Artikel
Sustained improvement in skin symptoms, physical functioning, and qualitiy of life with secukinumab versus ustekinumab in patients with moderate-to-severe psoriasis and concomitant psoriatic arthritis: 52 week results from the CLEAR study
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Autoren
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Diamant Thaci
- Exzellenzzentrum Entzündungsmedizin der Universität zu Lübeck, Dermatologie, Lübeck
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Alice B. Gottlieb
- Tufts Medical Center, Boston, MA, USA
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Andrew Blauvelt
- Oregon Medical Research Center, Portland, Oregon, USA
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Vaishali Bhosekar
- Novartis Healthcare Pvt Ltd, Hyderabad, Indien
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Marina Milutinovic
- Novartis Pharma AG, Basel, Switzerland
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Chetan Karyekar
- Novartis Pharmaceuticals Corporation, East Hanover, USA
| Veröffentlicht: | 29. August 2016 |
|---|
Gliederung
Text
Background: In the randomised, double-blind CLEAR study secukinumab (IL-17A-inhibitor) demonstrated superior efficacy (PASI90) over ustekinumab IL-12/23inhibitor) in patients with moderate-to-severe plaque psoriasis [1]. Secukinumab improved skin symptoms and physical functioning at 16 wks in the subgroup with concomitant PsA [2].
Objectives: To report 52 wk results in the subgroup with concomitant PsA.
Methods: Patients were randomised 1:1 to receive secukinumab 300 mg sc or ustekinumab (patients≤100 kg, 45 mg sc; >100 kg, 90 mg sc). Secukinumab administered at BL, Wks 1, 2, and 3, and every 4 wks from Wk 4 and ustekinumab at BL, Wk 4, and every 12 wks from Wk 16. The primary endpoint was the proportion of patientsachieving ≥90% reduction in PASI score at Wk 16. PASI 75, PASI 90, PASI 100, and IGA mod 2011 responses over time, and changes in the HAQ-DI, WPAI, and DLQI were analysed in the subgroup with concomitant PsA.Analyses used non-responder imputation for efficacy assessments and observed data for PROs.
Results: Of the 676 patients randomised, 610 (93.7%) completed 52 wks of study (secukinumab , 312 [94.8%]; ustekinumab , 298 [92.5%]). PASI 90 response was achieved by 79.0% vs. 57.6% (P <0.0001) and 74.9% vs. 60.6% (P </i≥ 0.0001) patients receiving secukinumab vs. ustekinumab at Wk 16 and Wk 52, respectively. Concomitant PsA was reported in 69/337 (Secukinumab, 20.5%) and 54/339 (ustekinumab, 15.9%) patients. In the subgroup with concomitant PsA, a higher proportion of patients in the secukinumab group achieved a PASI 90 response at Wk 52; 77.6% vs. 63.5% (P <0.05). The mean change (baseline to Wk 52) in HAQ-DI was –0.30 (secukinumab) vs. –0.13 (ustekinumab). A higher proportion of patients receiving secukinumab achieved HAQ-DI response vs. ustekinumab at Wk 52 (39.4% vs. 23.5%). Greater improvements were observed in other parameters with secukinumab vs. ustekinumab in the PsA subgroup.
Table 1 [Tab. 1]
Conclusion: The significant efficacy of secukinumab vs. ustekinumab in clearing psoriasis was sustained through 52 wks in patients with moderate-to-severe plaque psoriasis. In the subgroup with concomitant PsA, secukinumab was associated with greater improvements in skin symptoms, physical functioning, quality of life, and work productivity.
References
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