Long-Term Safety of Risankizumab in Patients with Psoriatic Disease: A Comprehensive Analysis from Clinical Trials.
IL-23
Long-term safety
Psoriasis
Psoriatic arthritis
Risankizumab
Journal
Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450
Informations de publication
Date de publication:
17 Aug 2024
17 Aug 2024
Historique:
received:
14
06
2024
accepted:
10
07
2024
medline:
17
8
2024
pubmed:
17
8
2024
entrez:
17
8
2024
Statut:
aheadofprint
Résumé
Risankizumab has demonstrated a favourable safety profile in patients with psoriatic disease (moderate-to-severe psoriasis [PsO] and psoriatic arthritis [PsA]). We evaluated the long-term safety of risankizumab in psoriatic disease. Long-term safety was evaluated by analysing data from 20 (phase 1-4) clinical trials for plaque PsO and four (phase 2-3) trials for PsA. Treatment-emergent adverse events (TEAEs) and AEs in areas of special interest were reported among patients receiving ≥ 1 dose of risankizumab. Exposure-adjusted event rates were presented as events (E) per 100 patient-years (PY). The long-term safety data analyses included 3658 patients with PsO (13,329.3 PY) and 1542 patients with PsA (3803.0 PY). The median (range) treatment duration for patients with PsO and PsA was 4.1 (0.2-8.8) years and 2.8 (0.2-4.0) years, respectively. In the PsO population, rates of TEAEs, serious AEs and AEs leading to discontinuation were 145.5 E/100 PY, 7.4 E/100 PY and 1.9 E/100 PY, respectively; in the PsA population, these rates were 142.6 E/100 PY, 8.6 E/100 PY, and 1.8 E/100 PY, respectively. The rates of serious infections (excluding COVID-19-related infections) in the PsO and PsA populations were 1.2 and 1.4 E/100 PY, respectively. The rates of opportunistic infections (excluding tuberculosis and herpes zoster) were low (< 0.1 E/100 PY) in both populations. The rates of both nonmelanoma skin cancer (NMSC) and malignant tumours excluding NMSC were 0.6 and 0.5 E/100 PY in PsO and PsA, respectively, which are within the benchmarks of prior epidemiological studies. Adjudicated major cardiovascular event rates were 0.5 E/100 PY in PsO and 0.3 E/100 PY in PsA, which are within the epidemiologic reference benchmarks for both indications. No additional safety concerns were identified with this long-term exposure. The results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns and similar safety profiles among both PsO and PsA populations.
Identifiants
pubmed: 39153059
doi: 10.1007/s13555-024-01238-5
pii: 10.1007/s13555-024-01238-5
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2024. The Author(s).
Références
Korman NJ, Malatestinic W, Goldblum OM, et al. Assessment of the benefit of achieving complete versus almost complete skin clearance in psoriasis: a patient’s perspective. J Dermatol Treat. 2022;33:733–9.
doi: 10.1080/09546634.2020.1772454
Kavanaugh A, Gottlieb A, Morita A, et al. The contribution of joint and skin improvements to the health-related quality of life of patients with psoriatic arthritis: a post hoc analysis of two randomised controlled studies. Ann Rheum Dis. 2019;78:1215.
doi: 10.1136/annrheumdis-2018-215003
pubmed: 31113794
Gooderham M, Pinter A, Ferris LK, et al. Long-term, durable, absolute Psoriasis Area and Severity Index and health-related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate-to-severe plaque psoriasis. J Eur Acad Dermatol. 2022;36:855–65.
doi: 10.1111/jdv.18010
Kristensen LE, Soliman AM, Padilla B, Papp K, Ostor A. POS1524 Durable clinically-meaningful improvements in health-related quality of life, fatigue, pain, and work productivity among patients with active psoriatic arthritis treated with risankizumab at week 100. Science. 2023;2:1123.
Singh S, Kroe-Barrett RR, Canada KA, et al. Selective targeting of the IL23 pathway: generation and characterization of a novel high-affinity humanized anti-IL23A antibody. MAbs. 2015;7:778–91. https://doi.org/10.1080/19420862.2015.1032491 .
Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2022;62:2113–21.
doi: 10.1093/rheumatology/keac607
Östör A, den Bosch FV, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). 2022;62:2122–9.
doi: 10.1093/rheumatology/keac605
Armstrong AW, Soliman AM, Betts KA, et al. Long-term benefit-risk profiles of treatments for moderate-to-severe plaque psoriasis: a network meta-analysis. Dermatol Ther. 2021;12:167–84.
doi: 10.1007/s13555-021-00647-0
Megna M, Ruggiero A, Battista T, Marano L, Cacciapuoti S, Potestio L. Long-term efficacy and safety of risankizumab for moderate to severe psoriasis: a 2-year real-life retrospective study. J Clin Med. 2023;12:3233.
doi: 10.3390/jcm12093233
pubmed: 37176672
pmcid: 10179221
Gordon KB, Lebwohl M, Papp KA, Bachelez H, Wu JJ, Langley RG, et al. Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2022;186:466–75.
doi: 10.1111/bjd.20818
pubmed: 34652810
United Nations Department of Economic and Social Affairs Population Division. World population prospects 2019; mortality data. https://population.un.org/wpp2019/Download/Standard/Mortality/
Papp K, Gottlieb AB, Naldi L, et al. Safety surveillance for ustekinumab and other psoriasis treatments from the psoriasis longitudinal assessment and registry (PSOLAR). J Drugs Dermatol. 2015;14:706–14.
