Guselkumab (Tremfya) was found to have a favorable adverse event (AE) profile following a sweeping analysis of 11 phase II and phase III studies of patients with psoriasis and psoriatic arthritis (PsA).
The analysis of 4,399 guselkumab-treated patients appeared recently in the journal .
Those analyzed in the study collectively encompassed 10,787 person years (PYs). AE rates were similar between guselkumab- and placebo-treated patients and were consistent throughout long-term guselkumab treatment and across broad patient subgroups.
The study was conducted by a multinational team of researchers from the U.S., Canada, the United Kingdom, and Germany. The following study excerpts were edited for length and clarity.
What prompted this study?
Guselkumab, an IL-23 inhibitor, is approved for the treatment of adults with moderate- to-severe plaque psoriasis and active PsA. In randomized controlled trials, guselkumab had favorable efficacy and safety profiles for up to 5 years in psoriasis and up to 2 years in PsA.
The objective of the current analysis was to evaluate the cumulative safety experience of guselkumab in patients with psoriatic disease using pooled data from seven phase II/III studies in patients with moderate-to-severe psoriasis and four phase II/III studies in patients with active PsA.
In summary, what was the key finding?
Rates of serious AEs and AEs of particular interest were low and similar to placebo during short-term treatment; these remained low over the longer term. The favorable safety profile of guselkumab was consistent across a broad population of patients, irrespective of sex, age, BMI, and prior biologic use.
What were the specific results regarding serious AEs and AEs of particular interest?
In the guselkumab and placebo groups, respectively, overall AE rates were 281/100 PYs versus 272/100 PYs. Infection rates were 76/100 PYs and 72.2/100 PYs, respectively. Among guselkumab-treated patients, rates for specific AEs were: 61.2/100 PYs for infections, 5.4/100 PYs for serious AEs, 1.8/100 PYs for AEs leading to discontinuation, 1.0/100 PYs for serious infections, 0.6/100 PYs for malignancies, and 0.3/100 PYs for major adverse cardiovascular events.
No incidents of Crohn's disease, ulcerative colitis, or active tuberculosis were reported among guselkumab-treated patients. In the psoriasis studies, no opportunistic infections were reported among guselkumab-treated patients.
What are the bottom-line takeaways for clinicians?
This analysis confirms the reassuring long-term safety profile of guselkumab across both psoriasis and PsA, and as such can inform shared decision-making conversations between patients and clinicians with the goal of maximizing treatment satisfaction, adherence, and clinical outcomes.
The analysis also supports the gastrointestinal safety of guselkumab in psoriatic disease, as no cases of Crohn's disease or ulcerative colitis were reported in guselkumab-treated patients through the end of the long-term reporting period.
Key points
- Guselkumab (Tremfya) was shown to be safe in a large recent analysis of psoriasis and PsA patients.
- Serious and gastrointestinal AEs comparable between guselkumab and placebo.
- Results could inform shared decision-making and ultimately improve patient satisfaction and outcomes.
The authors report relationships with numerous pharmaceutical companies, including Janssen, maker of guselkumab.
Primary Source
Drug Safety
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