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  • Title: The effect of ixekizumab on axial manifestations in patients with psoriatic arthritis from two phase III clinical trials: SPIRIT-P1 and SPIRIT-P2.
    Author: Deodhar A, Gladman D, Bolce R, Sandoval D, Park SY, Leage SL, Nash P, Poddubnyy D.
    Journal: Ther Adv Musculoskelet Dis; 2023; 15():1759720X231189005. PubMed ID: 37645684.
    Abstract:
    BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory condition predominantly affecting the peripheral joints. However, some patients with PsA can experience axial involvement which is manifested with back pain and associated with increased burden of illness. OBJECTIVES: The aim of this post hoc analysis was to determine the efficacy of ixekizumab (IXE) up to 52 weeks in reducing axial symptoms in PsA patients, presenting with axial manifestations. DESIGN: This was a post hoc analysis of two pooled phase III clinical trials. METHODS: Patients with axial manifestations, from two placebo-controlled, randomized, double-blind, phase III trials (SPIRIT-P1 and SPIRIT-P2), were defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Q2; back pain)] total score ⩾4 and average of BASDAI Q5 + Q6 (morning stiffness) ⩾4 at baseline. For this post hoc analysis, the efficacy of IXE was evaluated at weeks 16, 24, and 52 using separate BASDAI questions (including back pain and morning stiffness), total BASDAI and modified BASDAI (mBASDAI; without Q3), Ankylosing Spondylitis Disease Activity Score (ASDAS), and 50% improvement in BASDAI (BASDAI50) response. Treatment comparisons were performed using logistic regression and analysis of covariance model for categorical and continuous end points, respectively. RESULTS: In the post hoc analysis among PsA patients with axial manifestations at baseline (N = 313), improvements in back pain and morning stiffness at weeks 16 and 24 were significantly greater in patients receiving IXE versus placebo (both p < 0.001). Improvements in BASDAI individual scores and total scores, mBASDAI, and ASDAS were significantly greater in patients receiving IXE compared with placebo. Similarly, significantly more IXE-treated patients achieved BASDAI50 at weeks 16 and 24 versus placebo. The effect of IXE was sustained at week 52. Similar effects were observed in sensitivity analyses subgroups. CONCLUSION: IXE is effective in improving axial symptoms in patients with active PsA presenting with axial manifestations. Ixekizumab improves symptoms of back pain and morning stiffness in patients with psoriatic arthritis Background: Psoriatic arthritis is a chronic, immune-mediated condition with heterogeneous manifestations including peripheral arthritis, axial arthritis, enthesitis, dactylitis, and skin and nail psoriasis. Some patients with psoriatic arthritis also experience symptoms relating to the spine and sacroiliac joint. These symptoms are referred to as axial manifestations of the psoriatic arthritis. Ixekizumab is a monoclonal antibody that targets IL-17A with high affinity. IL-17A has been implicated in the pathogenesis of PsA. Aim: The aim is to investigate the effects of ixekizumab in controlling symptoms suggestive of axial involvement in patients with active psoriatic arthritis. Methods: This post hoc analysis included patients with psoriatic arthritis from two phase III clinical trials. Only patients with psoriatic arthritis who had back pain and morning stiffness at baseline were included. In the second analysis, we assessed the effect of ixekizumab in a subset of patients with psoriatic arthritis with back pain who were aged less than 45 years. A third analysis included a subset of patients with increased CRP. Results: Our results show that patients with psoriatic arthritis and back pain suggestive of axial involvement experience a greater disease burden than patients without back pain. This post hoc analysis showed that ixekizumab was significantly better compared with placebo in improving inflammatory back pain, morning stiffness, and disease activity at weeks 16 and 24. Disease activity was also significantly improved in ixekizumab-treated patients compared with placebo. Conclusion: Axial manifestations in patients with psoriatic arthritis were significantly improved following ixekizumab treatment. These improvements were noted regardless of whether the patients were less than 45 years and regardless of the level of inflammation.
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