Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data.
Latin America
PURE registry
Plaque psoriasis
Real-world
Secukinumab
Journal
Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450
Informations de publication
Date de publication:
Jan 2023
Jan 2023
Historique:
received:
09
09
2022
accepted:
31
10
2022
pubmed:
11
12
2022
medline:
11
12
2022
entrez:
10
12
2022
Statut:
ppublish
Résumé
The efficacy and safety of secukinumab in patients with psoriasis has been established in randomised clinical trials. However, data on effectiveness and safety of secukinumab in Latin American real-world settings are scarce. To evaluate the effectiveness and safety of secukinumab in real-world settings in patients with psoriasis in Latin America. PURE is an ongoing multinational, prospective, observational study in patients with moderate-to-severe chronic plaque psoriasis in Canada and Latin America assessing the real-world safety and effectiveness of secukinumab and other approved therapies. The study enrolled (1:1) patients treated with secukinumab versus other approved therapies (other Tx) per local standard of care from 81 community- and hospital-based speciality sites (21 in Latin America). Here, we report effectiveness and safety outcomes with secukinumab and other Tx for plaque psoriasis for up to 12 months in a Latin American population. Overall, 187 patients were included in the analysis, 89 of whom initiated secukinumab treatment and 98 of whom received other Tx. At month 12, 84.4%, 71.1% and 53.3% of patients treated with secukinumab achieved Psoriasis Area and Severity Index (PASI) 75/90/100, respectively, compared with 66.7%, 47.9% and 29.2% of patients who received other Tx. Investigator Global Assessment (IGA) 0/1 responders in secukinumab versus other Tx were 78.3% versus 36.7% at month 3 and 81.8% versus 66.7% at month 12, respectively. Overall, the proportion of patients achieving Dermatology Life Quality Index (DLQI) 0/1 improved from 6.9% at baseline to 76.5% at month 12 in patients treated with secukinumab versus 5.6% at baseline to 54.5% at month 12 in patients on other Tx. No unexpected adverse events were reported during the 12-month observation period. Secukinumab demonstrated real-world effectiveness and improved dermatology quality-of-life in chronic plaque psoriasis patients from Latin America. PURE: NCT02786186.
Sections du résumé
BACKGROUND
BACKGROUND
The efficacy and safety of secukinumab in patients with psoriasis has been established in randomised clinical trials. However, data on effectiveness and safety of secukinumab in Latin American real-world settings are scarce.
OBJECTIVES
OBJECTIVE
To evaluate the effectiveness and safety of secukinumab in real-world settings in patients with psoriasis in Latin America.
METHODS
METHODS
PURE is an ongoing multinational, prospective, observational study in patients with moderate-to-severe chronic plaque psoriasis in Canada and Latin America assessing the real-world safety and effectiveness of secukinumab and other approved therapies. The study enrolled (1:1) patients treated with secukinumab versus other approved therapies (other Tx) per local standard of care from 81 community- and hospital-based speciality sites (21 in Latin America). Here, we report effectiveness and safety outcomes with secukinumab and other Tx for plaque psoriasis for up to 12 months in a Latin American population.
RESULTS
RESULTS
Overall, 187 patients were included in the analysis, 89 of whom initiated secukinumab treatment and 98 of whom received other Tx. At month 12, 84.4%, 71.1% and 53.3% of patients treated with secukinumab achieved Psoriasis Area and Severity Index (PASI) 75/90/100, respectively, compared with 66.7%, 47.9% and 29.2% of patients who received other Tx. Investigator Global Assessment (IGA) 0/1 responders in secukinumab versus other Tx were 78.3% versus 36.7% at month 3 and 81.8% versus 66.7% at month 12, respectively. Overall, the proportion of patients achieving Dermatology Life Quality Index (DLQI) 0/1 improved from 6.9% at baseline to 76.5% at month 12 in patients treated with secukinumab versus 5.6% at baseline to 54.5% at month 12 in patients on other Tx. No unexpected adverse events were reported during the 12-month observation period.
CONCLUSION
CONCLUSIONS
Secukinumab demonstrated real-world effectiveness and improved dermatology quality-of-life in chronic plaque psoriasis patients from Latin America.
TRIAL REGISTRATION
BACKGROUND
PURE: NCT02786186.
Identifiants
pubmed: 36496547
doi: 10.1007/s13555-022-00849-0
pii: 10.1007/s13555-022-00849-0
pmc: PMC9823177
doi:
Banques de données
ClinicalTrials.gov
['NCT02786186']
Types de publication
Journal Article
Langues
eng
Pagination
269-283Informations de copyright
© 2022. The Author(s).
Références
Fry L. An atlas of psoriasis. 2nd ed. London: Taylor & Francis; 2005.
Hernández-Vásquez AML, Larrea N, Ciapponi A. Psoriasis in Latin America and the Caribbean: a systematic review. J Eur Acad Dermatol Venereol. 2017;31:1991–8.
doi: 10.1111/jdv.14393
Sbidian E, Chaimani A, Garcia-Doval I, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2017;12;CD011535.
