Real-World Data on Brodalumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis: An Observational Study from the Czech Republic BIOREP Registry

. 2024 Oct ; 41 (10) : 3951-3971. [epub] 20240829

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu časopisecké články, pozorovací studie, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid39207667
Odkazy

PubMed 39207667
PubMed Central PMC11399213
DOI 10.1007/s12325-024-02952-4
PII: 10.1007/s12325-024-02952-4
Knihovny.cz E-zdroje

INTRODUCTION: The aim of this observational, multicenter study was to assess the real-world use of brodalumab for the treatment of moderate-to-severe plaque psoriasis in patients in the Czech Republic, using data from the BIOREP registry. METHODS: The study included 273 patients aged ≥ 18 years with moderate-to-severe psoriasis who received brodalumab. Endpoints were drug survival (time from treatment initiation to discontinuation), effectiveness [Psoriasis Area and Severity Index (PASI)], and health-related quality-of-life [Dermatology Life Quality Index (DLQI)]. RESULTS: Predicted drug survival probability was 92.4% [95% confidence interval (CI): 89.1, 95.7%] at 6 months and 84.2% (95% CI 79.5, 89.1%) at 12 months; this was maintained at 24 months [80.4% (95% CI 74.5, 86.8%)]. Younger age, higher body mass index, and no previous biologic treatment were significantly associated with longer drug survival. Absolute PASI ≤ 3 after 3 months was achieved by 89.8% of patients; 92.4%, 77.8%, and 59.1% reached PASI 75, PASI 90, and PASI 100, respectively. After 12 months, 96.5% of 141 patients had an absolute PASI ≤ 3. The proportion of patients achieving DLQI 0/1 was 87.3% at 12 months. CONCLUSION: This study demonstrated high and sustained drug survival with high rates of skin clearance and improved quality of life in patients with relatively severe disease treated with brodalumab. Improvements were observed as early as 3 months post-treatment initiation and were sustained for up to 24 months in a real-life setting.

Zobrazit více v PubMed

Gisondi P, Bellinato F, Girolomoni G, Albanesi C. Pathogenesis of chronic plaque psoriasis and its intersection with cardio-metabolic comorbidities. Front Pharmacol. 2020;11:117. 10.3389/fphar.2020.00117 PubMed DOI PMC

Lambert J, Hansen JB, Sohrt A, Puig L. Dermatology life quality index in patients with moderate-to-severe plaque psoriasis treated with brodalumab or ustekinumab. Dermatol Ther (Heidelb). 2021;11(4):1265–75. 10.1007/s13555-021-00545-5 PubMed DOI PMC

Pinter A, Bonnekoh B, Hadshiew IM, Zimmer S. Brodalumab for the treatment of moderate-to-severe psoriasis: case series and literature review. Clin Cosmet Investig Dermatol. 2019;12:509–17. 10.2147/CCID.S211938 PubMed DOI PMC

Gambardella A, Licata G, Sohrt A. Dose adjustment of biologic treatments for moderate-to-severe plaque psoriasis in the real world: a systematic review. Dermatol Ther (Heidelb). 2021;11(4):1141–56. 10.1007/s13555-021-00559-z PubMed DOI PMC

Rønholt K, Iversen L. Old and new biological therapies for psoriasis. Int J Mol Sci. 2017;18(11):2297. 10.3390/ijms18112297 PubMed DOI PMC

Sawyer L, Fotheringham I, Wright E, Yasmeen N, Gibbons C, Holmen MA. The comparative efficacy of brodalumab in patients with moderate-to-severe psoriasis: a systematic literature review and network meta-analysis. J Dermatolog Treat. 2018;29(6):557–68. 10.1080/09546634.2018.1427205 PubMed DOI

Fargnoli MC, Bardazzi F, Bianchi L, Dapavo P, Fabbrocini G, Gisondi P, et al. Brodalumab for the treatment of moderate-to-severe psoriasis: an expert delphi consensus statement. J Clin Med. 2023;12(10):3545. 10.3390/jcm12103545 PubMed DOI PMC

Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, et al. Phase 3 Studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318–28. 10.1056/NEJMoa1503824 PubMed DOI

Papp K, Menter A, Leonardi C, Soung J, Weiss S, Pillai R, et al. Long-term efficacy and safety of brodalumab in psoriasis through 120 weeks and after withdrawal and retreatment: subgroup analysis of a randomized phase III trial (AMAGINE-1). Br J Dermatol. 2020;183(6):1037–48. 10.1111/bjd.19132 PubMed DOI PMC

Papp KA, Reich K, Paul C, Blauvelt A, Baran W, Bolduc C, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016;175(2):273–86. 10.1111/bjd.14493 PubMed DOI

Pinter A, Hoffmann M, Reich K, Augustin M, Kaplan K, Gudjónsdóttir SD, et al. A phase 4, randomized, head-to-head trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate-to-severe plaque psoriasis (CHANGE). J Eur Acad Dermatol Venereol. 2021;35(3):701–11. 10.1111/jdv.16932 PubMed DOI

Peters U, Turner B, Alvarez D, Murray M, Sharma A, Mohan S, et al. Considerations for embedding inclusive research principles in the design and execution of clinical trials. Ther Innov Regul Sci. 2023;57(2):186–95. 10.1007/s43441-022-00464-3 PubMed DOI PMC

Dang A. Real-world evidence: a primer. Pharmaceut Med. 2023;37(1):25–36. PubMed PMC

