Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis

Pooled Analysis of Three Randomized Controlled Trials

A. Blauvelt; K. Reich; K.A. Papp; A.B. Kimball; M. Gooderham; S.K. Tyring; R. Sinclair; D. Thaçi; Q. Li; N. Cichanowitz; S. Green; C. La Rosa


The British Journal of Dermatology. 2018;179(3):615-622. 

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Additional patient selection criteria

In P05495 and reSURFACE 1 and 2, patients with a positive tuberculosis (TB) test, or who had signs or symptoms of active TB, or who had had recent close contact with a person with active TB had to have a negative chest radiograph or chest computed tomography that indicated no evidence of current active TB or old inactive TB within 4 weeks before the start of study medication. A patient with latent TB could have been included if they initiated or completed prophylactic treatment for latent TB at least 4 weeks before the start of study medication without subsequent new exposure to active TB. Patients with a positive HIV, HBsAg, or HCV test result, or with any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks before screening, or severe infection requiring hospitalization or treatment with intravenous antibiotics within 8 weeks before screening were excluded. Additional exclusion criteria were prior malignancy or concurrent malignancy, receipt of live viral or bacterial vaccination within 4 weeks before baseline, uncontrolled hypertension (systolic blood pressure of ≥160 mm Hg and/or diastolic blood pressure of ≥100 mm Hg at screening), uncontrolled diabetes, and hospitalization due to an acute cardiovascular (CV) event, CV illness, or CV surgery within 6 months of screening.