Patent application EP16305253A (EP), filed 2016-03-07
Publication number: EP3216461A1
Title: COMPOSITIONS AND METHODS FOR TREATING RHEUMATOID ARTHRITIS
Abstract: The present invention relates to the use of an anti-IL6 receptor antibody in monotherapy for treating rheumatoid arthritis and for improving the physical function and the quality of life of a subject suffering from rheumatoid arthritis.
IPC codes: A61K  39/    00            A I
A61K  39/   395            A I
C07K  16/    28            A I
Claims: number: 1
text: An antibody for use in a method of improving the physical function of a subject suffering from rheumatoid arthritis, wherein:
number: 2
text: The antibody for use according to Claim 1, wherein the subject achieves after at least 24 weeks of administration of the antibody a change from baseline (BL) in the Health Assessment Questionnaire Disability Index (HAQ-DI) of at least 0.22, particularly of at least 0.30, more particularly of at least 0.60.
number: 3
text: An antibody for use in a method of improving the health related quality of life of a subject suffering from rheumatoid arthritis, wherein:
number: 4
text: The antibody for use according to Claim 3, wherein the subject achieves after at least 24 weeks of administration of the antibody a change from baseline (BL) in the Short Form-36 Physical Component Summary (SF-36 PCS) of at least 2.5, particularly of at least 3, more particularly of at least 8.
number: 5
text: An antibody for use in a method of treating rheumatoid arthritis in a subject, wherein:
number: 6
text: The antibody for use according to Claim 5, wherein the subject achieves after at least 24 weeks of administration of the antibody a 20% improvement in the American College of Rheumatology core set disease index (ACR20), particularly a 50% improvement in the American College of Rheumatology core set disease index (ACR50), more particularly a 70% improvement in the American College of Rheumatology core set disease index (ACR70).
number: 7
text: The antibody for use according to any one of Claims 5-6, wherein the subject achieves after at least 24 weeks of administration of the antibody a change from baseline (BL) in the Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) of at least 2, particularly of at least 2.5, more particularly of at least 3.
number: 8
text: The antibody for use according to any one of Claims 5-7, wherein the subject achieves after at least 24 weeks of administration of the antibody a DAS28-ESR score below 3.2, particularly below 2.6.
number: 9
text: The antibody for use according to any one of Claims 1-8, wherein the subject who was previously ineffectively treated for rheumatoid arthritis by administering at least one DMARD different from the antibody, is a subject who was previously ineffectively treated for rheumatoid arthritis by administering Methotrexate.
number: 10
text: The antibody for use according to any one Claims 1-9, wherein the subject suffering from rheumatoid arthritis is a subject suffering from moderately to severely active rheumatoid arthritis.
number: 11
text: The antibody for use according to any one of Claims 1-10, wherein the antibody is administered with a prefilled syringe or with an auto-injector.
number: 12
text: The antibody for use according to any one of Claims 1-11, wherein the antibody is administered as an aqueous buffered solution at pH 6.0 containing 21 mM histidine, 45 mM arginine, 0.2% (w/v) polysorbate 20, 5% (w/v) sucrose.
number: 13
text: The antibody for use according to Claim 12, wherein the solution comprises at least 130 mg/mL of the antibody, particularly the solution comprises 131.6 mg/mL of the antibody.
number: 14
text: The antibody for use according to Claim 12, wherein the solution comprises 175 mg/mL of the antibody.
number: 15
text: The antibody for use according to any one of Claims 1-14, wherein the antibody comprising the heavy chain variable region of sequence SEQ ID NO:1 and the light chain variable region of sequence SEQ ID NO:2 is sarilumab.
Office action: search_report, dated 2017-09-13
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: WO2007143168A2
ref_type: patent
severity: background
ref_id: WO2011085158A2
ref_type: patent
severity: background
ref_id: - BRITISH JOURNAL OF RHEUMATOLOGY, vol. 36, 1997, pages 884 - 888
ref_type: npl
severity: background
ref_id: WO2013053751A1
ref_type: patent
severity: background
ref_id: WO2015077582A1
ref_type: patent
severity: background
ref_id: US2008131374A1
ref_type: patent
severity: background
ref_id: WO2013053751
ref_type: patent
severity: novelty_destroying
ref_id: WO2015077582
ref_type: patent
severity: background
ref_id: US2008131374
ref_type: patent
severity: background
Final disposition: pending (2017-09-13)