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Rheumatoid Arthritis :FDA-approved Orencia ClickJect for Rheumatoid Arthritis Launched by BMS

Bristol-Myers Squibb has launched its U.S. FDA-approved Orencia ClickJect Autoinjector for adults with moderate to severe rheumatoid arthritis (RA).

Orencia (abatacept) is a modified antibody drug that interferes with the immune activity of T-cells and can treat the symptoms of rheumatoid arthritis preventing joint damage. It is also used to treat arthritis in children who are at least 6 years old.

Each single dose of a subcutaneous injection provides 125 mg abatacept, dibasic sodium phosphate anhydrous (0.838 mg), monobasic sodium phosphate monohydrate (0.286 mg), poloxamer 188 (8 mg) and sucrose (170 mg). Unlike the intravenous formulation, Orencia solution for subcutaneous administration contains no maltose.

The company said Orencia ClickJect has an ergonomic design and a nonslip grip for better control for patients who have problems with dexterity. Orencia offers three options of administration: autoinjector, intravenous infusion, and prefilled syringe.

Orencia should not be administered with antagonists of tumor necrosis factor (TNF), and should not be use with other biologic rheumatoid arthritis treatment.

“Today’s launch of the Orencia ClickJect is an example of our continued commitment to offering patients with moderate to severe rheumatoid arthritis a treatment option that may be appropriate for them, now available as an autoinjector,” Chris Boerner, head of U.S. Commercial at Bristol-Myers Squibb, said in a press release. “This approval offers more options for healthcare providers and members of the arthritis community to consider when selecting the optimal treatment and administration option for each individual.”

A study conducted in 48 patients evaluated the usability and acceptability of Orencia ClickJect Autoinjector on key characteristics including comfort, control, ease of use, and dose confidence. The mean scores for Orencia across criteria ranged with the patient group from 6.4 to 6.9, where 7 was considered very acceptable in terms of user experience.

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Orencia may also be an appropriate option for patients with moderate to severe rheumatoid arthritis. In the AGREE Phase 3b study, a multinational, randomized, double-blind, 12-month clinical trial that evaluated patients who had never taken methotrexate (MTX) with early, rapidly progressing RA patients, Orencia intravenous plus MTX exhibited significant efficacy compared with MTX alone.

The trial met its co-primary outcomes as defined by patients reaching DAS28-CRP less than 2.6 (a disease activity score calculator for RA) — 41 percent versus 23 percent, respectively —  and inhibition of radiographic progression.

“Rheumatoid arthritis often affects joints in the hand and impairs dexterity. Through the new Orencia ClickJect, we are able to offer the proven benefits of Orencia in an accurate dose self-injection and provide an additional option for healthcare providers when selecting treatment options for their patients,” said Dr. Sheila Kelly, MD, U.S. Orencia Medical Lead, Bristol-Myers Squibb.

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