Updates and Insights on Risankizumab for Psoriatic Disease
The US Food and Drug Administration has announced approval of risankizumab-rzaa for the treatment of active psoriatic arthritis (PsA) in adult patients.1 Risankizumab-rzaa is the only interleukin (IL)-23 inhibitor approved for adults with moderate to severe plaque psoriasis and active PsA that can be administered with a single injection 4 times a year after 2 starter doses at weeks 0 and 4.
In this exclusive interview with The Dermatologist, Saakshi Khattri, MD, discusses what this approval means for clinicians and the psoriatic disease community. Dr Khattri is a board-certified dermatologist and rheumatologist and director of the Center to Treat Connective Tissue Diseases at Mount Sinai in New York, NY. She has been involved in research on psoriasis and PsA, including clinical trials for both conditions.
The Dermatologist: How can the durability of risankizumab affect the quality of life among patients with psoriasis and PsA?
Dr Khattri: Risankizumab’s data demonstrates durable Psoriasis Area and Severity Index (PASI) 90 response rates in adults with moderate to severe plaque psoriasis through 3 years of follow up in the open label LIMMitless study.2 PASI 90 is a coprimary end point in the pivotal trials for moderate to severe plaque psoriasis. Risankizumab is now approved for both moderate to severe plaque psoriasis and active PsA—both of which can affect quality of life.
Additionally, pain associated with active PsA significantly impacts quality of life for patients as was noted in a 2019 study of patients with PsA, where it was reported that pain reduction was ranked as the primary treatment goal for patients with PsA.3 In the 2 KEEPsAKE trials, risankizumab achieved the primary end point of the American College of Rheumatology 20% improvement criteria (ACR20) response at week 24 compared with placebo, in addition to showing improvement in other key manifestations of PsA. Pain is a component of the ACR20 response.
The Dermatologist: How does risankizumab compare with other biologics, such as IL-17A inhibitors (eg, secukinumab)?
Dr Khattri: Currently, there are no head-to-head trials between risankizumab and IL-17A inhibitors in PsA, so we cannot draw any conclusions. However, we do know that risankizumab is the only IL-23 inhibitor with a quarterly dosing schedule after starter doses at week 0 and week 4. Risankizumab provides robust ACR20 data at week 24, in addition to data for enthesitis and dactylitis all while showing great PASI 90 response.
The Dermatologist: Are there adverse effects that dermatologists should be aware of and monitor their patients for when using risankizumab?
Dr Khattri: The safety profile observed in patients with PsA treated with risankizumab is generally consistent with the safety profile in patients with plaque psoriasis. When treating patients with risankizumab, dermatologists should be aware of potential adverse hypersensitivity reactions, which are noted in the medication package insert.
Liver function elevation was noted in PsA trials. Besides a pretreatment evaluation for tuberculosis, risankizumab requires no additional laboratory test monitoring and has no label warnings or precautions for malignancy, inflammatory bowel disease, depression, or candidiasis. This is positive news for patients who may be concerned about potential adverse effects.
The Dermatologist: Do you want to share any further insights regarding the management of psoriatic disease or risankizumab-rzaa?
Dr Khattri: One-third of patients with psoriasis also have PsA. Despite this overlap, there remains a delay in diagnosis and treatment of PsA, which can translate to poorer radiographic and functional outcomes. As a practicing dermatologist and rheumatologist, it is helpful to have another treatment option for my patients with active PsA—especially with robust data across ACR20 and other domains like enthesitis and dactylitis and a quarterly dosing schedule for patients compared with more frequent injections.
References
1. US FDA approves second indication for SKYRIZI® (risankizumab-rzaa) to treat adults with active psoriatic arthritis. News release. Abbvie. January 21, 2022. Accessed January 28, 2022. https://news.abbvie.com/news/press-releases/us-fda-approves-second-indication-for-skyrizi-risankizumab-rzaa-to-treat-adults-with-active-psoriatic-arthritis.htm
2. Papp, KA, Lebwohl MG, Puig L, et al. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up. Br J Dermatol. 2021;185(6):1135-1145. doi: 10.1111/bjd.20595
3. Ogdie A, Elaine Husni M, Bush K, et al. AB0769 patient identified treatment goals in psoriatic arthritis: decreasing pain and increasing activity level are high priorities. Paper presented at: Annual European Congress of Rheumatology; June 12-15, 2019; Madrid, Spain. Accessed February 9, 2022. https://ard.bmj.com/content/78/ Suppl_2/1853
