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Clinical Trial
. 2021 Jan;35(1):135-142.
doi: 10.1111/jdv.16558. Epub 2020 Jun 8.

Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY)

J Bagel  1 , A Blauvelt  2 , J Nia  3 , P Hashim  3 , M Patekar  4 , A de Vera  4 , K Ahmad  5 , B Paguet  4 , S Xia  6 , E Muscianisi  7 , M Lebwohl  3
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Clinical Trial

Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY)

J Bagel et al. J Eur Acad Dermatol Venereol. 2021 Jan.

Abstract

Background: Secukinumab demonstrated superior efficacy over ustekinumab in the treatment of moderate to severe plaque psoriasis over 16 weeks in the CLARITY study and over 52 weeks in the CLEAR study.

Objective: To compare the efficacy and safety of secukinumab vs. ustekinumab over 52 weeks in CLARITY.

Methods: Analysis of 52-week data from CLARITY (NCT02826603), a phase 3b study in which patients were randomized to receive secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label.

Results: At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (73.2% vs. 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < 0.0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs. 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < 0.0001) and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs. 61.2%; P = 0.0028). Proportions of patients with any adverse events were comparable between treatment arms.

Conclusions: This second head-to-head study confirmed the superior efficacy of secukinumab over ustekinumab in skin clearance and quality of life through 52 weeks, with safety comparable to that reported in previous trials. Clinicaltrials.gov identifier: NCT02826603.

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Figures

Figure 1
Figure 1
Design of the CLARITY study. BL, baseline; EOT, end of treatment phase; F4, follow‐up visit approximately 4 weeks after the EOT visit; F8, follow‐up visit approximately 8 weeks after the EOT visit. *The screening phase duration was at least 2 weeks and up to 4 weeks. †For patients with premature treatment discontinuation only. ‡Ustekinumab dose was based on bodyweight at baseline; 45 mg for patients ≤100 kg; 90 mg for patients >100 kg. ↓Active dose administration; patients received placebo at several time points to maintain blinding (not shown).
Figure 2
Figure 2
Improvement in skin symptoms as measured by (a) PASI 75, (b) PASI 90 and (c) PASI 100 responses through week 52 (multiple imputation). OR, odds ratio; PASI, Psoriasis Area and Severity Index. *P < 0.0001 vs. ustekinumab 45/90 mg. **P < 0.01 vs. ustekinumab 45/90 mg.
Figure 3
Figure 3
Improvement in skin symptoms as measured by (a) IGA mod 2011 0/1 and (b) IGA mod 2011 0 responses through week 52 (multiple imputation). IGA mod 2011, Investigator’s Global Assessment modified 2011; OR, odds ratio. *P < 0.0001 vs. ustekinumab 45/90 mg. **P < 0.01 vs. ustekinumab 45/90 mg.
Figure 4
Figure 4
DLQI 0/1 response assessed by Fisher exact test through week 52 (last observation carried forward). DLQI, Dermatology Life Quality Index. *P < 0.0001 vs. ustekinumab 45/90 mg. **P < 0.01 vs. ustekinumab 45/90 mg.
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References

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