Adapted from Papp K, et al. 2022.
AE, adverse event; E, events; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PYs, patient-years; RZB, risankizumab; TEAE, treatment-emergent AE.
aPrimary psoriasis safety pool includes UltIMMa-1,3 UltMMa-2,3 IMMhance,4 and IMMvent,7 and NCT0205448110 studies.
bDue to natural causes (n = 1), accident (n = 1), cardiovascular event (n = 1), cardiac arrest (n = 1), sudden cardiac death (n = 1), cause unknown (n = 2), and COVID-19 infection (n = 1); none related to RZB.
cMACE rate in the LIMMitless study is consistent with the incidence rate of MACE in the Psoriasis Longitudinal Assessment and Registry (PSOLAR; 0.57 E/100PY; 95% CI, 0.50–0.65).11
dMalignancies were adenocarcinoma of colon (n = 1), basal cell carcinoma (n = 10), bladder cancer (n = 1), Bowen’s disease (n = 1), breast cancer (n = 3), colon cancer (n = 1), colorectal adenocarcinoma (n = 2), endometrial cancer (n = 1), gastric cancer (n = 1), invasive breast carcinoma (n = 1), lentigo maligna (n = 1), malignant melanoma in situ (n = 2), metastatic colon cancer (n = 1), metastatic squamous cell carcinoma (n = 1), papillary urothelial carcinoma (n = 1), prostate cancer (n = 2), rectal cancer (n = 1), squamous cell carcinoma (n = 3), squamous cell carcinoma of the skin (n = 3).
eSerious hypersensitivity reactions (all of which were considered unrelated to study drug) were paraphenylenediamine allergy (n = 1; mild, attributed to hair dye application), generalized microbial eczema (n = 1; moderate, attributed to prolonged duration of generalized eczema and lack of response to treatment with hydrocortisone), and Stevens-Johnson syndrome (n = 1; severe, attributed to addition of chlorpromazine).