Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

Subrata Ghosh (), Lianne S. Gensler (), Zijiang Yang (), Chris Gasink (), Soumya D. Chakravarty (), Kamyar Farahi (), Paraneedharan Ramachandran (), Elyssa Ott () and Bruce E. Strober ()
Additional contact information
Subrata Ghosh: University of Birmingham
Lianne S. Gensler: University of California San Francisco
Zijiang Yang: Janssen Research & Development, LLC
Chris Gasink: Janssen Scientific Affairs, LLC
Soumya D. Chakravarty: Janssen Scientific Affairs, LLC
Kamyar Farahi: Janssen Scientific Affairs, LLC
Paraneedharan Ramachandran: Janssen Research & Development, LLC
Elyssa Ott: Janssen Scientific Affairs, LLC
Bruce E. Strober: University of Connecticut Health Center

Drug Safety, 2019, vol. 42, issue 6, No 7, 768 pages

Abstract: Abstract Introduction Theoretical risks of biologic agents remain under study. Objective The aim of this study was to integrate 1-year safety data from 12 ustekinumab registrational trials. Methods Patients had moderate-to-severe plaque psoriasis, active psoriatic arthritis (PsA) (± methotrexate), or moderate-to-severe Crohn’s disease (CD; failed/intolerant of immunomodulators/corticosteroids). Psoriatic patients received subcutaneous ustekinumab 45/90 mg or placebo, generally at week 0, week 4, then every 12 weeks thereafter, while those with CD received a single intravenous ustekinumab dose (130 mg or weight range-based dosing of approximately 6 mg/kg) or placebo induction dose at week 0, followed by subcutaneous ustekinumab 90 mg at week 8 and every 8/12 weeks thereafter. The incidence rates of a priori-defined safety events were integrated post hoc (adjusted for duration of follow-up, reported per 100 patient-years [PYs]). Results Among 6280 enrolled patients, 5884 ustekinumab-treated patients (psoriasis: 3117; PsA: 1018; CD: 1749) contributed 4521 PYs versus 674 PYs in placebo-treated patients through year 1 (829 PYs and 385 PYs during 8- to 16-week controlled periods). Combined across diseases among ustekinumab- versus placebo-treated patients, respective incidences/100 PYs (95% confidence intervals) of infections were 125.4 (122.2–128.7) versus 129.4 (120.9–138.3) through year 1, and not meaningfully increased in patients who did versus those who did not receive methotrexate (92.5 [84.2–101.5] vs. 115.3 [109.9–121.0]), or significantly increased in patients who did versus those who did not receive corticosteroids (116.3 [107.3–125.9] vs. 107.3 [102.0–112.8]) at baseline. Major adverse cardiovascular events (0.5 [0.3–0.7] vs. 0.3 [0.0–1.1]), malignancies (0.4 [0.2–0.6] vs. 0.2 [0.0–0.8]), and deaths (0.1 [0.0–0.3] vs. 0.0 [0.0–0.4]) were rare across indications. Conclusions Ustekinumab demonstrated a favorable and consistent safety profile across registrational trials in approved indications. Trial Registrations ClinicalTrials.gov identifier: NCT00320216, NCT00267969, NCT00307437, NCT00454584, NCT00267956, NCT01009086, NCT01077362, NCT00265122, NCT00771667, NCT01369329, NCT01369342, and NCT01369355.

Date: 2019
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DOI: 10.1007/s40264-019-00797-3

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