Therapeutic Indications1
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1
Study designs
FUTURE 5: A randomised, double-blind, Phase III study in patients with active moderate to severe PsA (N=996) randomised to receive Cosentyx 150 mg without loading dose (n=222), Cosentyx 150 mg with loading dose (n=220), Cosentyx 300 mg with loading dose (n=222) or placebo (n=332). The primary endpoint was the percentage of patients with ACR20 response at Week 16.15
FUTURE 1: A multicentre, randomised, double-blind, placebo-controlled, Phase III study in patients with active PsA (N=606) randomised to receive Cosentyx or placebo. Patients in the Cosentyx group received an IV dose of 10 mg/kg of body weight at baseline, Week 2 and Week 4, followed by SC Cosentyx 150 mg or 75 mg every 4 weeks thereafter. The primary endpoint was the percentage of patients with ACR20 response at Week 24.18
Cosentyx is not currently available as an IV treatment.
Please note, Cosentyx should not be used without a loading dose, and the Cosentyx 75 mg dose is not licensed for PsA. The recommended dose for TNFi-IR is 300 mg by SC injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. For other patients, the recommended dose is 150 mg by SC injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, this can be increased to 300 mg.1
Cosentyx has not been studied in renal/hepatically impaired patient populations. No dose recommendations can be made.1
For patients with concomitant moderate to severe PsO, please refer to adult PsO recommendations in the Cosentyx SmPC.1
ACR, American College of Rheumatology; AS, ankylosing spondylitis; BSA, body surface area; BSR, British Society for Rheumatology; ERA, enthesitis-related arthritis; EULAR, European Alliance of Associations for Rheumatology; HAQ-DI, health assessment questionnaire-disability index; HS, hidradenitis suppurativa; IR, inadequate responder; IV, intravenous; JPsA, juvenile psoriatic arthritis; MDA, minimal disease activity; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; SC, subcutaneous; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor; VAS, visual analogue scale.
References
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