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Guselkumab
SC injection now approved for treatment in patients with active psoriatic arthritis.
The guselkumab injectable formulation by a renowned pharmaceutical company was approved by FDA for plague psoriasis on 13 July, 2017. Now, it was recently approved for active psoriatic arthritis (PsA) treatment on 14 July, 2020, the company stated.
The guselkumab, an interleukin-23 (IL-23) antagonist, when used subcutaneously (SC) provided significant improvement in symptoms of active PsA patients, as revealed from 2, phase 3 trials; DISCOVER-1 and DISCOVER-2 intended to find its safety and efficacy in PsA. All in all, 381 active PsA patients with inadequate response to standard therapies, including anti-TNF alpha biologics were included in DISCOVER-1 study. About 739 biologic-naïve patients with inadequate response to standard therapies were considered for DISCOVER-2 study. These patients were given either guselkumab 100mg SC every 4 weeks, or guselkumab 100mg at week 0, 4, and afterwards every 2 months, or placebo. Outcomes from both studies met primary end point with 52% and 64% of patients on guselkumab therapy every 2 months accomplishing an American College of Rheumatology 20 response at week 24 than with 22% and 33% in placebo patients.
Some notable secondary end points at week 24 versus placebo with guselkumab used every 8 weeks in DISCOVER-1 and DISCOVER-2 were:
Considering safety, guselkumab was found
to be consistent with that observed in earlier trials with similar serious adverse
events like those with placebo.
Janssen
https://www.empr.com/home/news/tremfya-approved-for-active-psoriatic-arthritis-guselkumab-janssen/
Tremfya Approved for Active Psoriatic Arthritis
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