL-23 antibody once at week 0, once at week 4, and every 8 weeks (q8w) thereafter, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a complementarity determining region heavy chain 1(CDRH1) amino acid sequence of SEQ ID NO: 1, a CDRH2 of SEQ ID NO: 2, and a CDRH3 of SEQ ID NO: 3; and the light chain variable region comprising a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO: 4, a CDRL2 of SEQ ID NO: 5,and a CDRL3 of SEQ ID NO: 6, and wherein the subject achieves an improvement in a disease activity determined by at least one criteria selected from the group consisting of a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), resolution of enthesitis, resolution of dactylitis, Leeds enthesitis index (LEI), dactylitis assessment score, Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), GRAppa Composite score (GRACE), Psoriatic ArthritiS Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29).

26 . The method of claim 25 , wherein the antibody comprises the heavy chain variable region of the amino acid sequence of SEQ ID NO: 7, and the light chain variable region of the amino acid sequence of SEQ ID NO: 8.

27 . The method of claim 25 , wherein the antibody comprises the heavy chain amino acid sequence of SEQ ID NO: 9, and the light chain amino acid sequence of SEQ ID NO: 10.

28 . The method of claim 25 , wherein achieving the improvement in disease activity occurs following a treatment period of 24 weeks.

29 . The method of claim 28 , wherein the method further comprises maintaining the improvement in disease activity from 24 weeks following a treatment period of 48 weeks.

30 . The method of claim 27 , wherein achieving the improvement in disease activity occurs following a treatment period of 24 weeks.

31 . The method of claim 30 , wherein the method further comprises maintaining the improvement in disease activity from 24 weeks following a treatment period of 48 weeks.

32 . The method of claim 3 , wherein the antibody is administered at a dose of 100 mg per administration.

33 . The method of claim 3 , wherein achieving the improvement in disease activity occurs following a treatment period of 24 weeks.

34 . The method of claim 33 , wherein the method further comprises maintaining the improvement in disease activity from 24 weeks following a treatment period of 48 weeks.

Assignments (13)

Continuity (3)

References Cited (383)