‘This gives us more leeway’: Intravenous secukinumab effective in axial spondyloarthritis
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SAN DIEGO — An intravenous formulation of secukinumab met all primary efficacy endpoints, with an attractive safety profile, in patients with axial spondyloarthritis over 52 weeks, according to data presented at ACR Convergence 2023.
“Secukinumab in subcutaneous injection form is already approved for the treatment of the entire spectrum of axial spondyloarthritis — radiographic, and non-radiographic,” Atul Deodhar, MD, of the division of arthritis and rheumatic disease at Oregon Health & Science University, in Portland, told Healio. “We thought that the option of an IV preparation of secukinumab would offer flexibility in treatment decisions made by patients and providers, especially in the United States, considering the medical insurance landscape.”
To analyze the long-term efficacy and safety of intravenous secukinumab (Cosentyx, Novartis) in patients with either radiographic or non-radiographic axial SpA, Deodhar and colleagues conducted INVIGORATE-1, a randomized, double blind, parallel group, phase 3 trial. Eligible participants met the New York or Assessment of SpondyloArthritis international Society (ASAS) criteria for axial SpA, were aged younger than 45 years at disease onset, and reported inflammatory back pain for at least 6 months.
Participants were randomized 1:1 to 6 mg/kg of intravenous secukinumab at baseline followed by 3 mg/kg every 4 weeks, or placebo, for 16 weeks. At that time point, patients in the placebo arm were switched to intravenous secukinumab 3 mg/kg every 4 weeks, while patients in the original secukinumab arm remained on that regimen through 52 weeks.
ASAS40 response, along with Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP major improvement and ASAS5/6 response, served as primary outcome measures. The researchers also assessed participants for change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and SF-36 PCS. Safety outcomes also underwent analysis.
The treatment and placebo groups were balanced in terms of baseline demographics.
There were 264 patients in the secukinumab arm and 262 assigned to the placebo/switch group. There were 413 patients with radiographic disease and 113 with non-radiographic disease.
According to the researchers, secukinumab was associated with “rapid and sustained improvement” in ASAS40 response. By week 24, patients who switched from placebo to secukinumab reported similar response rates as patients in the original secukinumab arm. ASAS40 responses were maintained through week 52, with 66.8% of patients in the secukinumab arm, and 74.9% of those in the placebo/switch arm, reaching this endpoint. At week 52, ASDAS-CRP response rates were 43.3% in the original secukinumab arm and 52.5% in the switch arm, while ASAS5/6 response rates were 63.8% for secukinumab and 65.9% for the switch arm.
At week 16, adverse events occurred in 38.6% of patients in the secukinumab arm and 39.1% of those assigned placebo. Serious events occurred in 2.7% of participants in the secukinumab arm and in 1.1% of those in the placebo group. Discontinuations were reported for 1.9% of those in the treatment arm and 0.4% of participants assigned placebo.
Among all patients receiving any intravenous secukinumab throughout the study duration, 63.2% reported an adverse event, 6% reported a serious event and 3.5% experienced an event leading to discontinuation.
“There were no surprises in the study,” he said. “The primary and all the secondary endpoints were met. The secukinumab IV preparation was efficacious and safe in the use of axial spondyloarthritis.
“I always like medicines, including biologics, that have dose flexibility,” he added. “I would have liked to look at response to higher dosages of secukinumab in patients who do not respond to the current approved doses. With the IV preparation, one could conceivably do studies of repeating the infusions more frequently, and/or increasing the weight-based dose. These are some of the studies I would like to see in the future.”
According to Deodhar, many patients on Medicare prefer intravenous medication due to payer concerns.
“In addition, there are other patients who do not like to inject themselves and prefer IV preparations,” he said. “The newly approved IV secukinumab therefore gives rheumatologists an additional option for an intravenous biologic in the treatment of axial SpA.
“The take-home message for rheumatologists is that an already established biologic, with proven efficacy and safety, is now available in an IV formulation to treat patients with axial spondyloarthritis,” he added. “This gives us more leeway in the management of these patients.”
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Deodhar A. Abstract 2545. Presented at: ACR Convergence 2023; Nov. 10-15, 2023; San Diego.
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