IL-17 inhibitor effective in axial manifestations of psoriatic arthritis

The IL-17 inhibitor secukinumab is the first biologic that demonstrated distinct activity in axial manifestations of psoriatic arthritis. This was the result of the phase 3b MAXIMISE study.

Psoriatic arthritis (PsA) affects approximately 20–30% of patients with psoriasis and 25–70% may have axial disease [1–3]. Despite the frequency of this phenomenon, validated criteria to classify this subtype of PsA are still lacking. In addition, not much data is available on whether biologics used to treat psoriasis are effective in axial manifestations. In the case of the IL-17 inhibitor secukinumab, this question has now been answered positively in the MAXIMISE phase 3b study (NCT02721966) [2].

MAXIMISE included 498 patients with PsA according to the CASPAR criteria and axial manifestations (with a spinal pain visual analogue score ≥40/100 and Bath Ankylosing Spondylitis Activity [BASDAI] score ≥4). All patients had severe axial pain despite therapy with ≥2 non-steroidal anti-inflammatory drugs. Included patients were treated with either 150 or 300 mg secukinumab or placebo for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab (300 or 150 mg) and treated until week 52. Modified nail psoriasis severity index (mNAPSI) score was an exploratory endpoint at weeks 12 and 52 measured by the least squares mean.

After a treatment period of 12 weeks, significantly more PsA patients achieved a 20% and 40% improvement, respectively, in axial manifestations, determined as Assessment of SpondyloArthritis International Society (ASAS) 20 and 40 response, a well-established tool in rheumatology for assessing axial skeletal manifestations. The primary and key secondary endpoints were met: ASAS 20 responder rates at week 12 were 62.9% (secukinumab 300 mg; P<0.0001) and 66.3% (secukinumab 150 mg; P<0.0001) versus 31.2% (placebo). At week 12, the mNAPSI score improved with secukinumab: it was reduced by -4.8 in the group receiving 300 mg secukinumab and by -3.5 in the group receiving 150 mg secukinumab versus -1.4 in the placebo group. The responder rates further improved in treatment period 2 (12–52 weeks): at week 52, ASAS 20 responder rates for secukinumab 300 mg were 81.3% and 80.1% for the lower secukinumab dose group. In addition, the mNAPSI improvement observed at week 12 increased through week 52: at this time 84% and 81% of patients achieved clearance of nail psoriasis with 300 and 150 mg secukinumab, respectively. The clinical improvement was accompanied by a significant improvement in inflammatory lesions on MRI over the 52 weeks. This included lesions in both the spine and sacroiliac joints.

1. Baraliakos X, et al. Efficacy of secukinumab in managing axial manifestations and nail psoriasis in patients with psoriatic arthritis: results from the MAXIMISE trial. Poster 25851, AAD VMX 2021, 23-25 April.
2. Reich K, et al. Br J Dermatol 2009; 160 (5):1040-7.
3. Mease PJ, et al. J Am Acad Dermatol 2013; 69 (5):729-35.

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Posted on 7 June 202123 April 2024