Jamteki

For the treatment of *severe plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**.

Claims for the first 6 months must be written by a dermatologist.

Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required.

Patients not responding adequately at 12 weeks should have treatment discontinued.

*Definition of severe plaque psoriasis:

• Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND

• Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND

• Dermatology Life Quality Index (DLQI) score of at least 10.

**Definition of failure, intolerance or contraindication to adequate trials of standard therapies:

• 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND

• 12 week trial of phototherapy (unless not accessible); AND

• 6 month trial of at least 2 systemic, oral agents used alone or in combination
  - Methotrexate 15-30mg per week
  - Acitretin (could have been used with phototherapy)
  - Cyclosporine

Maintenance/Renewal:

After 3 months of therapy, patients who respond to therapy should have:

• At least a 50% reduction in PASI, AND

• at least a 50% reduction in BSA involvement, AND

• at least a 5 point reduction in DLQI score

Recommended dose:

The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter.

Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients.

For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks.

If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.

For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite:

i) treatment with methotrexate (20mg/week) for at least 3 months; AND

ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.

If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required.

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.

The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg.

Ustekinumab may be used alone or in combination with methotrexate (MTX).