Positive secukinumab results for axial manifestations in PsA
medwireNews: Secukinumab improves axial manifestations in patients with psoriatic arthritis (PsA) and an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs), primary analysis of the phase III MAXIMISE trial shows.
“We present here the first randomized controlled trial evaluating the efficacy of a biologic DMARD in the management of PsA patients who suffer from axial manifestations,” commented Xenofon Baraliakos (Ruhr University Bochum, Germany) at the EULAR 2019 congress in Madrid, Spain.
He reported that patients treated with the interleukin-17a inhibitor at a weekly subcutaneous dose of 300 mg were 3.8 times more likely to achieve an ASAS20 response after 12 weeks than patients treated with placebo, and 4.3 times more likely when given the drug at a weekly dose of 150 mg.
At baseline, despite having tried treatment with at least two NSAIDs, the study participants had a spinal pain score of around 73 points on a 0 to 100 mm visual analog scale, active spinal disease with an average BASDAI score of about 7 points, and a 7–8-year duration of axial symptoms.
They were randomly assigned to weekly subcutaneous secukinumab 300 mg (n=167) or 150 mg (n=165) or placebo (n=166) for 4 weeks, and every 4 weeks thereafter for up to 12 weeks, at which point patients in the placebo group were re-randomized to secukinumab for a further 36 weeks.
Baraliakos reported that at the 12-week mark, the rate of ASAS20 response after multiple imputation for missing values was 63.1% and 66.3% for patients receiving secukinumab 300 mg and 150 mg, respectively, versus 31.3% for patients in the placebo group – a difference that Baraliakos said was “clearly significantly different.” The observed rates for the whole group and after non-responder imputation were also similar.
Baraliakos added that there was “a fast response” to secukinumab, “which increased slightly over time,” and “there was no difference between the doses.”
He also noted that the benefit with secukinumab was evident regardless of whether or not patients were taking concomitant methotrexate.
Among 296 patients also taking methotrexate, 65.1% of those taking the maximum secukinumab dose were ASAS20 responders at 12 weeks, as were 67.3% of those taking the lower dose, compared with 33.9% of those taking placebo. For the 189 patients not taking methotrexate, the corresponding values were 60.5% and 64.4% versus 27.1%.
The 1-year results, which will include all imaging data, are expected to be available by the end of 2019, Baraliakos concluded.
By Lucy Piper
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
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