Abbott announced that the US Food and Drug Administration (FDA) approved the Humira Pen, a new device for administering Humira (adalimumab), a treatment approved for moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA). With its one-touch activation and easy-to-grasp size and shape, the Humira Pen offers improved ease of use for these patients, many of whom may have swelling or stiffness in the hands.
The Humira Pen has a needle that is not visible during the injection process, and this device provides a less painful experience for some patients. Patients place the Humira Pen against the skin, press a button, and wait for the medicine to inject. The Humira Pen will be available to US patients beginning in August, a company release said.
Currently, Humira is taken as a subcutaneous injection (injection beneath the skin) via a specially designed prefilled syringe. Humira is currently indicated for moderate to severe rheumatoid arthritis and for active arthritis in patients with psoriatic arthritis and is being studied as a possible treatment for other autoimmune diseases.
In results of the TOUCH (Trial Of Usability in Clinical settings of Humira Autoinjector vs. Prefilled Syringe) study, which included 52 Humira prefilled syringe patients, approximately nine out of 10 preferred the new Humira Pen, rating it more convenient and easier to use, while approximately eight out of 10 found it to be less painful.
"Injectable medications are among the most effective treatments we have for RA and PsA, but nobody enjoys receiving an injection," said Alan Kivitz, M.D., practicing rheumatologist and founder of the Altoona (Pa.) Center for Clinical Research. "The Humira Pen is an important advance because it offers people a convenient administration option to treat their disease."
The medicine used in the Humira Pen will be identical to that used in the prefilled syringe and the standard dosing, 40 mg every other week, remains the same.
"With the approval of the Humira Pen, Abbott furthers its goal of empowering patients to treat these potentially debilitating autoimmune diseases as conveniently as possible," said Rebecca Hoffman, divisional vice president, Immunology Development, Abbott.
The objective of the TOUCH study was to assess which method of delivery rheumatoid arthritis patients preferred: the Humira prefilled syringe that they were already using, or the new Humira Pen. This study included RA patients (N=52) who had prior experience with the Humira prefilled syringe and tried the new Humira Pen. Patients rated their injection preferences for several attributes, including overall preference, ease of use, convenience, time to complete injection and pain.
Humira is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Humira can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
Humira is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. Humira can be used alone or in combination with DMARDs.