Therapeutic agent for autoimmune diseases comprising PD-1 agonist
AssigneeOno Pharmaceutical Co., Ltd.
InventorsShiro Shibayama, Masamichi Imai
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Abstract
Provided is a prophylactic, symptom progress-suppressive, and/or therapeutic agent for an autoimmune disease. The agent lowers the risk of infections and reduces the burden of administration to patients. The prophylactic, symptom progress-suppressive, and/or therapeutic agent includes a PD-1 agonist as an active ingredient and is administered (a) 1 to 10 times within one month from the first administration, (b) in a total PD-1 agonist dose of 20 to 1250 μg/kg, and (c) without requiring administration for at least 3 months after the last administration.
Claims21
A symptom progress-suppressive and/or therapeutic method for treating an autoimmune disease, comprising administering an agent comprising a PD-1 agonist as an active ingredient to a subject,
- wherein the method comprises an administration period and a break period following the administration period,
- wherein (a) the administration period is of one month or less and comprises 1 to 10 times of the administration of the agent, (b) a total dose of the PD-1 agonist of the administration period is 20 μg/kg or more, and (c) the break period, during which the agent is not administered to the subject, ends at least 3 months after a last administration of the administration period, and
- wherein the PD-1 agonist is an anti-PD-1 agonist antibody or an anti-PD-1-CD3 bispecific antibody.
A method for sustaining a symptom progress-suppressive and/or therapeutic effect in an autoimmune disease for at least 3 months after a last administration of a PD-1 agonist, comprising administering the PD-1 agonist to a patient having the autoimmune disease,
- wherein the method comprises an administration period and a break period following the administration period,
- wherein the administration period is of one month or less and comprises 1 to 10 times of the administration of the PD-1 agonist at a total dose of 20 μg/kg or more, and the break period, during which the PD-1 agonist is not administered to the subject, ends at least 3 months after the last administration of the administration period, and wherein the PD-1 agonist is an anti-PD-1 agonist antibody or an anti-PD-1-CD3 bispecific antibody.
A symptom progress-suppressive and/or therapeutic method for an autoimmune disease, comprising administering an agent comprising a PD-1 agonist as an active ingredient to a subject,
- wherein the method comprises an administration period and a break period following the administration period,
- wherein (a) the administration period is of one month or less and comprises 1 to 10 times of the administration of the agent,
- (b) a total dose of the PD-1 agonist in of the administration period is 20 μg/kg or more, and
- (c) the break period, during which the agent is not administered to the subject, ends at least 3 months after a last administration of the administration period, and
- wherein the PD-1 agonist is an anti-PD-1 agonist antibody or an anti-PD-1-CD3 bispecific antibody.
A symptom progress-suppressive and/or therapeutic method for treating an autoimmune disease, comprising administering an agent comprising a PD-1 agonist as an active ingredient to a subject,
- wherein the method comprises an administration period and a break period following the administration period,
- wherein (a) the administration period is of one month or less and comprises 2 to 10 times of the administration of the agent,
- (b) a total dose of the PD-1 agonist of the administration period is 20 μg/kg or more, and
- (c) the break period, during which the agent is not administered to the subject, ends at least 3 months after a last administration of the administration period.
A method for sustaining a symptom progress-suppressive and/or therapeutic effect in an autoimmune disease for at least 3 months after a last administration of a PD-1 agonist, comprising administering the PD-1 agonist to a patient having the autoimmune disease,
- wherein the method comprises an administration period and a break period following the administration period,
- wherein the administration period is of one month or less and comprises 2 to 10 times of the administration of the PD-1 agonist at a total dose of 20 μg/kg or more, and the break period, during which the PD-1 agonist is not administered to the subject, ends at least 3 months after the last administration of the administration period.
A symptom progress-suppressive and/or therapeutic method for an autoimmune disease, comprising administering an agent comprising a PD-1 agonist as an active ingredient to a subject,
- wherein the method comprises an administration period and a break period following the administration period,
- wherein (a) the administration period is of one month or less and comprises 2 to 10 times of the administration of the agent,
- (b) a total dose of the PD-1 agonist in of the administration period is 20 μg/kg or more, and
- (c) the break period, during which the agent is not administered to the subject, ends at least 3 months after a last administration of the administration period.
Dependencies are inferred from the claim text.