{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T03:41:46Z","timestamp":1793245306379,"version":"4.5.0"},"reference-count":44,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,5,15]],"date-time":"2023-05-15T00:00:00Z","timestamp":1684108800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82104476"],"award-info":[{"award-number":["82104476"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Risankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn\u2019s disease. The real-world safety study of risankizumab in a large- sample population is currently lacking. The aim of this study was to evaluate risankizumab-associated adverse events (AEs) and characterize the clinical priority through the data mining of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Disproportionality analyses were performed by calculating the reporting odds ratios (RORs), deemed significant when the lower limit of the 95% confidence interval was greater than 1, to quantify the signals of risankizumab-related AEs from the second quarter (Q2) of 2019 to 2022 Q3. Serious and non-serious cases were compared, and signals were prioritized using a rating scale.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Risankizumab was recorded in 10,235 reports, with 161 AEs associated with significant disproportionality. Of note, 37 PTs in at least 30 cases were classified as unexpected AEs, which were uncovered in the drug label, such as myocardial infarction, cataract, pancreatitis, diabetes mellitus, stress, and nephrolithiasis. 74.68%, 25.32%, and 0% PTs were graded as weak, moderate, and strong clinical priorities, respectively. A total of 48 risankizumab-related AEs such as pneumonia, cerebrovascular accident, cataract, loss of consciousness, cardiac disorder, hepatic cirrhosis, and thrombosis, were more likely to be reported as serious AEs. The median TTO of moderate and weak signals related to risankizumab was 115 (IQR 16.75\u2013305) and 124 (IQR 29\u2013301) days, respectively. All of the disproportionality signals had early failure type features, indicating that risankizumab-associated AEs gradually decreased over time.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our study found potential new AE signals and provided valuable evidence for clinicians to mitigate the risk of risankizumab-associated AEs based on an extensive analysis of a large-scale postmarketing international safety database.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fimmu.2023.1169735","type":"journal-article","created":{"date-parts":[[2023,5,15]],"date-time":"2023-05-15T13:09:44Z","timestamp":1684156184000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":48,"title":["Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system"],"prefix":"10.3389","volume":"14","author":[{"given":"Yamin","family":"Shu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiling","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qilin","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,5,15]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.07.064","article-title":"Psoriasis and comorbid diseases: epidemiology","volume":"76","author":"Takeshita","year":"2017","journal-title":"J Am Acad Dermatol"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13854","article-title":"A systematic review of worldwide epidemiology of psoriasis","volume":"31","author":"Michalek","year":"2017","journal-title":"J Eur Acad Dermatol Venereol JEADV"},{"key":"B3","article-title":"Prevalence of psoriasis in children and adolescents in the united states: a claims-based analysis","volume":"17","author":"Paller","year":"2018","journal-title":"J Drugs Dermatol JDD"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1159\/000524199","article-title":"Adverse effects of anti-Interleukin-23 agents employed in patients with psoriasis: a systematic review","volume":"238","author":"Naik","year":"2022","journal-title":"Dermatol (Basel Switzerland)"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2017.07.004","article-title":"Psoriasis pathogenesis and the development of novel targeted immune therapies","volume":"140","author":"Hawkes","year":"2017","journal-title":"J Allergy Clin Immunol"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s40257-017-0328-3","article-title":"Choosing first-line biologic treatment for moderate-to-Severe psoriasis: what does the evidence say","volume":"19","author":"Amin","year":"2018","journal-title":"Am J Clin Dermatol"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S167149","article-title":"Risankizumab: an anti-IL-23 antibody for the treatment of psoriasis","volume":"12","author":"Haugh","year":"2018","journal-title":"Drug design Dev Ther"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2021.02.057","article-title":"Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data","volume":"85","author":"Shear","year":"2021","journal-title":"J Am Acad Dermatol"},{"key":"B9","doi-asserted-by":"publisher","first-page":":530","DOI":"10.3390\/ijms19020530","article-title":"Role of the IL-23\/IL-17 axis in psoriasis and psoriatic arthritis: the clinical importance of its divergence in skin and