Session Information
Date: Tuesday, October 23, 2018
Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: PsA is a chronic and complex inflammatory disease with both articular and extra-articular symptoms, including joint pain, enthesitis, dactylitis, fatigue, and skin and nail manifestations. Improvements in signs and symptoms of PsA have been demonstrated with ixekizumab treatment in patients experienced with biological DMARDs. Here we provide patient-reported outcomes through 2 years of ixekizumab treatment in patients with an inadequate response or intolerance to TNF inhibitors (TNFi).
Methods: In a Phase 3 study, patients who met CASPAR Classification Criteria for PsA and had an inadequate response or intolerance to 1 or 2 TNFi received subcutaneous ixekizumab 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W), after a 160 mg starting dose, or placebo (PBO) for up to 24 weeks. At Week 16, patients not meeting predefined criteria received rescue therapy. At Week 24, PBO patients were rerandomized to IXEQ2W or IXEQ4W. The ensuing ad hoc analyses are derived from patients in the intent-to-treat population initially randomized to ixekizumab. Patients self-rated multiple areas of health and quality of life on various scales, including the Fatigue Severity Numeric Rating Scale (Fatigue NRS [not yet validated]; 0 [none] to 10 [worst imaginable]), the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36; 0 [no improvement] to 100 [better function or health]), the European Quality of Life-5 Dimension visual analog scale (EQ-5D VAS; 0 [worst imaginable] to 100 [best imaginable]), and the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP). Missing values were imputed by a modified baseline observation carried forward approach.
Results: At 108 weeks of treatment, patients receiving either dose of ixekizumab showed sustained improvements in their level of fatigue, mental and physical component scores on the SF-36, quality of life on the EQ-5D, percentage of presenteeism, overall work impairment, and percentage of activities outside of work. Patients receiving IXEQ4W also showed sustained improvement in percentage of absenteeism, whereas those receiving IXEQ2W did not.
|
|
Baseline |
Change from Baseline at Week 108 |
||
|
|
IXEQ4W N=122 |
IXEQ2W N=123 |
IXEQ4W N=122 |
IXEQ2W N=123 |
|
Fatigue NRS |
n=120 5.9±2.5 |
n=119 6.0±2.5 |
n=109 -1.8±2.8 |
n=105 -2.3±2.9 |
|
SF-36, mental component score |
n=119 48.5±12.1 |
n=119 47.9±12.3 |
n=108 3.7±11.6 |
n=105 3.0±9.9 |
|
SF-36, physical component score |
n=119 32.7±9.2 |
n=119 32.2±9.5 |
n=108 6.8±10.2 |
n=105 6.9±10.5 |
|
EQ-5D VAS |
n=119 53.9±22.4 |
n=119 53.9±19.7 |
n=108 12.2±22.5 |
n=105 10.7±22.5 |
|
WPAI-SHP, percentage of absenteeism |
n=64 11.6±26.6 |
n=62 8.8±23.2 |
n=60 -0.13±19.8 |
n=56 4.2±31.1 |
|
WPAI-SHP, percentage of presenteeism |
n=60 45.0±25.7 |
n=59 37.0±25.0 |
n=56 -21.1±28.1 |
n=53 -20.0±26.8 |
|
WPAI-SHP, overall work impairment score |
n=60 46.9±26.7 |
n=59 38.8±26.6 |
n=56 -20.5±29.8 |
n=53 -18.5±28.6 |
|
WPAI-SHP, percentage of impaired activities outside of work |
n=118 53.9±24.9 |
n=119 49.3±26.5 |
n=107 -23.6±28.8 |
n=105 -19.6±28.6 |
Data are mean±standard deviation.
Modified baseline observation carried forward method was used to impute missing data.
EQ-5D VAS=European Quality of Life-5 Dimension visual analog scale; IXEQ2W=ixekizumab 80 mg every 2 weeks; IXEQ4W=ixekizumab 80 mg every 4 weeks; N=number of patients in the analysis population; n=number of patients with non-missing data; NRS=Numeric Rating Scale; SF-36=Medical Outcomes Study 36-Item Short Form Health Survey; WPAI-SHP=Work Productivity and Activity Impairment-Specific Health Problem.
Conclusion: In patients with PsA and inadequate response or intolerance to TNFi, improvements in patient-reported outcomes were sustained through 2 years of ixekizumab treatment.
To cite this abstract in AMA style:
Turkiewicz A, Gellett AM, Kerr L, Birt J, Gratacos J. Long-Term Effect of Ixekizumab on Patient-Reported Outcomes in Patients with Psa and Inadequate Response to TNF Inhibitors: 2-Year Follow-up from a Phase 3 Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/long-term-effect-of-ixekizumab-on-patient-reported-outcomes-in-patients-with-psa-and-inadequate-response-to-tnf-inhibitors-2-year-follow-up-from-a-phase-3-study/. Accessed .ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-effect-of-ixekizumab-on-patient-reported-outcomes-in-patients-with-psa-and-inadequate-response-to-tnf-inhibitors-2-year-follow-up-from-a-phase-3-study/