What are the potential side effects and complications of Risankizumab (generic name) treatment?

Side Effects and Complications of Risankizumab

Risankizumab demonstrates a favorable safety profile with predominantly mild-to-moderate upper respiratory tract infections and no unique or unexpected adverse events compared to other biologics, though serious allergic reactions and infections remain important risks requiring monitoring. 1, 2

Serious Adverse Events Requiring Immediate Action

Serious Allergic Reactions

• Stop risankizumab immediately and seek emergency care if any of the following occur: fainting, dizziness, chest tightness, swelling of face/lips/tongue/throat, skin rash/hives, or difficulty breathing 2
• These reactions are contraindications to continued therapy 2

Infections

Overall Infection Profile:

• Infections occur at a rate of 18.5% with risankizumab versus 6.2% with placebo (relative risk 3.30), primarily driven by non-serious infections 1
• Serious infections occur at 1.2 per 100 patient-years with long-term treatment, comparable to or lower than other biologics 1
• As an IL-23 inhibitor, risankizumab may have lower rates of opportunistic infections compared to TNF antagonists 1

Specific Infection Types:

• Most common: upper respiratory tract infections (mild-to-moderate) 1
• COVID-19 infection reported in 8.6% of patients 3
• Nasopharyngitis in 5.7% of patients 3
• No increased enteric infections compared to placebo 1

When to Hold Therapy:

• Temporarily discontinue risankizumab for febrile illness requiring antibiotics 1
• Treatment can restart after complete infection resolution and antibiotic course completion 1
• Contraindicated in patients with clinically important active infection 1

Risk Factors That Increase Infection Risk

Clinicians must assess these factors before and during treatment:

• Age >65 years increases infection risk with any immunosuppressive therapy 1
• Malnutrition (odds ratio 2.31) and obesity (odds ratio 1.07 per kg/m²) independently increase risk 1
• Active inflammatory disease increases infection risk by 30% per 100-point increase in disease activity scores 1
• Combination therapy with other immunosuppressants dramatically increases risk: odds ratio increases from 2.9 for monotherapy to 14.5 for triple therapy 1

Common Adverse Events in Clinical Trials

Psoriasis Trials

• In the 18-mg and 90-mg risankizumab groups, 12% and 15% respectively had serious adverse events, including two basal-cell carcinomas and one major cardiovascular event 4
• No serious adverse events occurred in the 180-mg group in one phase 2 trial 4
• No new safety signals observed in patients switching from IL-17 inhibitors 3

Inflammatory Bowel Disease Trials

• Adverse event rates were similar between risankizumab and placebo groups in both Crohn's disease and ulcerative colitis trials 5
• Treatment-emergent adverse events were similar among treatment groups in ADVANCE and MOTIVATE trials 5
• No new safety risks detected in ulcerative colitis induction or maintenance trials 6

Mandatory Pre-Treatment Screening

Before initiating risankizumab, perform:

• Tuberculosis testing (latent TB must be treated before starting therapy) 1
• Hepatitis B and C screening 1
• HIV testing based on individual risk factors 1
• Complete blood count and metabolic profile 1

During Treatment:

• Yearly tuberculosis testing in high-risk patients 1
• Monitor for signs/symptoms of infection at each visit 2

Special Population Considerations

Pregnancy and Lactation

• Insufficient data to establish drug-associated risk of major birth defects or miscarriage 2
• Increased fetal/infant loss noted at 50 mg/kg dose in cynomolgus monkeys (43% vs 19% in controls) 2
• Monoclonal antibodies can cross the placenta and may cause immunosuppression in utero-exposed infants 2
• Delay live virus immunizations in exposed infants for at least 5 months after birth due to drug half-life 2
• Unknown if risankizumab passes into breast milk; consider benefits of breastfeeding against potential infant exposure 2

Immunization Considerations

• Avoid live vaccines immediately before, during, or after risankizumab treatment 2
• Risankizumab may interfere with immune response to infections, affecting vaccine efficacy 2
• Inform vaccination providers that patient is receiving risankizumab 2

Drug Interactions

Risankizumab has no clinically significant drug interactions:

• Does not affect CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A enzyme activity 7
• No dose adjustments needed for medications metabolized by these pathways 7
• No potential for drug interactions through cytochrome P450 enzymes 7

Long-Term Safety Data

• Durable safety profile maintained through >2.5 years of continuous exposure in LIMMitless extension study 8
• No unique or unexpected infection patterns emerged compared to other biologics 1
• Long-term safety studies continue to evaluate malignancy risk, though no definitive evidence of increased solid tumor or lymphoreticular malignancy risk with IL-23 inhibitors 5

Clinical Pitfalls to Avoid

• Do not overlook tuberculosis screening - latent TB reactivation is a serious risk with immunosuppression 1
• Do not continue therapy during active serious infections - temporary discontinuation is necessary 1, 2
• Do not combine with multiple immunosuppressants without careful consideration - infection risk increases exponentially 1
• Do not administer live vaccines during or immediately surrounding treatment period 2