FDA News

FDA approves Cimzia for nonradiographic axial SpA

Jeffrey Stark

The FDA has approved Cimzia for the treatment of adults with nonradiographic axial spondyloarthritis with objective signs of inflammation, making it the first ever medication approved for the condition, according to a press release.

“Until now, nonradiographic axial SpA has not been well-recognized by the medical community in the U.S., partly due to a lack of understanding of the disease history, progression, and how it differs in diagnosis and treatment from ankylosing spondylitis.” Jeffrey Stark, MD, head of U.S. Medical Affairs in Rheumatology at UCB, and a practicing rheumatologist, told Healio Rheumatology. “Patients with nonradiographic axial SpA have significant disease burden, which often goes undiagnosed up to nine years from the onset of first symptoms.”

Stark added “As a practicing rheumatologist, I know that this FDA approval for Cimzia will have a dramatic impact on the way we address the needs of these patients and provide a clinically validated treatment for this specific disease sooner.”

 
The FDA has approved Cimzia for the treatment of adults with nonradiographic axial SpA with objective signs of inflammation.
Source: Adobe

The approval follows C-AXSPAND, a phase 3 randomized clinical trial that demonstrated greater responses among patients who were treated with Cimzia (certolizumab pegol, UCB) compared with those who received placebo. The trial included 317 adult patients with nonradiographic axial SpA, with objective signs of inflammation based on elevated C-reactive protein levels and sacroiliitis on MRI.

The researchers measured improvements in participants’ Ankylosing Spondylitis Disease Activity Score, as well as the presence of any new adverse effects. According to the FDA, the safety profile observed in those treated with Cimzia, a TNF inhibitor, was consistent with previous data.

“Historically, many nonradiographic axial SpA patients have experienced delayed diagnoses and have been sub-optimally treated with non-biologic, slow-acting antirheumatic drugs and/or analgesics that do not address the underlying cause of their inflammatory back pain,” Stark said. “Cimzia will now allow nonradiographic axial SpA patients to receive appropriate treatment with a biologic, which may be able to reduce the severe pain, stiffness and other burdensome symptoms associated with nonradiographic axial SpA, ultimately improving their quality of life.”

The prescribing data includes a boxed warning to advise health care professionals and patients regarding an increased risk for serious infections — leading to hospitalization or death — including tuberculosis, bacterial sepsis and invasive fungal infections.

According to the FDA, Cimzia treatments should be stopped if a patient develops serious infection or sepsis. In addition, the FDA is advising providers to test patients for latent tuberculosis and, if positive, begin treatment for that before initiating Cimzia. According to the FDA, providers should also monitor all patients for active tuberculosis during Cimzia treatment, even if the initial test was negative.

The boxed warning also advises that lymphoma and other malignancies have been reported in children and adolescents treated with TNF inhibitors. According to the FDA, Cimzia is not indicated for pediatric patients, and for adults, must be dispensed with a medication guide describing the drug’s uses and risks.

Originally approved by the FDA in 2008, Cimzia had previously been indicated for adult patients with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis and moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy.

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Jeffrey Stark

The FDA has approved Cimzia for the treatment of adults with nonradiographic axial spondyloarthritis with objective signs of inflammation, making it the first ever medication approved for the condition, according to a press release.

“Until now, nonradiographic axial SpA has not been well-recognized by the medical community in the U.S., partly due to a lack of understanding of the disease history, progression, and how it differs in diagnosis and treatment from ankylosing spondylitis.” Jeffrey Stark, MD, head of U.S. Medical Affairs in Rheumatology at UCB, and a practicing rheumatologist, told Healio Rheumatology. “Patients with nonradiographic axial SpA have significant disease burden, which often goes undiagnosed up to nine years from the onset of first symptoms.”

Stark added “As a practicing rheumatologist, I know that this FDA approval for Cimzia will have a dramatic impact on the way we address the needs of these patients and provide a clinically validated treatment for this specific disease sooner.”

 
The FDA has approved Cimzia for the treatment of adults with nonradiographic axial SpA with objective signs of inflammation.
Source: Adobe

The approval follows C-AXSPAND, a phase 3 randomized clinical trial that demonstrated greater responses among patients who were treated with Cimzia (certolizumab pegol, UCB) compared with those who received placebo. The trial included 317 adult patients with nonradiographic axial SpA, with objective signs of inflammation based on elevated C-reactive protein levels and sacroiliitis on MRI.

The researchers measured improvements in participants’ Ankylosing Spondylitis Disease Activity Score, as well as the presence of any new adverse effects. According to the FDA, the safety profile observed in those treated with Cimzia, a TNF inhibitor, was consistent with previous data.

“Historically, many nonradiographic axial SpA patients have experienced delayed diagnoses and have been sub-optimally treated with non-biologic, slow-acting antirheumatic drugs and/or analgesics that do not address the underlying cause of their inflammatory back pain,” Stark said. “Cimzia will now allow nonradiographic axial SpA patients to receive appropriate treatment with a biologic, which may be able to reduce the severe pain, stiffness and other burdensome symptoms associated with nonradiographic axial SpA, ultimately improving their quality of life.”

The prescribing data includes a boxed warning to advise health care professionals and patients regarding an increased risk for serious infections — leading to hospitalization or death — including tuberculosis, bacterial sepsis and invasive fungal infections.

According to the FDA, Cimzia treatments should be stopped if a patient develops serious infection or sepsis. In addition, the FDA is advising providers to test patients for latent tuberculosis and, if positive, begin treatment for that before initiating Cimzia. According to the FDA, providers should also monitor all patients for active tuberculosis during Cimzia treatment, even if the initial test was negative.

The boxed warning also advises that lymphoma and other malignancies have been reported in children and adolescents treated with TNF inhibitors. According to the FDA, Cimzia is not indicated for pediatric patients, and for adults, must be dispensed with a medication guide describing the drug’s uses and risks.

Originally approved by the FDA in 2008, Cimzia had previously been indicated for adult patients with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis and moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy.

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