medwireNews: Neihulizumab, a novel monoclonal antibody that binds to the cell-surface protein CD162, may reduce disease activity in patients with psoriatic arthritis (PsA), show phase 2a study data presented at the ACR Convergence 2020 virtual meeting.
In their poster, Stanley Cohen (University of Texas Southwestern Medical School at Dallas, USA) and co-authors explained that when neihulizumab binds to human CD162 (PSGL-1) it preferentially induces apoptosis in late-stage activated T cells.
They said that the drug is being tested in a number of putative T-cell mediated inflammatory diseases including ulcerative colitis and graft-versus-host disease, as well as in their study consisting of 20 patients (60% women, median age 55.5 years) with moderately to severely active PsA.
The study participants, who had a median PsA duration of 4.5 years and a median psoriasis duration of 25.0 years, each received intravenous neihulizumab 9 mg/kg on day 1 of weeks 0, 1, 2, 4, 6, 8, and 10.
Cohen and team reported that 40% of patients achieved the primary endpoint of an ACR20 response at week 12. Of these, four had previously been exposed to biologics for PsA.
In addition, 30% of participants had an ACR50 response at week 12 and 10% had an ACR70 response, with peak responses for all three outcomes observed at weeks 8 and 12. After this point the response rates fell, but at least half of the responders in each ACR category continued to have the same levels of response at week 24.
Analysis of a number of secondary endpoints showed a similar response. For example, DAS28 was a mean 1.0 point lower at week 12 and 0.7 points lower at week 24 than it was at baseline, and seven of the eight participants with an ACR20 response had a DAS28 reduction of more than 1.2 points.
Furthermore, pain VAS was a mean 8.0 points lower at week 12 versus baseline, and a mean 4.0 points lower at week 24, while Target Lesion Psoriasis Severity Scores were 2.4 and 2.5 points lower, respectively.
The investigators note that neihulizumab treatment was well tolerated by the patients, with no serious adverse events (AEs), AEs of grade 3 or higher, or treatment-related deaths reported.
Treatment-emergent AEs occurred in 65% of participants, with urinary tract infection (15%), psoriatic arthropathy (15%), headache (10%), sinus congestion (10%), and hematoma (10%) the most common.
Cohen et al concluded that the data suggest “there may be clinical utility with this novel agent for the treatment of psoriatic arthritis.”
They added that controlled trials are now indicated.
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ACR Convergence virtual meeting; 5–9 November 2020