Methotrexate is an antimetabolite and antifolate agent with antineoplastic and immunosuppressant activities. Methotrexate binds to and inhibits the enzyme dihydrofolate reductase, resulting in inhibition of purine nucleotide and thymidylate synthesis and, subsequently, inhibition of DNA and RNA syntheses. Methotrexate also exhibits potent immunosuppressant activity although the mechanism(s) of actions is unclear.
Methotrexate is approved by the Food and Drug Administration (FDA) to be used by itself to treat the following types of gestational trophoblastic tumors, Chorioadenoma destruens, Choriocarcinoma, Hydatidiform mole. Methotrexate is also approved to be used alone or with other drugs to treat acute lymphoblastic leukemia (ALL) that has spread to the central nervous system (CNS) or to keep it from spreading there, and to treat the following, breast cancer, certain types of head and neck cancer, lung cancer, advanced non-Hodgkin lymphoma (NHL), advanced mycosis fungoides (a type of cutaneous T-cell lymphoma), osteosarcoma that has not spread to other parts of the body, following surgery to remove the primary tumor. Methotrexate is also approved to treat the following non-cancer conditions, rheumatoid arthritis, severe psoriasis.
The study will examine how much of an improvement in pain, stiffness, function and other symptoms is needed before patients consider the change important.
A new clinical study to determine how people with rheumatoid arthritis (RA) evaluate improvements in disease symptoms will be carried out by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the Department of Health and Human Services' National Institutes of Health.
Committee for Medicinal Products for Human Use of the European Agency for the Evaluation of Medicinal Products has issued a positive opinion recommending approval of expanded labeling for REMICADE(R) (infliximab), in combination with methotrexate, for treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to disease modifying anti- rheumatic drugs (DMARDs).
The difference in cost associated with using two common treatments for psoriasis over the course of one year with treatment lasting 16 weeks are small.
Genentech, Inc., Biogen Idec and Roche have announced that the New England Journal of Medicine published the results of a Phase IIa study showing that two doses of Rituxan® (Rituximab), administered two weeks apart, improved symptoms in patients with moderate-to-severe rheumatoid arthritis (RA) for up to 48 weeks when combined with methotrexate (MTX), compared to MTX alone.
New results from TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) demonstrated that Enbrel® (etanercept) therapy allowed significantly more rheumatoid arthritis (RA) patients to achieve clinical remission at two years compared to patients treated with methotrexate alone.
Centocor, Inc., and Schering-Plough Corporation announced today the initiation of the SONIC (Study of Immunomodulator Naive patients in Crohn's Disease) trial that will evaluate the efficacy of REMICADE® (infliximab) versus azathioprine, a conventional immunosuppressive agent, alone and versus the combination of both drugs for the treatment of patients with Crohn's disease.
Centocor, Inc., announced today that more than a half million patients worldwide have now been treated with the anti-TNF agent REMICADE® (infliximab) since it was introduced in the United States five years ago.
A drug duo appears to be a safe and effective way to prevent a serious condition called graft-versus-host-disease (GVHD) in youngsters undergoing a stem cell transplant
Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted its filing of a supplemental Biologics License Application (sBLA) for REMICADE® (infliximab) as first-line therapy, in combination with methotrexate, for the treatment of early rheumatoid arthritis (RA) patients with moderately-to-severely active disease. REMICADE®, in combination with methotrexate, is currently indicated in the U.S. for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately-to-severely active RA who have had an inadequate response to methotrexate alone.