Sbidian E, Chaimani A, Afach S, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2020;1;CD011535.
Gottlieb AB, Wu JJ, Griffiths CEM, et al. Clinical efficacy and safety of secukinumab in patients with psoriasis and comorbidities: pooled analysis of 4 phase 3 clinical trials. J Dermatolog Treat. 2020;33:1–9.
Baeten D, Sieper J, Braun J, et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med. 2015;373:2534–48.
doi: 10.1056/NEJMoa1505066
Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis–results of two phase 3 trials. N Engl J Med. 2014;371:326–38.
doi: 10.1056/NEJMoa1314258
McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137–46.
doi: 10.1016/S0140-6736(15)61134-5
Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015;73:400–9.
doi: 10.1016/j.jaad.2015.05.013
Adsit SZE, Sofen H, et al. Secukinumab is efficacious and safe in Hispanic patients with moderate-to-severe plaque psoriasis: pooled analysis of four phase 3 trials. Adv Ther. 2017;34:1327–39.
doi: 10.1007/s12325-017-0521-z
Bissonnette R, Luger T, Thaci D, et al. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017;177:1033–42.
doi: 10.1111/bjd.15706
Strober BE, Germino R, Guana A, et al. US real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry. J Dermatolog Treat. 2020;31:333–41.
doi: 10.1080/09546634.2019.1603361
Yiu ZZN, Mason KJ, Hampton PJ, et al. Drug survival of adalimumab, ustekinumab and secukinumab in patients with psoriasis: a prospective cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Br J Dermatol. 2020;183:294–302.
doi: 10.1111/bjd.18981
DE Augustin M, Mrowietz U, et al. Secukinumab treatment leads to normalization of quality of life and disease symptoms in psoriasis patients with or without prior systemic psoriasis therapy: the PROSE study results. J Eur Acad Dermatol Venereol. 2021;35:431–40.
doi: 10.1111/jdv.16632
Thaçi DKA, von Kiedrowski R, et al. Secukinumab is effective in treatment of moderate-to-severe plaque psoriasis: real-life effectiveness and safety from the PROSPECT study. J Eur Acad Dermatol Venereol. 2020;34:310–8.
doi: 10.1111/jdv.15962
Papp KA, Gooderham M, Beecker J, et al. Rationale, objectives and design of PURE, a prospective registry of patients with moderate to severe chronic plaque psoriasis in Canada and Latin America. BMC Dermatol. 2019;19:9.
doi: 10.1186/s12895-019-0087-3
Körber ATD, von Kiedrowski R, et al. Secukinumab treatment of moderate to severe plaque psoriasis in routine clinical care: real-life data of prior and concomitant use of psoriasis treatments from the PROSPECT study. J Eur Acad Dermatol Venereol. 2018;32:411–9.
doi: 10.1111/jdv.14604
Momose M, Asahina A, Umezawa Y, Nakagawa H. Long-term clinical efficacy and safety of secukinumab for Japanese patients with psoriasis: a single-center experience. J Dermatol. 2018;45:318–21.
doi: 10.1111/1346-8138.14145
Galluzzo M, Talamonti M, De Simone C, et al. Secukinumab in moderate-to-severe plaque psoriasis: a multi-center, retrospective, real-life study up to 52 weeks observation. Expert Opin Biol Ther. 2018;18:727–35.
doi: 10.1080/14712598.2018.1481503
Notario J, Deza G, Vilarrasa E, et al. Treatment of patients with plaque psoriasis with secukinumab in a real-life setting: a 52-week, multicenter, retrospective study in Spain. J Dermatolog Treat. 2019;30:424–9.
doi: 10.1080/09546634.2018.1528000
Megna M, Di Costanzo L, Argenziano G, et al. Effectiveness and safety of secukinumab in Italian patients with psoriasis: an 84 week, multicenter, retrospective real-world study. Expert Opin Biol Ther. 2019;19:855–61.
doi: 10.1080/14712598.2019.1622678
Bissonnette RLT, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32:1507–14.
doi: 10.1111/jdv.14878
Galluzzo M, D’Adamio S, Silvaggio D, Lombardo P, Bianchi L, Talamonti M. In which patients the best efficacy of secukinumab? Update of a real-life analysis after 136 weeks of treatment with secukinumab in moderate-to-severe plaque psoriasis. Expert Opin Biol Ther. 2020;20:173–82.
doi: 10.1080/14712598.2020.1708897
Bagel J, Blauvelt A, Nia J, et al. 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 Eur Acad Dermatol Venereol. 2021;35:135–42.
doi: 10.1111/jdv.16558
Blauvelt A, Reich K, Tsai TF, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017;76(60–69): e69.
Augustin M, Dauden E, Mrowietz U, et al. Secukinumab treatment leads to normalization of quality of life and disease symptoms in psoriasis patients with or without prior systemic psoriasis therapy: the PROSE study results. J Eur Acad Dermatol Venereol. 2021;35:431–40.
doi: 10.1111/jdv.16632
Mrowietz U, Leonardi CL, Girolomoni G, 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.