Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J)

Masaru Honma, Zhihong Cai, Russel Burge, Baojin Zhu, Sohiya Yotsukura, Hitoe Torisu-Itakura, Masaru Honma, Zhihong Cai, Russel Burge, Baojin Zhu, Sohiya Yotsukura, Hitoe Torisu-Itakura

Abstract

Introduction: Ixekizumab has demonstrated rapid onset of action, high levels of skin clearance, and improvements in quality of life in patients with moderate-to-severe psoriasis, including plaque, erythrodermic, or generalized pustular psoriasis.

Methods: This was a post hoc analysis of UNCOVER-J, a phase 3, multicenter, single-arm, open-label study of ixekizumab for treatment of Japanese patients with psoriasis. The objective was to assess the proportion of patients who achieved Dermatology Life Quality Index (DLQI) (0,1) and Itch Numeric Rating Scale (NRS) (0) at weeks 4 and 12 according to Psoriasis Area and Severity Index (PASI) percentage improvement levels. All intent-to-treat patients with plaque, erythrodermic, or generalized pustular psoriasis were analyzed.

Results: A total of 91 patients were treated with ixekizumab and included in the analysis. Rapid improvements in PASI at weeks 4 and 12 were associated with improvements in DLQI (0,1) response at week 4 and at week 12. Complete skin clearance (PASI 100) achieved either at week 4 or week 12 was associated with a higher Itch NRS (0) response at week 12.

Conclusions: Patients with rapid improvement in clinical symptoms of psoriasis had better patient outcomes than those with slower responses. These findings highlight the clinical importance of achieving a fast response in patients with psoriasis, which may lead to better treatment outcomes.

Trial registration: ClinicalTrials.gov identifier, NCT01624233.

Keywords: Health-related quality of life; Ixekizumab; Japan; Psoriasis.

Figures

Fig. 1
Fig. 1
Association between Psoriasis Area and Severity Index (PASI) improvement and Dermatology Life Quality Index (DLQI) (0,1) response rates in patients treated with ixekizumab for 4 and 12 weeks. DLQI (0,1) represents an outcome of no effect of skin condition on patient’s quality of life; PASI 75/90/100 = 75%/90%/100% reduction in PASI. aAt week 12, the groups for PASI < 75 and 75 ≤ PASI < 90 were combined because most patients achieved PASI ≥ 75 at week 12. p, chi-square test
Fig. 2
Fig. 2
Association between Psoriasis Area and Severity Index (PASI) improvement and Itch Numeric Rating Scale (NRS) (0) response rates in patients treated with ixekizumab for 4 and 12 weeks. Itch NRS (0) represents complete resolution of itch; PASI 75/90/100 = 75%/90%/100% reduction in PASI. aAt week 12, the groups for PASI < 75 and 75 ≤ PASI < 90 were combined because most patients achieved PASI ≥ 75 at week 12. p, chi-square test
Fig. 3
Fig. 3
Receiver operating characteristic curves for the week 4 Psoriasis Area and Severity Index (PASI) percentage improvement for predicting Dermatology Life Quality Index (DLQI) (0,1) and Itch Numeric Rating Scale (NRS) (0) response rates in patients treated with ixekizumab for 12 weeks. DLQI (0,1) represents an outcome of no effect of skin condition on patient’s quality of life and Itch NRS (0) represents complete resolution of itch. AUC area under the curve

References

    1. Edson-Heredia E, Zhu B, Guo J, Maeda-Chubachi T, Lebwohl M. Disease burden and quality of life in psoriasis patients with and without comorbid psoriatic arthritis: results from National Psoriasis Foundation panel surveys. Cutis. 2015;95(3):173–178.
    1. Takahashi H, Satoh K, Takagi A, Iizuka H. Cost-efficacy and pharmacoeconomics of psoriatic patients in Japan: analysis from a single outpatient clinic. J Dermatol. 2019;46(6):478–481. doi: 10.1111/1346-8138.14876.
    1. Mabuchi T, Yamaoka H, Kojima T, Ikoma N, Akasaka E, Ozawa A. Psoriasis affects patient’s quality of life more seriously in female than in male in Japan. Tokai J Exp Clin Med. 2012;37(3):84–88.
    1. Blome C, Gosau R, Radtke MA, et al. Patient-relevant treatment goals in psoriasis. Arch Dermatol Res. 2016;308(2):69–78. doi: 10.1007/s00403-015-1613-8.
    1. Liu L, Lu J, Allan BW, et al. Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. J Inflamm Res. 2016;9:39–50. doi: 10.2147/JIR.S100940.
    1. Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541–551. doi: 10.1016/S0140-6736(15)60125-8.
    1. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345–356. doi: 10.1056/NEJMoa1512711.
    1. Yosipovitch G, Dong Y, Burge R, Zhu B, Shrom D, Kimball AB. Assessing the impact of improvements in PASI and itch scores on patients’ quality of life in the treatment of psoriasis. Acta Derm Venereol. 2019;99(11):1031–1032. doi: 10.2340/00015555-3254.
    1. Zhu B, Edson-Heredia E, Guo J, Maeda-Chubachi T, Shen W, Kimball AB. Itching is a significant problem and a mediator between disease severity and quality of life for patients with psoriasis: results from a randomized controlled trial. Br J Dermatol. 2014;171(5):1215–1219. doi: 10.1111/bjd.13065.
    1. Saeki H, Nakagawa H, Ishii T, et al. Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. J Eur Acad Dermatol Venereol. 2015;29(6):1148–1155. doi: 10.1111/jdv.12773.
    1. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210–216. doi: 10.1111/j.1365-2230.1994.tb01167.x.
    1. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502–507. doi: 10.2340/00015555-1246.
    1. Garduno J, Bhosle MJ, Balkrishnan R, Feldman SR. Measures used in specifying psoriasis lesion(s), global disease and quality of life: a systematic review. J Dermatol Treat. 2007;18(4):223–242. doi: 10.1080/09546630701271807.

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