Sunday, May 05, 2013 12:00:31 PM
A future/potential Vibex pen use MTX with add on DMARD.
Back on Feb 16, 2013 I posted this on the ymb:
Formula: MTX + Medi-Jet = ATRS (+TNF alpha) = ATRS delivery of Biologics for the treatment of DMARD’s
MTX = methotrexate
Medi-Jet = Antares delivery device
TNF alpha = tumor necrosis factor (Currently available biologic agents act as inhibitors of the cytokines IL-1 or TNF. Cytokines are messenger molecules made by many of the body's cells that act to excite other immune system cells. Interleukin-1 (L-1) and tumor necrosis factor (TNF) are made in large amounts in rheumatoid arthritis and other forms of inflammation)
DMARD = Disease Modifying antirheumatic drugs
MTX is considered the first line therapy for the treatment of rheumatoid arthritis (RA) and a top line therapy for poly-articular-course juvenile RA and moderate to severe psoriasis.
Antares has the first and only Subcutaneous, MTX single use, once weekly disposable device (the Medi-Jet) capable of administering MTX doses from 10, 15, 20 to 25 mg.
I’m going to argue, this avenue of MTX delivery by Antares is unique, forward thinking and a potential “trend setter” for the delivery of future biologics when used in combination with MTX.
From today’s GaBi online (whogo, you are familiar with this publication):
Development of biosimilars for rheumatologyPosted 03/05/2013
http://gabionline.net/Biosimilars/Research/Development-of-biosimilars-for-rheumatology?utm_source=GONL2&utm_campaign=712902ae0d-GONL+V13E03E05&utm_medium=email&utm_term=0_e096b353ae-712902ae0d-309520813
In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biological treatments for arthritis are costing patients between US$10,000–US$30,000 per year making the need for lower cost biosimilars clear [1].
There are currently no biosimilar monoclonal antibodies (mAbs) or soluble receptor constructs (cepts—large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate) approved by EMA or FDA for treatment of rheumatic diseases, although randomized controlled trials are complete or ongoing, see Table 4 [1]. EMA is, however, reviewing two applications for marketing authorization of infliximab biosimilars, one of which is thought to come from South Korean biotechnology company Celltrion, which has already received approval for its product for rheumatoid arthritis and autoimmune diseases from the regulatory authorities in Korea [2].
Biosimilars, as with all biologicals, are complex molecules to produce, and uncertainties surrounding the exact regulatory requirements have led some companies to suspend their development. This, however, has not put off others and, with patent expiries looming, rheumatologist should expect biosimilars to be with them very soon.
Rituximab (marketed as Rituxan) Information
Rituxan is a prescription medicine used to treat:
• Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines
• Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide
• Rheumatoid Arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well enough
• Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA
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