In 52 global controlled and uncontrolled clinical trials in RA, PsA, AS, CD, UC, Ps, HS and UV that included 24,605 Humira-treated patients, the rate of reported active tuberculosis was per 100 patient-years and the rate of positive PPD conversion was per 100 patient-years. In a subgroup of 10,113 . and Canadian Humira-treated patients, the rate of reported active TB was per 100 patient-years and the rate of positive PPD conversion was per 100 patient-years. These trials included reports of miliary, lymphatic, peritoneal, and pulmonary TB. Most of the TB cases occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease. In these global clinical trials, cases of serious opportunistic infections have been reported at an overall rate of per 100 patient-years. Some cases of serious opportunistic infections and TB have been fatal [see Warnings and Precautions () ].
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