What are the potential side effects of SKYRIZI (Risankizumab) in a patient with moderate to severe plaque psoriasis or psoriatic arthritis?

SKYRIZI Side Effects

SKYRIZI (risankizumab) is generally well-tolerated with upper respiratory infections being the most common side effect, occurring in 13% of patients, followed by headache (3.5%), fatigue (2.5%), and injection site reactions (1.5%). 1

Most Common Side Effects (≥1% incidence)

Based on pooled clinical trial data through 16 weeks in plaque psoriasis patients:

• Upper respiratory infections: 13.0% (includes respiratory tract infections, sinusitis, rhinitis, nasopharyngitis, pharyngitis, tonsillitis) 1
• Headache: 3.5% (includes tension headache, sinus headache, cervicogenic headache) 1
• Fatigue: 2.5% (includes asthenia) 1
• Injection site reactions: 1.5% (includes bruising, erythema, hematoma, pain, pruritus, swelling) 1
• Tinea infections: 1.1% (includes tinea pedis, cruris, versicolor, onychomycosis) 1

Less Common Side Effects (<1% but >0.1%)

• Folliculitis 1
• Urticaria 1

Serious Side Effects Requiring Immediate Medical Attention

Serious Allergic Reactions (Anaphylaxis)

Stop SKYRIZI immediately and seek emergency care if you experience: 1

• Fainting, dizziness, lightheadedness (low blood pressure) 1
• Chest tightness 1
• Swelling of face, eyelids, lips, mouth, tongue, or throat 1
• Skin rash or hives 1
• Trouble breathing or throat tightness 1
• One case of anaphylaxis was reported in phase 2 trials 1

Infections

SKYRIZI lowers immune system function and increases infection risk: 1

• Overall infection rate: 22.1% in first 16 weeks (vs 14.7% placebo) 1
• Serious infections: ≤0.4% (including cellulitis, osteomyelitis, sepsis, herpes zoster) 1
• Through 52 weeks, one case of pneumonia led to discontinuation 1
• Contact your provider immediately for: fever, sweats, chills, muscle aches, weight loss, cough, warm/red/painful skin sores, diarrhea, stomach pain, shortness of breath, burning with urination, or blood in mucus 1

Tuberculosis Risk

• Screening for TB is mandatory before starting SKYRIZI 1
• Treatment for latent TB may be required before initiating SKYRIZI 1
• Close monitoring for TB symptoms is required during and after treatment 1

Psoriatic Arthritis-Specific Side Effects

In psoriatic arthritis trials, additional findings included: 1

Hepatic Events

• Incidence: 5.4% in SKYRIZI group vs 3.9% placebo 1
• ALT elevation: 2.3% (vs 1.7% placebo) 1
• AST elevation: 1.8% (vs 1.3% placebo) 1
• GGT elevation: 1.1% (vs 0.7% placebo) 1
• No serious hepatic events were reported 1

Hypersensitivity Reactions

• Incidence: 2.3% in SKYRIZI group vs 1.3% placebo 1
• Includes rash (0.7%), allergic rhinitis (0.3%), and facial swelling (0.1%) 1

Long-Term Safety (Through 52 Weeks)

• No new adverse reactions identified beyond 16 weeks 1
• Infection rate remained stable at 73.9 events per 100 subject-years 1
• Serious infections requiring discontinuation included pneumonia 1

Important Safety Considerations

Contraindications

• Absolute: Known hypersensitivity to risankizumab or any ingredient 1
• Relative: Active infections, recurrent infections, active or latent TB 1

Vaccination Precautions

• Avoid live vaccines immediately before, during, or after SKYRIZI treatment 1
• Inform healthcare providers about SKYRIZI use before any vaccination 1

Pregnancy and Breastfeeding

• Unknown if SKYRIZI harms unborn babies 1
• Unknown if SKYRIZI passes into breast milk 1
• Pregnancy registry available (call 1-877-302-2161) 1

Comparison to Other Biologics

While not specific to risankizumab, IL-12/23 inhibitors like ustekinumab show favorable safety profiles compared to TNF antagonists: 2

• Lower serious infection rates (0.93/100 patient-years for ustekinumab vs 1.9-2.9/100 patient-years for anti-TNF) 2
• Most common events with IL-12/23 inhibitors: respiratory tract infections, nasopharyngitis, headache, injection site reactions 2