The TGA's greenlight of fortnightly secukinumab has been welcomed by psoriasis experts.
Dermatologists have welcomed the TGA’s approval for individualised dosing of secukinumab for plaque psoriasis, saying it will be particularly beneficial for heavier patients.
The move follows a study published in the British Journal of Dermatology earlier this year which found secukinumab (Cosentyx, Novartis Australia) dosing every two weeks demonstrated superior efficacy compared with dosing every four weeks in patients weighing 90kg or more with moderate to severe plaque psoriasis.
Melbourne dermatologist and Dermatology Republic Editor, Professor Rod Sinclair, said the TGA’s approval would be welcomed by Australian dermatologists.
“The research shows that more frequent dosing in those patients [weighing 90kg] or more, has a better response than the standard monthly treatment,” he said.
“It’s great news for patients with moderate to severe plaque psoriasis.”
Secukinumab is a monoclonal antibody that selectively neutralises interleukin (IL)-17A, a cornerstone cytokine in the pathogenesis of psoriatic disease.
It has demonstrated long-lasting efficacy and a favourable safety profile in the various manifestations of psoriatic disease, including skin, nails, scalp, palms, soles and joint, the authors reported.
The standard dosing regimen to achieve and maintain clear or almost clear skin in the overall patient population with moderate-to-severe plaque psoriasis is 300mg of secukinumab every four weeks.
However, as the authors reported, responses to biologics in patients with psoriasis can vary, and some may need individualised therapy.
“One common comorbidity of psoriasis is obesity; over 38% of patients with psoriasis across secukinumab pivotal phase III clinical trials had a bodyweight of > 90 kg,” the authors wrote.
“Body mass index (BMI) can influence response to biologic treatment, with fewer obese patients reaching treatment goals of clear or almost clear skin than nonobese patients.”
The study demonstrated that fortnightly dosing of 300mg of secukinumab led to a clinically and statistically significant advantage in PASI 90 [in Psoriasis Area and Severity Index] response after 16 weeks of treatment compared with standard four-weekly dosing in patients weighing ? 90 kg, and this was maintained until week 52. The treatment was well tolerated for both regimens (fortnightly and monthly).
“These results further support the?use of an alternative treatment regimen for heavier patients with psoriasis (weighing > 90 kg) with the aim of rapidly controlling their disease and achieving PASI 90 responses,” the authors concluded.
A Novartis spokeswoman welcomed the TGA registration of Cosentyx’s individualised dosing “as an important step forward for dermatologists treating heavier weight patients (>90kg) with moderate to severe chronic plaque psoriasis.”
“The ability to offer these heavier patients a more frequent dosing (300mg every 2 weeks during maintenance treatment), gives the treating dermatologist the opportunity to maximise Cosentyx dosing to ensure optimal clinical response in these patients,” she said.
