Risankizumab and Lymphadenopathy: No Established Relationship
Lymphadenopathy is not listed as an adverse reaction associated with risankizumab (Skyrizi) in the FDA labeling, and there is no documented relationship between this medication and lymph node enlargement. 1
Key Safety Data from Clinical Trials
The comprehensive FDA safety data for risankizumab across multiple indications (plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis) does not identify lymphadenopathy as an adverse reaction occurring at ≥3% or at rates higher than placebo. 1
Most Common Adverse Reactions (≥3%)
The documented adverse reactions in controlled trials include:
- Arthralgia (5.3-9.6% vs 4.6% placebo in UC maintenance) 1
- Pyrexia (4.0-4.7% vs 3.5% placebo) 1
- Injection site reactions (2.8-2.9% vs 1.2% placebo) 1
- Rash (0.6-4.1% vs 1.7% placebo) 1
Postmarketing Surveillance
The postmarketing experience section, which captures rare adverse events reported after approval, lists only eczema and rash as skin/subcutaneous tissue disorders—lymphadenopathy is notably absent. 1
Mechanism of Action Context
Risankizumab selectively inhibits IL-23 by binding to its p19 subunit, blocking downstream inflammatory signaling. 2, 3 This targeted mechanism has not been associated with lymphoproliferative effects or lymph node pathology in clinical development programs spanning multiple inflammatory conditions. 2
Important Distinction from Other Biologics
While the 2019 AAD-NPF guidelines note that IL-17 inhibitors show no definitive evidence of increased lymphoreticular malignancy risk, 4 risankizumab's IL-23 inhibition represents a different mechanism with similarly favorable safety profiles regarding lymphoid tissue. 5, 6
Clinical Implications
If lymphadenopathy develops in a patient receiving risankizumab, investigate alternative etiologies rather than attributing it to the medication. Consider:
- Underlying inflammatory disease activity
- Concurrent infections (though serious infection rates with risankizumab are similar to placebo) 1
- Unrelated malignancy
- Other medications or comorbidities
The extensive clinical trial experience across psoriasis, psoriatic arthritis, and inflammatory bowel disease, including long-term extension studies exceeding 2.5 years, has not revealed lymphadenopathy as a treatment-emergent concern. 3, 6