Session Type: ACR Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: Patients (pts) with axial spondyloarthritis (axSpA) often experience delayed diagnosis, which can lead to treatment delay. However, there are indications that earlier treatment with anti-TNFs can lead to a greater clinical response. Certolizumab pegol (CZP) has been shown to improve the signs and symptoms of non-radiographic (nr)-axSpA.1 However, it is not known if earlier CZP treatment has a greater impact on efficacy in nr-axSpA. Here we report clinical and pt-reported outcomes in pts with active nr‑axSpA treated with CZP or placebo (PBO) over 52 weeks (wks) stratified by their symptom duration.
Methods: C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicenter study including a 52‑wk double-blind, PBO-controlled period (completed).1 Pts had previous inadequate response to ≥ 2 NSAIDs and were randomized 1:1 to PBO or CZP (400 mg at Wks 0/2/4, then 200 mg every 2 wks). This post-hoc analysis reports outcomes at Wk 12 and Wk 52 in pts stratified by their baseline symptom duration (< 5 and ≥ 5 years; key clinical outcomes also reported for < 3 and ≥ 3 years). Outcomes included: Ankylosing Spondylitis Disease Activity Score – Major Improvement (ASDAS-MI), Assessment in SpondyloArthritis international Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), nocturnal spinal pain, fatigue (BASDAI Q1), morning stiffness (average of BASDAI Q5 and Q6), and the 36-Item Short Form Survey (SF-36) physical and mental component summary (PCS/MCS). Subjects with missing values or values observed after discontinuing double-blind study treatment were considered as non-responders for binary measures or, for quantitative measures, had the last observation from double‑blind treatment carried forward
Results: Of 317 recruited pts, 159 were randomized to CZP, and 158 to PBO. The median (range) baseline (BL) symptom duration was 4.9 (1.0–41.9) years for CZP-treated pts and 5.2 (1.1–38.2) years for PBO pts. 50.3% (80/159) CZP pts and 48.7% (77/158) PBO pts had a symptom duration < 5 years. At Wks 12 and 52, ASDAS-MI and ASAS40 responder rates, and improvements in BASDAI, nocturnal spinal pain, fatigue, morning stiffness and SF-36 PCS were substantially better among CZP-treated pts with shorter symptom duration (< 5 years at BL) vs longer symptom duration (Table). Amongst PBO pts, responses were low and there was no consistent trend in outcomes by symptom duration (Table). Similarly, using a cut-off of 3 years, responder rates for ASDAS-MI and ASAS40 were greater in CZP-treated pts with shorter symptom duration: at Wk 52, 56.4% (31/55) and 42.3% (44/104) of pts with < 3 and ≥ 3 years symptom duration achieved ASDAS-MI, respectively, while 65.5% (36/55) and 51.9% (54/104) achieved ASAS40.
Conclusion: In this post-hoc analysis, CZP-treated nr-axSpA pts with shorter symptom duration (< 5 vs ≥ 5 years) showed greater improvements across signs and symptoms of disease and in quality of life. To our knowledge, this is the first report indicating that early CZP treatment for nr-axSpA may be beneficial to pts.
1. Deodhar A. Arthritis Rheumatol 2019; doi: 10.1002/art.40866.
To cite this abstract in AMA style:Kay J, Gensler L, Deodhar A, Maksymowych W, Haroon N, Auteri S, de Peyrecave N, Kumke T, Hoepken B, Bauer L, Rudwaleit M. Earlier Treatment of Non-Radiographic Axial Spondyloarthritis with Certolizumab Pegol Results in Improved Clinical and Patient-Reported Outcomes [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/earlier-treatment-of-non-radiographic-axial-spondyloarthritis-with-certolizumab-pegol-results-in-improved-clinical-and-patient-reported-outcomes/. Accessed April 13, 2021.
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