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The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.
FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.
A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.
The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.
Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.
FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.
A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.
The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.
Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.
FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.
A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.
The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.
Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.