Safety
hypoadrenalism, death, deterioration of hepatic function, ischemic heart failure, kidney calculus, pain, rash, Alcoholic liver disorder, scirrhous gastric cancer
DISORDER, HYPOADRENALISM, ERYTHRODERMIC PSORIASIS, ADVERSE EVENTS, INFLAMMATION, URINARY CALCULUS, ADVERSE EVENT, GENERALIZED PUSTULAR PSORIASIS, ALCOHOLIC LIVER DISORDER, URINARY TRACT INFECTION
Treatment‐emergent AEs were reported for most (88.2%) patients (Table Safety overview of risankizumab in Japanese patients with GPP or EPAbbreviations: AE, adverse event; EP, erythrodermic psoriasis; GPP, generalized pustular psoriasis; TEAE, treatment‐emergent adverse event.As assessed by the study investigator.Patient with scirrhous gastric cancer on day 113 that led to study drug discontinuation; considered not related to study drug.Alcoholic liver disorder on day 183; considered not related to study drug (related to heavy use of alcohol) and did not interrupt study drug.Patient had two serious adverse events (AEs; urinary tract infection [day 296] and hypoadrenalism [day 307]); both were considered not related to study drug, did not interrupt study drug, and resolved within 11 and 5 days, respectively.Urinary calculus on day 384; considered not related to study drug (related to preexisting kidney calculus) and resolved by day 433.Nonserious AE of inflammation, pain in extremity, and rash on day 1; considered not related to study drug.Serious AE of ischemic heart failure leading to death on day 675; considered not related to study drug.Nonserious elevation in liver enzymes; resolved 64 days later and did not lead to study drug disruption.Nonserious aggravation of hepatic function disorder on day 85; considered not related to study drug and did not lead to study drug interruption; concomitant medications were discontinued.Nonserious deterioration of hepatic function on day 86; considered not related to study drug and did not lead to study drug interruption.Nonserious elevation in total bilirubin; resolved 176 days later and did not lead to study drug interruption.