medwireNews: People initiating the interleukin (IL)-12/23 inhibitor ustekinumab for active psoriatic arthritis (PsA) achieve similar outcomes irrespective of whether the drug is given with or without methotrexate, show data presented at the ACR Convergence 2021 virtual meeting.
Michaela Köhm, from Goethe University Frankfurt in Germany, reported that DAS28-ESR fell from a mean 4.8 points at baseline to 3.1 points at week 24 in the 87 participants randomly assigned to receive ustekinumab plus new or ongoing methotrexate, giving a mean reduction of 1.7 points.
This was not significantly different from the mean reduction of 1.7 points observed among the 79 participants randomly assigned to receive ustekinumab plus placebo, for whom average DAS28-ESR fell from 4.6 points at baseline to 2.9 points at week 24.
Furthermore, the lack of difference between the two groups met noninferiority criteria for ustekinumab monotherapy versus combination therapy, with the lower stratified Mann-Whitney estimator confidence interval of 0.4545 falling above the cutoff of 0.375 and its equivalent noninferiority margin of 12.5%.
The poster by Köhm and co-authors also demonstrated that changes in other outcomes such as joint counts, DAPSA, PASI, enthesitis, dactylitis, and quality of life were similar between the two groups at week 24.
In addition, a subgroup analysis by baseline treatment status showed significantly greater improvements in DAS28-ESR among methotrexate-naïve participants in each treatment group relative to their methotrexate pretreated counterparts.
The differences between the two treatments, however, remained similar within each baseline subgroup. Specifically, DAS28-ESR fell by 1.9 and 2.1 points in the methotrexate-naïve participants who received ustekinumab with and without methotrexate, respectively.
For the individuals who had previously received methotrexate at baseline, the corresponding reductions in DAS28-ERS were 1.5 and 1.3 points at week 24.
Finally, Köhm noted that serious adverse event rates were similar between the two treatment arms, at 9.2% in the ustekinumab plus methotrexate group and 8.9% in the ustekinumab plus placebo group.
“IL-12/23 inhibition with ustekinumab is an effective treatment for active PsA independent of methotrexate use,” Köhm concluded.
She added: “Based on these data, there is no evidence to either add methotrexate or maintain ongoing methotrexate when starting ustekinumab.”
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ACR Convergence 2021; 3–9 November