Emma Hitt, PhD
August 2, 2011 — The US Food and Drug Administration (FDA) has approved a subcutaneous formulation of abatacept (Orencia, Bristol-Myers Squibb Co) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA).
The new self-injectable formulation is a fixed 125-mg dose administered subcutaneously once a week after a single intravenous loading dose of approximately 10 mg/kg.
"Physicians now have a new option of a non-anti-TNF [tumor necrosis factor], with a different mechanism of action, when administering a biologic in a subcutaneous formulation," stated Mark C. Genovese, MD, professor of medicine and co-chief, Division of Immunology and Rheumatology, Stanford University Medical Center, California, and lead investigator of the registrational study supporting the approval, in a company press release.
"The [abatacept] subcutaneous formulation demonstrated efficacy and safety consistent with the intravenous formulation. This choice is important for both patients and physicians when managing moderate to severe RA," he added.
Patients who are unable to receive an infusion may initiate weekly injections of subcutaneous abatacept without an intravenous loading dose. "Patients transitioning from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose," the release stated.
According to the company, abatacept is the first and only biologic for the treatment of RA available in a self-injectable subcutaneous and in an intravenous infusion formulation.
"Since the majority of RA patients initiating therapy with a biologic receive their treatment by subcutaneous injection, the approval of [subcutaneous abatacept] offers physicians a choice for more of their patients."
In a large trial, subcutaneous abatacept was noninferior compared with intravenous dosing in terms of responses to American College of Rheumatology (ACR) 20 criteria at 6 months and safety. However, abatacept should not be used concurrently with TNF antagonists.
In controlled clinical trials, patients receiving abatacept and TNF antagonist therapy experienced no additional efficacy benefit but more infections (63%) and serious infections (4.4%) compared with patients receiving only TNF antagonists (43% and 0.8%, respectively).
By comparison, with intravenous abatacept, serious infections occurred at an incidence of 3% compared with 1.9% in the placebo group, while the rate of malignancies was 1.3% with abatacept compared with 1.1% with placebo.
Abatacept may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs other than TNF antagonists, but it is not recommended for use concomitantly with other biologic RA therapies, such as anakinra.
Abatacept is indicated 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.
اللَّهُمَّ نَجِّ الْمُسْتَضْعَفِينَ مِنَ الْمُؤْمِنِينَ اللَّهُمَّ اشْدُدْ وَطْأَتَكَ عَلَى مُضَرَ اللَّهُمَّ اجْعَلْهَا عَلَيْهِمْ سِنِينَ كَسِنِي يُوسُفَ