Data added to the labeling includes first-of-their-kind pharmacokinetic studies demonstrating negligible to low transfer of CIMZIA through placenta and minimal transfer to breast milk from mother to infant.
Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.
The FDA's expanded approvals were supported by data from two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies (GO-VIBRANT and GO-ALIVE) that included >600 patients.
The expanded approval was supported by data from a Phase 3 study that evaluated the safety and efficacy of subcutaneous Stelara in adolescents aged ≥12 years.
Researchers used claims data between 2004-2015 from a large commercial database to identify patients with psoriatic arthritis who were initiated on DMARDs.
The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.
While rare, cases of arthritis associated with bee and wasp stings have been previously reported in the medical literature.