FDA Revises TB Evaluation Guidance for SKYRIZI

The US Food and Drug Administration (FDA) has approved an update to the prescribing information for risankizumab-rzaa (SKYRIZI; AbbVie), revising recommendations surrounding tuberculosis (TB) evaluation before treatment initiation.¹

The updated warnings and precautions language applies across all approved indications for risankizumab, including moderate to severe plaque psoriasis and active psoriatic arthritis. Under the revised labeling, health care providers may consider TB evaluation before initiating treatment based on clinical judgment, rather than being directed to routinely evaluate all patients for TB before treatment.¹

According to AbbVie, the change provides clinicians with greater flexibility when assessing patients before initiating risankizumab, with no mandatory TB test required prior to treatment.¹

The update represents a change from previous prescribing information. Earlier US labeling instructed clinicians to evaluate patients for TB infection before initiating risankizumab. The previous labeling also advised clinicians to consider anti-TB therapy before treatment in patients with a history of latent or active TB for whom an adequate course of treatment could not be confirmed, monitor patients for signs and symptoms of active TB during and after treatment, and avoid administering risankizumab to patients with active TB.²

The revised language may have practical implications for dermatology clinicians prescribing risankizumab by allowing TB evaluation to be individualized according to a patient's clinical circumstances rather than treated as a universal pretreatment requirement.

Risankizumab is an interleukin-23 antagonist approved in the US for several immune-mediated inflammatory diseases. In dermatology, the therapy is indicated for adults and pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as adults with active psoriatic arthritis.²

The TB labeling change was announced alongside FDA approval of a subcutaneous induction regimen for risankizumab in adults with moderately to severely active Crohn disease.¹

References

1. AbbVie. U.S. FDA approves subcutaneous induction regimen for AbbVie's SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease. Published October 23, 2026. AbbVie press release
2. US Food and Drug Administration. SKYRIZI (risankizumab-rzaa) prescribing information. Revised June 2026. FDA prescribing information