PracticeUpdate Dermatology May 2019

Are you targeting complete treatment for your psoriasis patients? * *Efficacy of Cosentyx established by achievement of primary endpoints in clinical trials looking at manifestations of psoriatic disease (skin, joint, spine, nail, scalp and palmoplantar) 1–8

Sustained clear skin with 90% of PASI responses maintained over 5 years 8,9 No new safety signals up to 5 years 8,9

COSENTYX ® (secukinumab) Indication: Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Treatment of adult patients with active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Treatment of adult patients with active ankylosing spondylitis. Dosage and administration: Plaque psoriasis: The recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by the same dose every month . Each 300 mg dose is given as two subcutaneous injections of 150 mg. Psoriatic arthritis: The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by the same dose every month . For patients who are anti-TNF α inadequate responders or patients with concomitant moderate to severe plaque psoriasis, the recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by the same dose every month . Each 300 mg dose is given as two subcutaneous injections of 150 mg. Ankylosing spondylitis: The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by the same dose every month . Contraindications: Severe hypersensitivity reactions to the active substance or to any of the excipients. Clinically important, active infections. Precautions: Infections: Caution in patients with chronic or history of recurrent infection. If a patient develops a serious infection, the patient should be closely monitored and Cosentyx should not be administered until the infection resolves. Anti-tuberculosis therapy should be considered prior to initiation in patients with latent tuberculosis. Cosentyx should not be given to patients with active tuberculosis. Crohn’s disease: Caution should be exercised, when prescribing to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred during clinical trials in plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials. Patients should be monitored for signs and symptoms of inflammatory bowel disease. Hypersensitivity reactions: Rare cases of anaphylactic reactions have been observed during clinical trials.Administration should be discontinued immediately and appropriate therapy initiated if an anaphylactic or other serious allergic reaction occurs. Latex-sensitive individuals: The removable cap of the Cosentyx prefilled syringes/pen contains a derivative of natural rubber latex. Vaccinations: Cosentyx should not be given concurrently with live vaccines. Pregnancy: Cosentyx should be used during pregnancy only if the benefits clearly outweigh the potential risks. Lactation: Caution should be exercised when Cosentyx is administered to a woman who is breast-feeding. Interactions: Live vaccines should not be given concurrently with Cosentyx. In a study in subjects with plaque psoriasis, no clinically relevant pharmacokinetic interaction was observed between secukinumab and midazolam (CYP3A4 substrate) . Side effects: Very common (≥10%): nasopharyngitis. Common (≥1 to ≤10%): upper respiratory tract infection, rhinitis, pharyngitis, oral herpes, diarrhoea, urticaria, rhinorrhoea, headache, nausea, hypercholesterolemia. Uncommon (≥0.1 to ≥1%): sinusitis, tonsillitis, oral candidiasis, neutropenia, tinea pedis, otitis externa, conjunctivitis. Frequency not known: mucosal and cutaneous candidiasis. In clinical trials, major adverse cardiovascular events were rarely observed in patients receiving secukinumab. In the overall secukinumab program, the exposure adjusted incidence rates of adjudication-confirmed cases per 100 patient-years for secukinumab was 0.40 versus 0.39 for placebo. Elevations (mainly CTCAE Grade 1 and Grade 2) in cholesterol, triglycerides and hepatic transaminases were also observed during clinical trials in patients with psoriatic arthritis and ankylosing spondylitis. ( cos140518m) . Abbreviation: PASI: Psoriasis Area and Severity Index. References: 1 . McInnes IB et al. Lancet 2015;386:1137–46. 2. Bagel J et al. J Am Acad Dermatol 2017;77(4):667–74. 3. Langley RG et al. N Engl J Med 2014;371(4):326–38. 4. Reich K et al. EADV 2016; Vienna, Austria (Poster 2095). 5. Gottlieb A et al. J Am Acad Dermatol 2017;76(1):70–80. 6. Blauvelt A et al. J Am Acad Dermatol 2015;76(1):60–9. 7. Cosentyx Approved Product Information. 8. Bissonnette R et al. Br J Dermatol 2017;177:1033–42. 9. Bissonnette R et al. J Eur Acad Dermatol Venereol 2018;32:1507–14. Cosentyx is a registered trademark of Novartis AG. Novartis Pharmaceuticals Australia Pty Limited. ABN 18 004 244 160. 54 Waterloo Road, Macquarie Park NSW 2113. Ph (02) 9805 3555. April 2019. AU-8989. NODE15897W. See approved Product Information before prescribing. Approved Product Information available on request. For the most up-to-date Product Information, go to: https://www.novartis.com.au/products/healthcare-professionals PBS Information: Section 85 Authority required for the treatment of severe chronic plaque psoriasis, active ankylosing spondylitis and severe psoriatic arthritis. Refer to PBS Schedule for full Authority information.