Treatment of autoimmune diseases
AssigneeUCB Developed Brands SRL
InventorsCarlos Javier Cara Terribas, Yoshiya Tanaka, Bernard Robert Jean Lauwerys, Baran Ufuktepe, Ana Barbadillo Ruiz
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Abstract
The present disclosure provides methods of treating a rheumatic disease in difficult to treat human patients being seropositive for rheumatoid factor using a biologic disease modifying anti-rheumatic drug lacking an Fc fragment. In some embodiments, the method includes treating patients having rheumatoid arthritis being seropositive for rheumatoid factor using the certolizumab pegol.
Claims46
A method of treating a rheumatic disease in a human patient having rheumatoid factor comprising:
- administering a bDMARD lacking an Fc fragment to a human patient identified as having rheumatoid factor above 100 IU/ml, above 121.4 IU/ml, above 125 IU/ml, above 145.9 IU/ml, above 150 IU/ml, above 175 IU/ml, above 200 IU/ml or above 204 IU/ml in serum;
- wherein (i) the therapeutic effect of the bDMARD lacking an Fc fragment is not reduced by RF in said patient and/or (i) the treatment induces low disease activity or achieves substantial clinical benefit in the patient.
A method of treating a rheumatic disease in a human patient having rheumatoid factor comprising:
- a) determining the titer of rheumatoid factor in a sample, preferably a serum sample, from said patient;
- b) administering a bDMARD lacking an Fc fragment to said patient if the titer of rheumatoid factor is above 100 IU/ml, above 121.4 IU/ml, above 125 IU/ml, above 145.9 IU/ml, above 150 IU/ml, above 175 IU/ml, above 200 IU/ml, above 204 IU/ml, above 225 IU/ml, above 250 IU/ml, or above 275 IU/ml in serum;
- wherein (i) the therapeutic effect of the bDMARD lacking an Fc fragment is not reduced by RF in said patient and/or (i) the treatment induces low disease activity or achieves substantial clinical benefit in the patient.
A method of treating rheumatoid arthritis in a human patient having rheumatoid factor comprising:
- administering certolizumab pegol to a human patient identified as having rheumatoid factor above 100 IU/ml, above 121.4 IU/ml, above 125 IU/ml, above 145.9 IU/ml, above 150 IU/ml, above 175 IU/ml, above 200 IU/ml or above 204 IU/ml in serum;
- wherein (i) the therapeutic effect of certolizumab pegol is not reduced by RF in said patient and/or (i) the treatment induces low disease activity or achieves substantial clinical benefit in the patient.
A method of treating rheumatoid arthritis in a human patient having rheumatoid factor comprising:
- a) determining the titer of rheumatoid factor in a sample, preferably a serum sample, from said patient;
- b) administering certolizumab pegol to said patient if the titer of rheumatoid factor is above 100 IU/ml, above 121.4 IU/ml, above 125 IU/ml, above 145.9 IU/ml, above 150 IU/ml, above 175 IU/ml, above 200 IU/ml, above 204 IU/ml, above 225 IU/ml, above 250 IU/ml, or above 275 IU/ml in serum;
- wherein (i) the therapeutic effect of certolizumab pegol is not reduced by RF in said patient and/or (i) the treatment induces low disease activity or achieves substantial clinical benefit in the patient.
A method of maintaining low disease activity or remission of a rheumatic disease in a human subject in need thereof, the method comprising:
- administering to the subject a dose of a bDMARD lacking an Fc fragment that is effective to maintain low disease activity or remission in the subject,
- wherein the subject is identified as having an elevated baseline rheumatoid factor (RF) serum level of more than 100 IU/ml.
The method of any one of claims 19-43, further comprising the earlier step of determining the serum level of RF of a subject having a rheumatic disease.
The method of any one of claims 19-44, wherein the RF is of the IgM, IgG, IgD, IgE or IgA isotype.
Dependencies are inferred from the claim text.