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 final results from an international clinical trial involving nearly 2,000 patients with Crohn's disease support the use of a new management strategy referred to as accelerated step-care as a best practice for the care of active Crohn's disease.
Children newly diagnosed with Crohn's disease may benefit from early treatment with the biologic drugs known as anti-TNF-α agents, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association.
Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced the FDA acceptance of its New Drug Application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection device, for which the proposed indications are rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
Bristol-Myers Squibb Company today reported results for the fourth quarter and full year of 2013. The fourth quarter was highlighted by the company's announcement to sell its diabetes business as part of the continued evolution of its successful BioPharma strategy to a specialty care model. The company achieved important regulatory milestones in the quarter for Eliquis in the U.S., daclatasvir/asunaprevir in Japan, daclatasvir in Europe and Farxiga in the U.S. In addition, the company provided financial guidance for 2014.
New research shows mortality rates are two times higher in postmenopausal women with rheumatoid arthritis (RA) and anti-cyclic citrullinated peptide (anti-CCP) antibodies. Findings published in the American College of Rheumatology (ACR) journal Arthritis & Rheumatism, soon to be called Arthritis & Rheumatology, indicate the higher mortality rates persisted after adjusting for age, positive rheumatoid factor, positive antinuclear antibodies (ANA) and disease modifying anti-rheumatic drug (DMARD) use.
Antares Pharma, Inc. today announced that it has received a Notice of Allowance from the U.S. Patent Office for application 13/584,317. This application, along with U.S. Patent 8,251,947 granted in August of 2012, relate to Antares' injector technology for wet-dry injectable drugs such as lyophilized biologicals or peptide drugs that require dry storage to assure stability.
The anti-TNF-α biologic agents, such as infliximab or adalimumab, are recommended to induce remission in patients with moderately severe Crohn's disease , according to a new guideline from the American Gastroenterological Association. Additionally, the guidelines recommend against using thiopurines or methotrexate alone to induce remission in these patients. The new guideline and accompanying technical review have been published in Gastroenterology, the official journal of the AGA Institute.
Adding bortezomib (Velcade) to standard preventive therapy for graft-versus-host-disease (GVHD) results in improved outcomes for patients receiving stem-cell transplants from mismatched and unrelated donors, according to researchers from Dana-Farber Cancer Institute.
Atopix Therapeutics Ltd, a biopharmaceutical company developing innovative CRTH2 antagonists for allergic disease, announced the recruitment of the first patient in a six month Phase 2 clinical trial of its lead compound OC459 in moderate-to-severe atopic dermatitis (eczema).
New findings from two integrated Phase 3 Janssen Research & Development, LLC (Janssen)-sponsored studies showed treatment with STELARA- (ustekinumab) resulted in significantly greater inhibition of structural damage in patients with active psoriatic arthritis compared with placebo.
Incyte Corporation (Nasdaq: INCY) announced results from a 12-week, placebo-controlled, dose-escalationin involving 60 patients with active rheumatoid arthritis for its proprietary oral JAK1 inhibitor.
Medicaid beneficiaries with lupus are not adequately following their treatment plans, and this puts them at risk for poor health outcomes, according to research presented this week at the American College of Rheumatology Annual Meeting in San Diego. For most lupus medications, fewer than one in three beneficiaries were found to be adherent.
Starting with a combination of three traditional disease-modifying antirheumatic drugs (called DMARDs) for treating early rheumatoid arthritis is more cost-effective long term, with comparable benefits, than using either an immediate or step-up approach with anti-tumor necrosis factor (called Anti-TNFs) drugs and methotrexate, according to new research findings presented this week at the American College of Rheumatology Annual Meeting in San Diego.
Children with juvenile idiopathic arthritis who receive early, aggressive therapy with a combination of medications achieve clinical inactive disease status faster than they would with less aggressive therapy, according to new research presented this week at the American College of Rheumatology Annual Meeting in San Diego.
A new study published in the current issue of the Journal of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS) suggests that the biologic agent adalimumab may be a viable treatment option for patients with steroid-resistant refractory pediatric uveitis.
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of Actemra (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced 12-week results from an ongoing Phase 2b study of VX-509, an investigational oral, selective Janus kinase 3 (JAK3) inhibitor, dosed once or twice daily in people with active rheumatoid arthritis (RA) taking methotrexate
UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis.
Antares Pharma, Inc. today announced the approval of OTREXUP (methotrexate) injection by the U.S. Food and Drug Administration. OTREXUP is the first FDA approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector.
AbbVie (NYSE: ABBV) today announced results from a post-hoc analysis of an investigational Phase II study, which evaluated HUMIRA® (adalimumab) in the treatment of patients with moderate-to-severe hidradenitis suppurativa (HS) after 16 weeks of therapy.
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