Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis (RA) in the Annals of the Rheumatic Diseases.
In the open-label, multicenter, head-to-head randomized, three-way crossover study, patients ≥18 years with RA undergoing treatment with MTX for ≥3 months were assigned to receive one of four doses of Otrexup 10mg, 15mg, 20mg, or 25mg weekly in a random sequence of three treatments: oral, subcutaneous into the abdomen, and subcutaneous into the thigh.
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Blood samples were collected for 24 hours after administration of each treatment to measure drug levels. Injection sites were also assessed. Forty-seven patients completed the study and the results showed that the systemic availability of methotrexate following oral dosing plateaus at 15mg and greater. Following administration of Otrexup, the systemic availability increased proportionally at every dose, which extended the range of exposure compared to patients receiving oral therapy.
Otrexup, a folate analog metabolic inhibitor is already approved for the management of adults with severe, active rheumatoid arthritis or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose NSAIDs. It is also indicated for symptomatic control of severe, recalcitrant, disabling psoriasis in adults with inadequate response to other forms of therapy, but only with an established diagnosis as by biopsy and/or dermatologic consultation.
For more information call (855) 687-3987 or visit Otrexup.com.