Respuesta :
OBJECTIVES: To evaluate the safety of guselkumab (anti-interleukin [IL]-23p19 monoclonal antibody) in patients with psoriatic arthritis (PsA) through one year (1Y) of the phase III DISCOVER-1 and DISCOVER-2 trials.
METHODS: Patients with active PsA (n=1120; biologic naïve except for 118 patients with DISCOVER-1 who were treated with tumor necrosis factor inhibitors) were randomized to guselkumab 100 mg subcutaneously. were assigned every 4 weeks (Q4W) or week 0 and then every 4 weeks. 8 weeks (Q8W); or placebo. At week 24, the patient in the placebo group switched her to guselkumab 100 mg every 4 weeks.
result: Through week 24, adverse events (AEs) were consistent between placebo and guselkumab. No uveitis, active tuberculosis, opportunistic infections, or inflammatory bowel disease were observed in the guselkumab-treated patient for 1 year, a low rate of malignancy and serious cardiovascular (CV) adverse events. was observed. Injection site reactions occurred in 1.7% and antibodies to guselkumab occurred in her 4.5% of patients treated with guselkumab for her 1 year.
Conclusion: Guselkumab 100 mg Q4W and Q8W were well tolerated in PsA patients with no new safety concerns during his one-year phase III DISCOVER trial. The safety of guselkumab over 1 year in patients with PsA is consistent with that in patients with psoriasis treated with guselkumab.
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