joints","volume":"19","author":"Boutet","year":"2018","journal-title":"Int J Mol Sci"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30263-4","article-title":"Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial","volume":"395","author":"Mease","year":"2020","journal-title":"Lancet (London England)"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31713-6","article-title":"Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials","volume":"392","author":"Gordon","year":"2018","journal-title":"Lancet (London England)"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1111\/apt.17358","article-title":"Effectiveness and safety of risankizumab induction therapy for 100 patients with crohn's disease: a GETAID multicentre cohort study","volume":"57","author":"Fumery","year":"2022","journal-title":"Alimentary Pharmacol Ther"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00467-6","article-title":"Risankizumab as induction therapy for crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials","volume":"399","author":"D'Haens","year":"2022","journal-title":"Lancet (London England)"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.20818","article-title":"Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis","volume":"186","author":"Gordon","year":"2022","journal-title":"Br J Dermatol"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.996179","article-title":"Gastrointestinal adverse events associated with semaglutide: a pharmacovigilance study based on FDA adverse event reporting system","volume":"10","author":"Shu","year":"2022","journal-title":"Front Public Health"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.862508","article-title":"Post-marketing safety concerns with secukinumab: a disproportionality analysis of the FDA adverse event reporting system","volume":"13","author":"Shu","year":"2022","journal-title":"Front Pharmacol"},{"key":"B17","doi-asserted-by":"publisher","first-page":"789","DOI":"10.2147\/CLEP.S365513","article-title":"A real-world disproportionality analysis of olaparib: data mining of the public version of FDA adverse event reporting system","volume":"14","author":"Shu","year":"2022","journal-title":"Clin Epidemiol"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15336","article-title":"Analysis of adverse event of interstitial lung disease in men with prostate cancer receiving hormone therapy using the food and drug administration adverse event reporting system","volume":"89","author":"Wu","year":"2023","journal-title":"Br J Clin Pharmacol"},{"key":"B19","doi-asserted-by":"publisher","first-page":"286","DOI":"10.1186\/s40425-019-0754-2","article-title":"Endocrine toxicity of immune checkpoint inhibitors: a real-world study leveraging US food and drug administration adverse events reporting system","volume":"7","author":"Zhai","year":"2019","journal-title":"J immunother Cancer"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1001","article-title":"The reporting odds ratio and its advantages over the proportional reporting ratio","volume":"13","author":"Rothman","year":"2004","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.849758","article-title":"Neurological adverse events associated with esketamine: a disproportionality analysis for signal detection leveraging the FDA adverse event reporting system","volume":"13","author":"Guo","year":"2022","journal-title":"Front Pharmacol"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1177\/2047487320915663","article-title":"Adverse events with sacubitril\/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system","volume":"28","author":"Gatti","year":"2021","journal-title":"Eur J Prev Cardiol"},{"key":"B23","doi-asserted-by":"publisher","first-page":"106601","DOI":"10.1016\/j.intimp.2020.106601","article-title":"Colitis following the use of immune checkpoint inhibitors: a real-world analysis of spontaneous reports submitted to the FDA adverse event reporting system","volume":"84","author":"Hu","year":"2020","journal-title":"Int Immunopharmacol"},{"key":"B24","doi-asserted-by":"publisher","first-page":"599","DOI":"10.2165\/11599740-000000000-00000","article-title":"A signal detection method to detect adverse drug reactions using a parametric time-to-event model in simulated cohort data","volume":"35","author":"Cornelius","year":"2012","journal-title":"Drug Saf"},{"key":"B25","doi-asserted-by":"publisher","first-page":"995","DOI":"10.1007\/s40264-013-0061-7","article-title":"Illustration of the weibull shape parameter signal detection tool using electronic healthcare record data","volume":"36","author":"Sauzet","year":"2013","journal-title":"Drug Saf"},{"key":"B26","doi-asserted-by":"publisher","first-page":"595","DOI":"10.1007\/s13555-022-00876-x","article-title":"Risankizumab in patients with moderate-to-Severe atopic dermatitis: a phase 2, randomized, double-blind, placebo-controlled study","volume":"13","author":"Tyring","year":"2023","journal-title":"Dermatol Ther"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1007\/s40744-022-00474-5","article-title":"Long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis: results from a 76-week phase 2 randomized