FDA Label Change Drops Mandatory TB Screening for Risankizumab

The US Food and Drug Administration (FDA) has updated the prescribing information for risankizumab (Skyrizi) so that clinicians can use clinical judgment to decide whether to evaluate patients for tuberculosis (TB) before starting treatment. The change applies to plaque psoriasis, psoriatic arthritis and every other approved indication.¹

The previous label directed clinicians to evaluate all patients for TB infection before starting the interleukin (IL)-23 p19 inhibitor. The revised warnings and precautions section instead advises clinicians to consider TB evaluation before treatment, with the decision guided by clinical judgment.¹

According to AbbVie, a TB test is no longer mandatory before starting risankizumab. The company described the revision as giving clinicians more flexibility in assessing patients before treatment.¹

The update was announced October 23, 2026, alongside FDA approval of a subcutaneous induction regimen for adults with moderately to severely active Crohn’s disease.¹˒² Risankizumab therapy is approved in the US for moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.¹ Because the TB change applies to all 4 indications, it directly affects psoriasis practice.

How Does the Label Change Align With Recent Psoriasis Guidance?

The revision follows a joint position statement from the National Psoriasis Foundation (NPF) Medical Board and the International Psoriasis Council (IPC), published in the Journal of the American Academy of Dermatology.³ The statement concluded that routine testing for latent TB infection isn’t required for patients with psoriasis receiving IL-17 or IL-23 inhibitors, because the evidence supporting it is weak.

The statement’s authors drew on basic science, clinical trial data, real-world evidence and adverse event reports, which together show little risk of TB reactivation with these drug classes.³ About 87.5% of NPF Medical Board and IPC members endorsed the position.

The statement also identified harms of routine testing in this population, including false-positive results, loss to follow-up and unnecessary treatment for latent TB infection.³

When Should Dermatologists Still Consider TB Testing?

Neither the label nor the joint statement eliminates TB evaluation. The NPF and IPC statement notes that testing may still be appropriate for patients living in or coming from regions where TB is endemic and for those receiving other immunosuppressive therapy at the same time.³

The joint statement doesn’t cover ustekinumab, an IL-12/23 inhibitor, or TYK2 inhibitors. Screening requirements for JAK inhibitors and TNF inhibitors are unchanged.³ Clinicians should continue to follow the labeling for each agent.

The revised label doesn’t prohibit testing, so clinicians can still screen any patient whose history, exposures or other therapies raise concern.¹ In HCPLive’s discussion of the joint statement, commentators suggested that FDA label changes for other IL-17 and IL-23 inhibitors could follow.⁴ For now, the risankizumab update gives dermatologists regulatory backing to individualize TB screening decisions for patients with psoriasis and psoriatic arthritis.

Where Did TB Testing Requirements for Psoriasis Biologics Come From?

In an HCPLive Special Report on the joint statement, 2 of its co-authors traced current screening requirements to the era of TNF inhibitors.⁴ They were Andrew Blauvelt, MD, MBA, adjunct professor in the Department of Dermatology at the University of Maryland School of Medicine, and Joseph F. Merola, MD, MMSc, chair of the Department of Dermatology at UT Southwestern Medical Center.

TNF blockade carries a well-established risk of reactivating latent TB, backed by both mechanism and clinical data, but Blauvelt said comparable evidence hasn’t emerged for IL-17 or IL-23 inhibition. Merola pointed to animal models in which TNF-deficient mice die of Mycobacterium tuberculosis infection, while selectively blocking the IL-17 and IL-23 pathways doesn’t appear to weaken the host’s control of the organism.⁴

Merola also described the practical costs of routine testing: added work for practices and patients, higher health care spending and delays in starting treatment.⁴ He noted that testing requirements can give payers grounds to slow access to effective therapy. He has added a reference to the statement to his Epic note templates to support individualized screening decisions.

Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.

References

1. AbbVie. US 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. Accessed November 2, 2026. https://news.abbvie.com/2026-10-23-U-S-FDA-Approves-Subcutaneous-Induction-Regimen-for-AbbVies-SKYRIZI-R-risankizumab-rzaa-for-Adults-With-Moderately-to-Severely-Active-Crohns-Disease

2. Derman C. FDA approves subcutaneous risankizumab induction for Crohn’s disease. HCPLive. Published October 23, 2026. Accessed November 2, 2026. https://www.hcplive.com/view/fda-approves-subcutaneous-risankizumab-crohns-disease.

3. Blauvelt A, Strober BE, Eakin GS, et al. Joint position statement from the National Psoriasis Foundation Medical Board and the International Psoriasis Council on routine testing for latent tuberculosis infection prior to and during treatment of psoriasis patients with interleukin 17 or interleukin 23 inhibitors. J Am Acad Dermatol. 2026;94(3):802-809. doi:10.1016/j.jaad.2025.11.033.

4. HCPLive. TB testing and IL-17, IL-23 inhibitors in psoriasis: a new joint statement. Published October 20, 2026. Accessed November 2, 2026. https://www.hcplive.com/special-report/tb-testing-il-17-il-23-inhibitors-psoriasis-new-joint-statement.