Guselkumab sustains improvements in PsA with sacroiliitis through 1 year
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Guselkumab administered once every 4 or 8 weeks improved axial outcomes in patients with psoriatic arthritis who have sacroiliitis through week 52, according to data published in The Lancet Rheumatology.
“Since the axial component of psoriatic arthritis is an important clinical domain for the patients that experience it, it is important to know whether or not a medication such as guselkumab can effectively treat the symptoms of axial PsA, which was demonstrated in this study,” Philip J. Mease, MD, of Swedish Medical Center and the University of Washington, in Seattle, told Healio Rheumatology. “There is also an interesting immuno-biologic question. The previous experience in using the p19 interleukin-23 inhibitor, risankizumab, in ankylosing spondylitis did not show efficacy in that small study.
“We might have had questions about whether this mechanism, IL-23, could benefit the axial component of PsA,” he added. “As such, it was an important immuno-biologic question to address. The fact that it did appear to improve the axial component of PsA is important to know. It raises the question, ‘Is axial PsA different enough immuno-biologically from ankylosing spondylitis that this medication class may work effectively in axial PsA, even if not in ankylosing spondylitis?’ And it has stimulated the plan to study guselkumab in a study specifically designated for axial PsA, which will proceed in the near future.”
To analyze the efficacy of guselkumab (Tremfya, Janssen) in endpoints related to axial involvement, among patients with PsA and imaging-confirmed sacroiliitis, Mease and colleagues conducted a post hoc analysis of data from the DISCOVER-1 and DISCOVER-2 studies. In these two trials, a total of 1,120 participants with active PsA were randomly assigned to receive 100 mg guselkumab either every 4 weeks or every 8 weeks, or a placebo.
For their analysis, Mease and colleagues included patients they determined to have axial disease based on documented prior imaging or pelvic radiograph that demonstrated sacroiliitis. These determinations were later confirmed by the researchers. In all, this included 312 participants — 128 who received guselkumab every 4 weeks, 127 every 8 weeks and 126 in the placebo group. Among these participants, 30% were HLA-B*27 positive while 70% were HLA-B*27 negative.
Efficacy outcomes included BASDAI score, BASDAI50, modified BASDAI — excluding peripheral joint pain — spinal pain, ASDAS-CRP score and ASDAS responses of inactive disease, major improvement and clinically important improvement.
According to the researchers, at week 24, least squares mean reductions from baseline in BASDAI were 2.7 in both guselkumab groups, compared with 1.3 in those who received a placebo. The researchers reported similar results for the modified BASDAI and spinal pain outcomes. Meanwhile, least squares mean changes in ASDAS scores at week 24 were –1.4 in both guselkumab groups, compared with –0.7 among those who received a placebo.
In addition, 38% of patients treated with guselkumab every 4 weeks, and 40% of those treated every 8 weeks, achieved the BASDAI50 outcome, compared with 19% in the placebo group, at week 24. The researchers also reported that greater proportions of participants treated with guselkumab achieved ASDAS responses compared with those in the placebo group. The impact of treatment was independent of HLA-B*27 status.
All of these improvements were maintained through week 52 in the guselkumab groups, the researchers wrote.
“When we studied a portion of the DISCOVER-1 and -2 patient population that investigators deemed had axial PsA and objective confirmation of sacroiliac changes by X-ray or MRI scan, we saw symptomatic benefit in using the classic measures for the axial component of PsA,” Mease said. “This is important because in roughly 40% of our patient population, the spine may be involved with immunologic inflammation and pain, and this gives some reassurance that the symptoms can be treated.”
“It is valuable to have a medication treat each of the clinical domains of PsA effectively and safely,” he added. “To know, in addition to the peripheral manifestations of the disease, that the axial symptoms can be improved is important.”
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