Cacciapuoti S, Potestio L, Guerrasio G, Fabbrocini G, Scalvenzi M, Ruggiero A, et al. Effectiveness of brodalumab in patients with moderate-to-severe plaque psoriasis located in difficult-to-treat areas. Clin Cosmet Investig Dermatol. 2023;16:2637–44. 10.2147/CCID.S423234 PubMed DOI PMC

Caldarola G, Galluzzo M, Bernardini N, Botti E, De Luca E, De Simone C, et al. Long-term effectiveness of brodalumab for the treatment of moderate-to-severe psoriasis: a real-life multicenter study of up to 3 years in a real-life italian cohort. Dermatol Pract Concept. 2024;14(2):e2024152. 10.5826/dpc.1402a152 PubMed DOI PMC

Megna M, Potestio L, Camela E, Fabbrocini G, Ruggiero A. Ixekizumab and brodalumab indirect comparison in the treatment of moderate to severe psoriasis: results from an Italian single-center retrospective study in a real-life setting. Dermatol Ther. 2022;35(9): e15667. 10.1111/dth.15667 PubMed DOI PMC

Rigopoulos D, Tampouratzi E, Angelakopoulos C, Apalla Z, Barkis I, Georgiou S, et al. Real-world data on the effectiveness of brodalumab in patients with moderate-to severe plaque psoriasis in the Greek clinical setting (the Br IDGE study). J Eur Acad Dermatol Venereol. 2024;38(6):1121–30. 10.1111/jdv.19816 PubMed DOI

Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763–74. 10.1007/s12325-018-0805-y PubMed DOI PMC

Mason KJ, Barker J, Smith CH, Hampton PJ, Lunt M, McElhone K, et al. Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR. JAMA Dermatol. 2018;154(5):581–8. 10.1001/jamadermatol.2018.0183 PubMed DOI PMC

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 (Heidelb). 2021;11(4):1345–55. 10.1007/s13555-021-00556-2 PubMed DOI PMC

Kojanova M, Fialova J, Cetkovska P, Gkalpakiotis S, Jircikova J, Dolezal T, et al. Characteristics and risk profile of psoriasis patients included in the Czech national registry BIOREP and a comparison with other registries. Int J Dermatol. 2017;56(4):428–34. 10.1111/ijd.13543 PubMed DOI

Mourad AI, Gniadecki R. Biologic drug survival in psoriasis: a systematic review and comparative meta-analysis. Front Med (Lausanne). 2020;7: 625755. 10.3389/fmed.2020.625755 PubMed DOI PMC

Kojanova M, Cetkovska P, Strosova D, Fialova J, Arenberger P, Dolezal T, et al. Real-world evidence from more than 1000 patients treated with adalimumab for moderate-to-severe psoriasis in the Czech Republic. Dermatol Ther (Heidelb). 2021;11(2):543–53. 10.1007/s13555-021-00499-8 PubMed DOI PMC

Busard CI, Cohen AD, Wolf P, Gkalpakiotis S, Cazzaniga S, Stern RS, et al. Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries. J Eur Acad Dermatol Venereol. 2018;32(2):245–53. 10.1111/jdv.14583 PubMed DOI

Torres T, Puig L, Vender R, Lynde C, Piaserico S, Carrascosa JM, et al. Drug survival of IL-12/23, IL-17 and IL-23 inhibitors for psoriasis treatment: a retrospective multi-country, multicentric cohort study. Am J Clin Dermatol. 2021;22(4):567–79. 10.1007/s40257-021-00598-4 PubMed DOI

Cerveró AD, Cardona G, Morales A, Carrascosa M, Ferrandiz C, Guomundsdottir F, et al. 4CPS-041 drug survival of biologic therapies for the treatment of psoriasis. Eur J Hosp Pharm. 2018;25(Suppl 1):A59-60. 10.1136/ejhpharm-2018-eahpconf.132. (eCollection 2018).10.1136/ejhpharm-2018-eahpconf.132 DOI

Kojanova M, Fialova J, Cetkovska P, Dolezal T, Lomicova I, Arenberger P, et al. Demographic data, comorbidities, quality of life, and survival probability of biologic therapy associated with sex-specific differences in psoriasis in the Czech Republic. Dermatol Ther. 2021;34(2): e14849. 10.1111/dth.14849 PubMed DOI

Mourad A, Straube S, Armijo-Olivo S, Gniadecki R. Factors predicting persistence of biologic drugs in psoriasis: a systematic review and meta-analysis. Br J Dermatol. 2019;181(3):450–8. 10.1111/bjd.17738 PubMed DOI

Pogácsás L, Borsi A, Takács P, Remenyik É, Kemény L, Kárpáti S, et al. Long-term drug survival and predictor analysis of the whole psoriatic patient population on biological therapy in Hungary. J Dermatol Treat. 2017;28(7):635–41.10.1080/09546634.2017.1329504 PubMed DOI

Zeb L, Mhaskar R, Lewis S, Patel NS, Sadhwani D, Patel N, et al. Real-world drug survival and reasons for treatment discontinuation of biologics and apremilast in patients with psoriasis in an academic center. Dermatol Ther. 2021;34(2): e14826. 10.1111/dth.14826 PubMed DOI

Fargnoli MC, Esposito M, Dapavo P, Parodi A, Rossi M, Tiberio R, et al. Brodalumab for the treatment of moderate-to-severe plaque-type psoriasis: a real-life, retrospective 24-week experience. J Eur Acad Dermatol Venereol. 2021;35(3):693–700. 10.1111/jdv.16931 PubMed DOI

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...