trial","volume":"9","author":"Mease","year":"2022","journal-title":"Rheumatol Ther"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15581","article-title":"Potential cerebrovascular accident signal for risankizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS)","author":"Woods","year":"2022","journal-title":"Br J Clin Pharmacol"},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2012.339","article-title":"Global epidemiology of psoriasis: a systematic review of incidence and prevalence","volume":"133","author":"Parisi","year":"2013","journal-title":"J Invest Dermatol"},{"key":"B30","doi-asserted-by":"publisher","first-page":"e13802","DOI":"10.1111\/dth.13802","article-title":"A network meta-analysis for the comparison of efficacy and safety of interleukin (IL)-23 targeted drugs in the treatment of moderate to severe psoriasis","volume":"33","author":"Shi","year":"2020","journal-title":"Dermatologic Ther"},{"key":"B31","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00466-4","article-title":"Risankizumab as maintenance therapy for moderately to severely active crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial","volume":"399","author":"Ferrante","year":"2022","journal-title":"Lancet (London England)"},{"key":"B32","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-221019","article-title":"Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial","volume":"81","author":"Kristensen","year":"2022","journal-title":"Ann rheumatic Dis"},{"key":"B33","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.18029","article-title":"Sustained long-term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double-blind, phase III study","volume":"181","author":"Tha\u00e7i","year":"2019","journal-title":"Br J Dermatol"},{"key":"B34","doi-asserted-by":"publisher","first-page":"890","DOI":"10.1111\/bjd.14964","article-title":"Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials","volume":"176","author":"Rungapiromnan","year":"2017","journal-title":"Br J Dermatol"},{"key":"B35","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2012.04705.x","article-title":"Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open-label extension trial of the interleukin-12\/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis","volume":"27","author":"Langley","year":"2013","journal-title":"J Eur Acad Dermatol Venereol JEADV"},{"key":"B36","article-title":"Safety surveillance for ustekinumab and other psoriasis treatments from the psoriasis longitudinal assessment and registry (PSOLAR) errata","volume":"19","author":"Papp","year":"2020","journal-title":"J Drugs Dermatol JDD"},{"key":"B37","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keac607","article-title":"Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study","author":"Kristensen","year":"2022","journal-title":"Rheumatol (Oxford England)"},{"key":"B38","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2020.0723","article-title":"Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis: a phase 3 randomized clinical trial","volume":"156","author":"Blauvelt","year":"2020","journal-title":"JAMA Dermatol"},{"key":"B39","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1016\/j.jaad.2016.08.008","article-title":"Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: results from the CLEAR study","volume":"76","author":"Blauvelt","year":"2017","journal-title":"J Am Acad Dermatol"},{"key":"B40","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.19039","article-title":"British Association of dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update","volume":"183","author":"Smith","year":"2020","journal-title":"Br J Dermatol"},{"key":"B41","doi-asserted-by":"publisher","first-page":"88","DOI":"10.1002\/cpt.893","article-title":"Anti-IL-23 and anti-IL-17 biologic agents for the treatment of immune-mediated inflammatory conditions","volume":"103","author":"Frieder","year":"2018","journal-title":"Clin Pharmacol Ther"},{"key":"B42","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)30952-3","article-title":"Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial","volume":"394","author":"Reich","year":"2019","journal-title":"Lancet (London England)"},{"key":"B43","unstructured":"SKYRIZI\u00ae (risankizumab-rzaa) injection, for subcutaneous or intravenous use"},{"key":"B44","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcp2108501","article-title":"Latent tuberculosis infection","volume":"385","author":"Shah","year":"2021","journal-title":"New Engl J Med"}],"container-title":["Frontiers in Immunology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2023.1169735\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,15]],"date-time":"2023-05-15T13:09:49Z","timestamp":1684156189000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2023.1169735\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5,15]]},"references-count":44,"alternative-id":["10.3389\/fimmu.2023.1169735"],"URL":"https:\/\/doi.org\/10.3389\/fimmu.2023.1169735","relation":{},"ISSN":["1664-3224"],"issn-type":[{"value":"1664-3224","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,5,15]]},"article-number":"1169735"}}