Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials

Mark G Lebwohl, Ahmed M Soliman, Hongbo Yang, Jessie Wang, Kaitlin Hagan, Byron Padilla, Andreas Pinter, Mark G Lebwohl, Ahmed M Soliman, Hongbo Yang, Jessie Wang, Kaitlin Hagan, Byron Padilla, Andreas Pinter

Abstract

Introduction: Novel therapies have allowed psoriasis patients to achieve high levels of skin clearance and meaningful improvements in health-related quality of life measures; however, duration of these outcomes has not been evaluated. This study aimed to estimate the duration of Psoriasis Area and Severity Index (PASI) 90 and Dermatology Life Quality Index (DLQI) 0/1 among patients with moderate-to-severe psoriasis receiving risankizumab and other treatments.

Methods: Pooled data from four phase 3 randomized clinical trials of risankizumab were used to estimate the number and proportion of days with PASI90 and DLQI0/1 during the 1-year post-baseline period with an area-under-the-curve approach. Patients were classified into five cohorts on the basis of their treatment experience during the follow-up period: risankizumab (RISA) only, RISA followed by re-randomization to RISA or placebo (RISA and RISA/PBO), adalimumab (ADA) followed by re-randomization to ADA or RISA (ADA and ADA/RISA), ustekinumab (UST) only, and placebo followed by risankizumab (PBO/RISA).

Results: A total of 2101 patients were included in this analysis. Mean age was 47.5 years, 70% were males, and mean duration since psoriasis diagnosis was 18.6 years. Patients treated with RISA only throughout the study period experienced the longest PASI90 [245.7 days (67% over 1 year)] and DLQI0/1 [213.7 (59%)] duration. Patients treated with PBO/RISA [156.8 (43%)] and UST only [154.2 (42%)] experienced the shortest PASI90 duration. Similarly, patients treated with PBO/RISA experienced the shortest DLQI0/1 duration during the 52-week study period [90.5 (25%)].

Conclusion: Patients with moderate-to-severe psoriasis treated with risankizumab exhibited longer durations of PASI90 and DLQI0/1 than patients treated with other therapies.

Trial registration: ClinicalTrials.gov identifiers: UltIMMa-1 (NCT02684370), NCT02684357 (UltIMMa-2), IMMvent (NCT02694523), IMMhance (NCT02672852).

Keywords: Dermatology Life Quality Index; Health-related quality of life; Psoriasis; Psoriasis Area and Severity Index; Psoriasis skin clearance; Risankizumab.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study cohort classification based on treatment and re-randomization experience during the phase 3 risankizumab trials. ADA adalimumab, PASI Psoriasis Area and Severity Index, PBO placebo, RISA risankizumab, sPGA static Physician Global Assessment, UST ustekinumab, w week
Fig. 2
Fig. 2
Primary AUC analysis of PASI90 across study cohorts using mNRI imputation. ADA adalimumab, PASI Psoriasis Area and Severity Index, PBO placebo, RISA risankizumab, UST ustekinumab
Fig. 3
Fig. 3
Primary AUC analysis of DLQI0/1 across study cohorts using mNRI imputation. ADA adalimumab, DLQI Dermatology Life Quality Index, PBO placebo, RISA risankizumab, UST ustekinumab. aPatients from IMMhance trial did not collect DLQI data after week 16 and thus were excluded from the analysis. This resulted in exclusion of cohort B: RISA and RISA/PBO and a smaller sample of cohort E

References

    1. Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512–516. doi: 10.1016/j.jaad.2013.11.013.
    1. de Korte J, Sprangers MA, Mombers FM, Bos JD. Quality of life in patients with psoriasis: a systematic literature review. J Investig Dermatol Symp Proc. 2004;9(2):140–147. doi: 10.1046/j.1087-0024.2003.09110.x.
    1. Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(Suppl 2):ii18–23.
    1. Esposito M, Saraceno R, Giunta A, Maccarone M, Chimenti S. An Italian study on psoriasis and depression. Dermatology. 2006;212(2):123–127. doi: 10.1159/000090652.
    1. Mrowietz U, Kragballe K, Reich K, Spuls P, Griffiths CE, Nast A, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011;303(1):1–10. doi: 10.1007/s00403-010-1080-1.
    1. Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med. 2017;376(16):1551–1560. doi: 10.1056/NEJMoa1607017.
    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. Katugampola RP, Lewis VJ, Finlay AY. The Dermatology Life Quality Index: assessing the efficacy of biological therapies for psoriasis. Br J Dermatol. 2007;156(5):945–950. doi: 10.1111/j.1365-2133.2007.07817.x.
    1. Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650–661. doi: 10.1016/S0140-6736(18)31713-6.
    1. Reich K, Gooderham M, Thaci D, Crowley JJ, Ryan C, Krueger JG, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576–586. doi: 10.1016/S0140-6736(19)30952-3.
    1. Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(6):649–658. doi: 10.1001/jamadermatol.2020.0723.
    1. Fredriksson T, Pettersson U. Severe psoriasis–oral therapy with a new retinoid. Dermatologica. 1978;157(4):238–244. doi: 10.1159/000250839.
    1. Mazzotti E, Barbaranelli C, Picardi A, Abeni D, Pasquini P. Psychometric properties of the Dermatology Life Quality Index (DLQI) in 900 Italian patients with psoriasis. Acta Derm Venereol. 2005;85(5):409–413. doi: 10.1080/00015550510032832.
    1. Shikiar R, Willian MK, Okun MM, Thompson CS, Revicki DA. The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006;4:71. doi: 10.1186/1477-7525-4-71.
    1. Tada Y, Watanabe R, Noma H, Kanai Y, Nomura T, Kaneko K. Short-term effectiveness of biologics in patients with moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis. J Dermatol Sci. 2020;99(1):53–61. doi: 10.1016/j.jdermsci.2020.06.003.
    1. Yasmeen N, Sawyer LM, Malottki K, Levin LA, Didriksen Apol E, Jemec GB. Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year. J Dermatolog Treat. 2020:1–15.
    1. Armstrong AW, Puig L, Joshi A, Skup M, Williams D, Li J, et al. Comparison of biologics and oral treatments for plaque psoriasis: a meta-analysis. JAMA Dermatol. 2020;156(3):258–269. doi: 10.1001/jamadermatol.2019.4029.
    1. Shi J, Xu J, Chen Y. A network meta-analysis for the comparison of efficacy and safety of interleukin (IL)-23 targeted drugs in the treatment of moderate to severe psoriasis. Dermatol Ther. 2020:e13802.
    1. Gkalpakiotis S, Cetkovska P, Arenberger P, Dolezal T, Arenbergerova M, Velackova B, et al. Risankizumab for the treatment of moderate-to-severe psoriasis: real-life multicenter experience from the Czech Republic. Dermatol Ther. 2021;11(4):1345–1355. doi: 10.1007/s13555-021-00556-2.
    1. Hansel K, Zangrilli A, Bianchi L, Peris K, Chiricozzi A, Offidani A, et al. A 52-week update of a multicentre real-life experience on effectiveness and safety of risankizumab in psoriasis. J Eur Acad Dermatol Venereol. 2021 doi: 10.1111/jdv.17656.

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