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:

• ACR50 response of 30% and 31% versus 9% and 14% (both P <.0001);
• Investigator’s Global Assessment (IGA) psoriasis response of clear (0) or almost clear (1): 57% and 70% versus 15% and 19%;
• Superior response rates for ACR70, Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100; 
• Statistically noteworthy and clinically meaningful improvements in Health Assessment Questionnaire Disability Index and the 36-Item Short-Form Health Survey Physical Component Summary score (PCS)

Considering safety, guselkumab was found to be consistent with that observed in earlier trials with similar serious adverse events like those with placebo.