Background/Purpose: Ixekizumab (IXE) is a selective interleukin-17A antagonist that has proven effective in Phase 3 and 4 clinical trials for patients with psoriatic arthritis (PsA).

Methods: Psoriatic Arthritis Real-World Study in the US (PARTUS) was a prospective, multicenter, non-interventional study conducted in patients with PsA who were starting treatment with IXE or an interleukin-23p19 inhibitor (IL-23i). We present improvements in patient-reported outcomes (PROs) from the study.The following outcomes were assessed at Week (W) 4 and W12: proportion of patients achieving Psoriatic Arthritis Impact of Disease (PsAID)-12 remission, change from baseline (CFB) in the patient spinal pain score measured by question 2 (Q2) (spinal pain item) of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (in patients with axial involvement), and CFB in Patient Global Assessment of Disease Activity (PtGA) Visual Analog Scale (VAS) score. Minimal Clinically Important Differences were evaluated: proportion of patients achieving a ≥ 10 score decrease in patient pain VAS score, a ≥ 10 score decrease in PtGA VAS score, and a ≥4 score increase in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue score. Abbreviated Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) scores were also assessed.Descriptive statistics for IXE and IL-23i groups are presented.

Results: BL characteristics of 121 patients from the IXE cohort and 116 patients from the IL-23i cohort (risankizumab (n=67) and guselkumab (n=49)) are in Table 1.At W4, 57.4% in the IXE cohort and 47.3% in the IL-23i cohort reported a ≥ 10 point decrease in patient pain VAS score. Both cohorts had additional progress by W12 (Figure (Fig.) 1B). The mean (SD) CFB in PtGA VAS score at W4 was -20.2 (24.5) and -8.6 (27.2), and at W12 was -22.9 (27.4) and -14.9 (27.6) in the IXE and IL-23i cohorts respectively (Fig. 1C). At W4, 73.8% and 53.1%, and at W12, 73.7% and 60.4% reported a ≥ 10 point decrease in PtGA VAS score in the IXE and IL-23i cohorts, respectively (Fig. 1D). At W4, 61.8% in the IXE cohort and 46.0% in the IL-23i cohort, and at W12, 69.9% in the IXE cohort and 60.2% in the IL-23i cohort reported ≥ 4point improvements in fatigue (Fig. 1E). The mean (SD) CFB in spinal pain score by Q2 of BASDAI was -1.4 (1.9) and -0.3 (2.9) at W4 and -1.6 (1.7) and -0.8 (2.5) at W12 for IXE and IL-23i cohorts (Fig. 1F). The proportions of patients achieving PsAID-12 remission at W4 were 13.0% and 3.1% in the IXE and IL-23i cohorts, respectively, with further improvements reported by W12 in both cohorts of patients (Fig. 1A).The TSQM-9 convenience domain scores were higher than the other domains of effectiveness and global satisfaction (Table 2).

Conclusion: The findings from the PARTUS study demonstrate that IXE rapidly improves quality of life and disease severity as early as week 4 in real-world settings for patients with PsA, with further improvements through week 12. Meaningful improvements were observed in PsAID-12, BASDAI, patient pain VAS, PtGA VAS score, as well as in FACIT-Fatigue scores. Convenience was the highest scoring treatment satisfaction domain. The rapid week 4 improvements in IXE treated patients were also observed in IL-23i treated patients, although to a less numerical extent.

Table 1. Demographic and Clinical Characteristics at Baseline in patients with active PsA treated with IXE or IL-23i (GUS and RZB)

Notes: Data are mean (SD) unless otherwise stated.

Abbreviations: BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BMI=body mass index; FACIT = Functional Assessment of Chronic Illness Therapy; GUS= guselkumab; IL-23i=interleukin-23p19 inhibitor; IXE=ixekizumab; N&#3fnumber of patients in each cohort; n=number of patients in the specified category; PsA=psoriatic arthritis; PsAID-12=Psoriatic Arthritis Impact of Disease; RZB=risankizumab; SD=standard deviation; TSQM-9, abbreviated Treatment Satisfaction Questionnaire for Medication-9.

Figure 1. Patient-reported outcomes at W4 and W12 in patients with PsA treated with IXE or IL-23i (GUS and RZB): A. Proportion of patients achieving PsAID-12 Remission; B. Proportion of patients achieving a ≥ 10 score decrease in patient pain VAS score; C. Change from baseline in PtGA VAS score; D. Proportion of Patients achieving a ≥ 10 score decrease in PtGA VAS score; E. Proportion of patients achieving ≥ 4 score increase from baseline in the FACIT-Fatigue score; F. Change from baseline in patient spinal pain score as measured by question 2 of the BASDAI.

Note: The study was not designed for comparative analysis, so only descriptive results are provided.

a In patients with PSAID-12 score > 1.4 at Baseline.

b In patients with patient pain VAS score ≥ 10 at baseline

c In patients with baseline score >0

d In patients with PtGA VAS Score ≥ 10 at baseline

e In patients with FACIT-Fatigue score ≤ 48 at baseline

f In patients with axial involvement at baseline

Abbreviations: BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BL=Baseline; CFB=Change from baseline; GUS=guselkumab; IL-23i=interleukin-23p19 inhibitor; IXE=ixekizumab; n=number of patients in the specified category; PsAID-12=Psoriatic Arthritis Impact of Disease; PtGA=Patient Global Assessment of Disease Activity; RZB=risankizumab; VAS = Visual Analog Scale.

Table 2. TSQM-9 scores from patients with active PsA treated with IXE or IL-23i (GUS and RZB)

Note: Data are mean (SD) unless otherwise stated.

Abbreviations: GUS=guselkumab; IL-23i=interleukin-23p19 inhibitor; IXE=ixekizumab; N&#3fnumber of patients in each cohort; PsA=psoriatic arthritis; RZB=risankizumab; SD=standard deviation; TSQM-9, abbreviated Treatment Satisfaction Questionnaire for Medication-9.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/ixekizumab-provided-rapid-improvements-in-quality-of-life-and-disease-activity-in-patients-with-psoriatic-arthritis-findings-from-a-real-world-study-in-the-united-states-of-patients-initiating-ixekiz/