Risankizumab

Name

Skyrizi® Risankizumab

Manufacturer

AbbVie AG

Mechanism of action

Humanized monoclonal IgG1 antibody that binds to and blocks IL-23p19

Authorization in dermatology

Moderate to severe plaque psoriasis in patients 18 years of age and older.

Psoriatic arthritis in adults.

SVK coverage

Yes

Limitation for reimbursement

Treatment of adult patients with severe plaque psoriasis in whom UVB and PUVA, cyclosporine, methotrexate, or acitretin have not been effective.

For active psoriatic arthritis as monotherapy or in combination with csDMARDs in patients who have had an inadequate response to or are intolerant of prior therapy with csDMARDs.

Dosage form

Pre-filled syringe, pre-filled pen

Before starting therapy

Complete blood count (CBC), liver enzymes, creatinine, CRP, screening for HBV, HCV, HIV, and TB (optional: including chest X-ray), urinalysis, pregnancy test, vaccination status.

Monitoring laboratory parameters

No laboratory tests are necessary.

Inspection Intervals

PASI every 6 months.

Administration

s.c.

Dosage

150 mg: weeks 0 and 4, then every 12 weeks;(no dose adjustment required for patients over 65 years of age, those with renal or hepatic impairment, or those who are overweight).

ø Time to Onset of Effect (PASI 90)

Discontinuation of treatment if no improvement is seen after 16 weeks.

PASI75

Week 12: 87.8%, Week 52: 91.7%

(UltIMMa-1 + UltIMMa-2)

PASI90

Week 16: 75%, Week 52: 81%

(UltIMMa-1 + UltIMMa-2)

Caution

No injections for at least 4 weeks after a live vaccine, and no injections for at least 21 weeks after the last dose.

Cost per year in CHF (first year including induction phase)

14,488 (18,110)

Interruption

Median time to sPGA 0/1 loss: 42 weeks. After an interruption, 83.7% return to sPGA 0/1 within 16 weeks.

PASI, BSA, and DLQI after 16 weeks.

Clinical evaluation

PASI, BSA, and DLQI at 16 and 28 weeks.

Development of Anti-Product Antibodies

Antibody formation against risankizumab was observed in 24% of patients, and neutralizing antibodies in 14%; neither had any impact on efficacy or safety.

Contraindications

Absolute contraindications: Clinically significant active infections

Relative contraindications: Acute, recurrent, or chronic infections; pregnancy/breastfeeding

Adverse drug reactions

Upper respiratory tract infections (13%), tinea, headaches, folliculitis.

Use in HBV infection

Insufficient data.

Use in HCV infection

Insufficient data.

Use in HIV infection

Insufficient data.

Interactions

None known; avoid live vaccines.

Use in latent TB infection

Start TB prophylaxis at least 1 month before beginning treatment.

Use in planned surgery

Limited data available. Surgery should be performed between the two doses, if possible.

Cancer risk

No increased risk has been identified to date.