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Rheumatologists
can now recommended Secukinumab SC for active
nonradiographic axial spondyloarthritis (nr-axSpA).
As announced by a leading Swiss multinational pharmaceutical company on 17 June, 2020, the Food and Drug Administration (FDA) has sanctioned its Secukinumab (interleukin-17A antagonist) subcutaneous (SC) formulation to include active nonradiographic axial spondyloarthritis (nr-axSpA) in its indications with inflammatory signs. Secukinumab SC was initially approved for plaque psoriasis on 21 January, 2015.
The present approval is based on the outcomes of PREVENT study in 555 patients suffering from active nr-axSpA who were biologic treatment naïve or with inappropriate response to anti-TNFs. Secukinumab 150mg SC monthly with a loading dose (secukinumab 150mg weekly/4 weeks) in 185 patients, secukinumab 150mg SC monthly with no loading dose in 184 patients, or placebo (186 patients).
At week 52, statistically significant improvements in the ASAS40 (Assessment of Spondyloarthritis International Society) response were observed in Secukinumab treated, biologic therapy naïve patients. Clinical response was perceived in 40% and 41% of secukinumab-treated patients with or without the loading dose than 28% of patients in placebo.
Also, at week 16, Secukinumab-treated patients had superior improvements as examined via the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), hs-CRP (high sensitivity C-reactive protein with time), and BASMI (Bath Ankylosing Spondylitis Metrology Index). Diarrhea, nasopharyngitis, and upper RTI were frequently observed adverse reactions.
Cosentyx Approved for Nonradiographic Axial Spondyloarthritis
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