METHODS FOR TREATING DIGITALLY-IDENTIFIED IL-4/IL-13 RELATED DISORDERS
Disclosed are methods of treating various disorders with anti-IL-4Rα antibodies and fragments thereof.
1 . A method of treating a lung-related disorder in a subject in need thereof with an anti-interleukin-4 receptor alpha (anti-IL-4Rα) antibody, with the proviso that the lung-related disorder is not asthma or chronic obstructive pulmonary disease, the method comprising administering a therapeutically effective amount of an anti-IL-4Rα antibody to a subject, wherein the anti-IL-4Rα antibody comprises:
a variable heavy chain CDR1 of
SEQ ID NO: 1
(GFTFRDYA);
a variable heavy chain CDR2 of
SEQ ID NO: 2
(ISGSGGNT);
a variable heavy chain CDR3 of
SEQ ID NO: 3
(AKDRLSITIRPRYYGLDV);
a variable light chain CDR1 of
SEQ ID NO: 4
(QSLLYSIGYNY);
a variable light chain CDR2 of
SEQ ID NO: 5
(LGS);
and
a variable light chain CDR3 of
SEQ ID NO: 6
(MQALQTPYT),
wherein the anti-IL-4Rα antibody is formulated as a pharmaceutical composition comprising an acceptable carrier.
2 . The method of claim 1 , wherein the lung-related disorder is lung fibrosis, lung cirrhosis, chronic fibrotic lung disease, cystic fibrosis, bleomycin-induced pneumopathy and fibrosis, pulmonary alveolar proteinosis, adult respiratory distress syndrome, sarcoidosis, tuberculosis, aspirin-exacerbated respiratory disease, or a combination thereof.
3 . The method of claim 1 , wherein the anti-IL-4Rα antibody comprises a heavy chain variable region (VH) comprising SEQ ID NO: 13 and a light chain variable region (VL) comprising SEQ ID NO: 14.
4 . The method of claim 1 , wherein the anti-IL-4Rα antibody comprises a heavy chain comprising SEQ ID NO: 17 and a light chain comprising SEQ ID NO: 18.
5 . The method of claim 1 , wherein the subject is human.
6 . The method of claim 1 , wherein the administering is intradermal, intramuscular, intraperitoneal, intravenous, intranasal, or epidural administration.
7 . The method of claim 1 , wherein the administering is subcutaneous.
8 . The method of claim 1 , wherein the anti-IL-4Rα antibody is diluted in a 2 mL solution in a single-dose pre-filled syringe.
9 . The method of claim 1 , wherein the administering is via a pre-filled syringe, a pre-filled pen, or an autoinjector.
10 . The method of claim 9 , wherein the administering is subcutaneous.
11 . The method of claim 1 , wherein the anti-IL-4Rα antibody is administered to the subject as an initial dose followed by a secondary dose.
12 . The method of claim 11 , wherein the initial dose is about 600 mg and the secondary dose is about 300 mg.
13 . The method of claim 11 , wherein the initial dose is about 400 mg and the secondary dose is about 200 mg.
14 . The method of claim 11 , wherein the secondary dose is administered every 1 to 14 weeks after the initial dose.
15 . The method of claim 14 , wherein the secondary dose is administered every 2 weeks.
16 . The method of claim 1 , wherein the anti-IL-4Rα antibody is administered at a dose of about 0.0001 mg/kg to about 10 mg/kg of patient body weight.
17 . The method of claim 1 , further comprising administering a second therapeutic agent selected from a second antibody or antigen binding fragment thereof, a soluble cytokine receptor, an IgE antagonist, or an anti-asthma medication.
18 . The method of claim 17 , wherein the anti-asthma medication is a corticosteroid, a non-steroidal agent, a beta agonist, a leukotriene antagonist, a xanthine, fluticasone, salmeterol, or albuterol.
19 . The method of claim 1 , further comprising, prior to administering the therapeutically effective amount of the anti-IL-4Rα antibody, selecting the subject exhibiting one or more symptoms of the IL-4Rα-related disorder.
20 . The method of claim 1 , further comprising, prior to administering the therapeutically effective amount of the anti-IL-4Rα antibody:
clustering, by a computer system, a subset of patients from a plurality of patients, wherein the subset of patients comprises a characteristic or a plurality of characteristics related to an IL-4/IL-13 pathway; and
identifying in the subset of patients the IL-4Rα-related disorder based on one or more symptoms associated with the characteristic or the plurality of characteristics related to the IL-4/IL-13 pathway.