Ritchlin CT, Stahle M, Poulin Y, et al. Serious infections in patients with self-reported psoriatic arthritis from the psoriasis longitudinal assessment and registry (PSOLAR) treated with biologics. BMC Rheumatol. 2019;3:52.
Papp KA, Langholff W. Safety surveillance for ustekinumab and other psoriasis treatments from the psoriasis longitudinal assessment and registry (PSOLAR) errata. J Drugs Dermatol. 2020;19:571–2.
Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Cohort study of malignancies and hospitalized infectious events in treated and untreated patients with psoriasis and a general population in the United States. Br J Dermatol. 2015;173:1183–90
Vaengebjerg S, Skov L, Egeberg A, Loft ND. Prevalence, incidence, and risk of cancer in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis. JAMA Dermatol. 2020;156:421–9.
Li L, Hagberg KW, Peng M, Shah K, Paris M, Jick S. Rates of cardiovascular disease and major adverse cardiovascular events in patients with psoriatic arthritis compared to patients without psoriatic arthritis. J Clin Rheumatol. 2015;21:405–10.
Al-Janabi A, Warren R. Update on risankizumab for the treatment of moderate to severe psoriasis. Expert Opin Biol Ther. 2020;20:1245–51.
doi: 10.1080/14712598.2020.1822813
pubmed: 32933320
Ibba L, Gargiulo L, Vignoli CA, et al. Safety of anti-IL-23 drugs in patients with moderate-to-severe plaque psoriasis and previous tuberculosis infection: a monocentric retrospective study. J Dermatol Treat. 2023;34:2241585.
doi: 10.1080/09546634.2023.2241585
Torres T, Chiricozzi A, Puig L, et al. Treatment of psoriasis patients with latent tuberculosis using IL-17 and IL-23 inhibitors: a retrospective, multinational, multicentre study. Am J Clin Dermatol. 2024;25:333–42.
doi: 10.1007/s40257-024-00845-4
pubmed: 38265746
pmcid: 10867072
Östör A, den Bosch FV, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the KEEPsAKE 2 randomized clinical trial. Rheumatol Ther. 2024;2:1–16.
Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024;11:617–32.
doi: 10.1007/s40744-024-00654-5
pubmed: 38498141
pmcid: 11111619
Smith CH, Anstey AV, Barker JNWN, et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009. Br J Dermatol. 2009;161:987–1019.
doi: 10.1111/j.1365-2133.2009.09505.x
pubmed: 19857207
Nast A, Gisondi P, Ormerod AD, et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris—Update 2015—Short version—EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29:2277–94.
doi: 10.1111/jdv.13354
pubmed: 26481193
Yim KM, Armstrong AW. Updates on cardiovascular comorbidities associated with psoriatic diseases: epidemiology and mechanisms. Rheumatol Int. 2017;37:97–105.
Ogdie A, Yu Y, Haynes K, et al. Risk of major cardiovascular events in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: a population-based cohort study. Ann Rheum Dis. 2015;74:326–32.
Sinvhal R, Krueger WS, Kilpatrick RD, Coppola D. Letter to the editor concerning the article: “Potential cerebrovascular accident signal for risankizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS).” Br J Clin Pharmacol. 2023;89:2639–41.
Egeberg A, Thyssen JP. Increased reporting of cerebrovascular accidents with use of risankizumab observed in the food and drug administration adverse events reporting system (FAERS). Br J Dermatol. 2023;188:793–4.
Woods RH. Potential cerebrovascular accident signal for risankizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS). Br J Clin Pharmacol. 2022;89:2386–95.
Lukmanji A, Basmadjian RB, Vallerand IA, Patten SB, Tang KL. Risk of depression in patients with psoriatic disease: a systematic review and meta-analysis. J Cutan Med Surg. 2020;25:257–70.
doi: 10.1177/1203475420977477
pubmed: 33263264
Augustin M, Lambert J, Zema C, Thompson EHZ, Yang M, Wu EQ, et al. Effect of risankizumab on patient-reported outcomes in moderate to severe psoriasis. JAMA Dermatol. 2020;156:1344–53.
doi: 10.1001/jamadermatol.2020.3617
pubmed: 33052382
European Medicines Agency. Assessment report. Skyrizi. 2021. https://www.ema.europa.eu/en/documents/variation-report/skyrizi-h-c-004759-ii-0014-epar-assessment-report-variation_en.pdf . Accessed 17 Apr 2024
Strober B, Gooderham M, de Jong EMGJ, et al. Depressive symptoms, depression, and the effect of biologic therapy among patients in psoriasis longitudinal assessment and registry (PSOLAR). J Am Acad Dermatol. 2018;78:70–80.
doi: 10.1016/j.jaad.2017.08.051
pubmed: 29102053
Wu JJ, Penfold RB, Primatesta P, et al. The risk of depression, suicidal ideation and suicide attempt in patients with psoriasis, psoriatic arthritis or ankylosing spondylitis. J Eur Acad Dermatol Venereol. 2017;31(7):1168-75.