Time to Loss of Response following Withdrawal of Ixekizumab in Patients with Moderate-to-Severe Psoriasis
DOI:
https://doi.org/10.2340/actadv.v102.1984Keywords:
ixekizumab, plaque psoriasis, withdrawal, disease modification, remission, sustained off-treatment responsesAbstract
In clinical practice, interruption of treatment may not result in immediate cessation of disease control, and some patients even experience sustained treatment response following treatment interruption. This post hoc analysis of UNCOVER-1 and -2 Phase 3 clinical trials characterized the time to loss of treatment response in patients with psoriasis who responded to ixekizumab through a 12-week treatment period, and who were then re-randomized to placebo for the following 48 weeks. For those with static Physician Global Assessment [sPGA]0/1 and Psoriasis Area and Severity Index [PASI]90 at Week 12, the median time to loss of PASI90 was 16.1 weeks (95% confidence interval 12.7–16.4). For those with PASI100 at Week 12, the median time to loss of PASI100 was 12.1 weeks (95% confidence interval 9.0–13.0). A small subset of patients maintained high levels of disease control through Week 60. This study adds to the growing body of evidence on sustained treatment response following treatment interruption.
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Reich K, Armstrong AW, Foley P, Song M, Wasfi Y, Randazzo B, et al. Efficacy and safety of guselkumab, an anti- interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017; 76: 418-431.
https://doi.org/10.1016/j.jaad.2016.11.042 DOI: https://doi.org/10.1016/j.jaad.2016.11.042
Gordon KB, Armstrong AW, Foley P, Song M, Shen YK, Li S, et al. Guselkumab Efficacy after withdrawal is associated with suppression of serum IL-23-regulated IL-17 and IL-22 in psoriasis: VOYAGE 2 Study. J Invest Dermatol 2019; 139: 2437-2446.e2431.
https://doi.org/10.1016/j.jid.2019.05.016 DOI: https://doi.org/10.1016/j.jid.2019.05.016
Blauvelt A, Papp KA, Sofen H, Augustin M, Yosipovitch G, Katoh N, et al. Continuous dosing versus interrupted therapy with ixekizumab: an integrated analysis of two phase 3 trials in psoriasis. J Eur Acad Dermatol Venereol 2017; 31: 1004-1013.
https://doi.org/10.1111/jdv.14163 DOI: https://doi.org/10.1111/jdv.14163
Kimball AB, Papp KA, Reich K, Gooderham M, Li Q, Cichanowitz N, et al. Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies. Br J Dermatol 2020; 182: 1359-1368.
https://doi.org/10.1111/bjd.18484 DOI: https://doi.org/10.1111/bjd.18484
Girolomoni G, Griffiths CE, Krueger J, Nestle FO, Nicolas JF, Prinz JC, et al. Early intervention in psoriasis and immune-mediated inflammatory diseases: a hypothesis paper. J Dermatolog Treat 2015; 26: 103-112.
https://doi.org/10.3109/09546634.2014.880396 DOI: https://doi.org/10.3109/09546634.2014.880396
Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med 2016; 375: 345-356.
https://doi.org/10.1056/NEJMoa1512711 DOI: https://doi.org/10.1056/NEJMoa1512711
Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, 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: 541-551.
https://doi.org/10.1016/S0140-6736(15)60125-8 DOI: https://doi.org/10.1016/S0140-6736(15)60125-8
Yeung J, Gooderham MJ, Grewal P, Hong CH, Lansang P, Papp KA, et al. Management of plaque psoriasis with biologic therapies in women of child-bearing potential consensus paper. J Cutan Med Surg 2020; 24: 3s-14s.
https://doi.org/10.1177/1203475420928376 DOI: https://doi.org/10.1177/1203475420928376
Gulliver SR, Gulliver W. Investigation of prevalence of biologic use and discontinuation rates in moderate-to-severe psoriasis patients in Newfoundland and Labrador using real-world data. Dermatol Ther 2021; 34: e14944.
https://doi.org/10.1111/dth.14944 DOI: https://doi.org/10.1111/dth.14944
Svedbom A, Mallbris L, Larsson P, Nikamo P, Wolk K, Kjellman P, et al. Long-term outcomes and prognosis in new-onset psoriasis. JAMA Dermatol 2021; 157: 1-8.
https://doi.org/10.1001/jamadermatol.2021.0734 DOI: https://doi.org/10.1001/jamadermatol.2021.0734
Allen PB, Olivera P, Emery P, Moulin D, Jouzeau JY, Netter P, et al. Review article: moving towards common therapeutic goals in Crohn's disease and rheumatoid arthritis. Aliment Pharmacol Ther 2017; 45: 1058-1072.
https://doi.org/10.1111/apt.13995 DOI: https://doi.org/10.1111/apt.13995
Suárez-Fariñas M, Fuentes-Duculan J, Lowes MA, Krueger JG. Resolved psoriasis lesions retain expression of a subset of disease-related genes. J Invest Dermatol 2011; 131: 391-400.
https://doi.org/10.1038/jid.2010.280 DOI: https://doi.org/10.1038/jid.2010.280
Huang YW, Tsai TF. Remission duration and long-term outcomes in patients with moderate-to-severe psoriasis treated by biologics or tofacitinib in controlled clinical trials: a 15-year single-center experience. Dermatol Ther (Heidelb) 2019; 9: 553-569.
https://doi.org/10.1007/s13555-019-0310-5 DOI: https://doi.org/10.1007/s13555-019-0310-5
Mrowietz U, Leonardi CL, Girolomoni G, Toth D, Morita A, Balki SA, et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol 2015; 73: 27-36.e21.
https://doi.org/10.1016/j.jaad.2015.04.011 DOI: https://doi.org/10.1016/j.jaad.2015.04.011
Galluzzo M, D'Adamio S, Massaro A, Piccolo A, Bianchi L, Talamonti M. Spotlight on brodalumab in the treatment of plaque psoriasis: the evidence to date. Clin Cosmet Investig Dermatol 2019; 12: 311-321.
https://doi.org/10.2147/CCID.S165605 DOI: https://doi.org/10.2147/CCID.S165605
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 Dermatology 2020; 156: 649-658.
https://doi.org/10.1001/jamadermatol.2020.0723 DOI: https://doi.org/10.1001/jamadermatol.2020.0723
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Copyright (c) 2022 Kim Papp, Carle Paul, Elise Kleyn, Yu-Huei Huang, Tsen-Fang Tsai, Christopher Schuster, Celine El Baou, Agoston Toth, Elisabeth Riedl, Ulrich Mrowietz
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