In January 2015, the US Food and Drug Administration (FDA) approved secukinumab (Cosentyx™, Novartis, USA) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body, eg methotrexate, acitretin or ciclosporin) or phototherapy (light therapy).
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for secukinumab. It was classified as prescription medicine by Medsafe New Zealand in August 2015.
Secukinumab is very effective in the treatment of severe psoriasis and acts fast. It appears very safe. However, only small numbers of patients have been treated to date (March 2015).
How does secukinumab work?
- IL-17A is a key cytokine (messenger protein) involved in the development of plaque psoriasis, and is found in high concentrations in psoriasis plaques.
- Secukinumab is a human IgG1 monoclonal antibody that selectively binds to interleukin-17A (IL-17A) inhibiting its pro-inflammatory effects.
How is secukinumab administered?
- Secukinumab should be kept refrigerated at 2–8 C until shortly before injection. It should not be frozen. Do not shake the bottle.
- Secukinumab is injected subcutaneously in one of three forms: a lyophilized powder formulation for reconstitution and a liquid formulation administered by either a prefilled syringe or Sensoready® autoinjector pen.
- The recommended dose is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks.
- For some patients, a dose of 150 mg may be acceptable.
- Secukinumab is intended for use under the guidance and supervision of a physician.
- Patients may self-inject after proper training in subcutaneous injection technique using the Sensoready pen or prefilled syringe.
- The lyophilized powder for reconstitution is for healthcare provider use only.
- Each injection is administered at a different anatomic location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis.
- Renal impairment: no studies have been conducted.
- Hepatic impairment: no studies have been conducted.
Warnings and precautions
- Caution should be exercised when considering the use of secukinumab in patients with a chronic infection or a history of recurrent infection.
- Secukinumab may increase the risk of infections, particularly candida infections.
- In clinical trials, a higher rate of infections was observed in secukinumab-treated patients compared to placebo-treated patients.
- If a serious infection develops, secukinumab should be discontinued until the infection resolves.
- Patients receiving secukinumab should be monitored closely for signs and symptoms of active tuberculosis (TB) during and after treatment.
- If indicated, testing and treatment of latent TB should be initiated prior to administering secukinumab.
- Exacerbations of Crohn disease has been observed in clinical trials with secukinumab.
- Caution should be exercised when prescribing secukinumab to patients with active Crohn disease.
- Patients who are treated with secukinumab and have active Crohn disease should be monitored closely.
- The Sensoready pen and the prefilled syringe have latex rubber stoppers and should not be used by patients allergic to latex.
- Anaphylaxis and cases of urticaria have occurred in secukinumab-treated patients in clinical trials.
- If an anaphylactic or other serious allergic reaction occurs, administration of secukinumab should be discontinued immediately and appropriate therapy initiated.
- Non-live vaccinations received during a course of secukinumab may not elicit an immune response sufficient to prevent disease.
- Patients treated with secukinumab should not receive live vaccines.
Potential drug interactions with secukinumab
- No formal pharmacokinetic drug-drug interaction studies have been conducted with secukinumab.
- Upon initiation or discontinuation of secukinumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, the therapeutic effect of the drug should be monitored (e.g. for warfarin) or drug concentration (e.g. for ciclosporin) and the dose of the CYP450 substrate should be modified.
What are the adverse effects of secukinumab?
In clinical trials the following adverse events have been observed at an incidence >2%:
- nasopharyngitis (11.4%)
- diarrhoea (4.1%)
- upper respiratory tract infection (2.5%)
- candida infections (2.1%)
Use of secukinumab in pregnancy
- There are no adequate and well controlled trials of secukinumab in pregnant women.
- Developmental toxicity studies conducted with monkeys have found no evidence of harm to the fetus due to secukinumab.
- Secukinumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use of secukinumab in nursing mothers
- It is not known whether secukinumab or its metabolites are present in human milk.
- Women should be advised to discontinue breastfeeding during treatment.
Paediatric use of secukinumab
- The safety and effectiveness of secukinumab has not been established in children.
Geriatric use of secukinumab
- Of the 3430 plaque psoriasis subjects exposed to secukinumba in clinical trials, a total of 230 were 65 years or older, and 32 subjects were 75 years or older.
- No differences in safety or efficacy were observed between older and younger subjects.