Dose reduction is a feasible strategy in patients with plaque psoriasis who achieve sustained response with secukinumab: a retrospective, multicenter cohort study in daily practice setting
Esteban Daudén MD, PhD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Both co-authors contributed equally to this study.
Search for more papers by this authorElena Escario MD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Both co-authors contributed equally to this study.
Search for more papers by this authorCorresponding Author
Luisa Martos-Cabrera MD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Both co-authors contributed equally to this study.
Correspondence
Luisa Martos-Cabrera, MD
Hospital Universitario de la Princesa
Calle Diego de León, 62
Madrid 28006
Spain
E-mail: [email protected]
Search for more papers by this authorSusana Armesto MD
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Search for more papers by this authorEnrique Herrera-Acosta MD
Hospital Virgen de la Victoria, Málaga, Spain
Search for more papers by this authorDavid Vidal MD
Hospital de Sant Joan Despí Moisés Broggi, Barcelona, Spain
Search for more papers by this authorEva Vilarrasa MD
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Search for more papers by this authorRaquel Rivera MD
Hospital Universitario 12 de Octubre, Madrid, Spain
Search for more papers by this authorPablo de la Cueva MD, PhD
Hospital Universitario Infanta Leonor, Madrid, Spain
Search for more papers by this authorFerran Ballesca MD
Hospital Universitario Germans Trias i Pujol, Barcelona, Spain
Search for more papers by this authorIsabel Belinchón MD
Hospital General Universitario de Alicante – ISABIAL, Alicante, Spain
Search for more papers by this authorGregorio Carretero MD
Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Spain
Search for more papers by this authorLourdes Rodríguez MD
Hospital Universitario Virgen del Rocío, Sevilla, Spain
Search for more papers by this authorJ. Pujol-Montcusí MD
Hospital Universitario de Tarragona "Joan XXIII", Tarragona, Spain
Search for more papers by this authorLaura Salgado MD
Complejo Hospitalario Universitario, Pontevedra, Spain
Search for more papers by this authorAntonio Sahuquillo-Torralba MD
Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain
Search for more papers by this authorPablo Coto-Segura MD
Hospital Vital Alvarez-Buylla de Mieres, Asturias, Spain
Search for more papers by this authorOfelia Baniandrés MD
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Search for more papers by this authorJosep Riera-Monroig MD
Hospital Clínic i Provincial, Barcelona, Spain
Search for more papers by this authorMar Llamas-Velasco MD, PhD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Search for more papers by this authorEsteban Daudén MD, PhD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Both co-authors contributed equally to this study.
Search for more papers by this authorElena Escario MD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Both co-authors contributed equally to this study.
Search for more papers by this authorCorresponding Author
Luisa Martos-Cabrera MD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Both co-authors contributed equally to this study.
Correspondence
Luisa Martos-Cabrera, MD
Hospital Universitario de la Princesa
Calle Diego de León, 62
Madrid 28006
Spain
E-mail: [email protected]
Search for more papers by this authorSusana Armesto MD
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Search for more papers by this authorEnrique Herrera-Acosta MD
Hospital Virgen de la Victoria, Málaga, Spain
Search for more papers by this authorDavid Vidal MD
Hospital de Sant Joan Despí Moisés Broggi, Barcelona, Spain
Search for more papers by this authorEva Vilarrasa MD
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Search for more papers by this authorRaquel Rivera MD
Hospital Universitario 12 de Octubre, Madrid, Spain
Search for more papers by this authorPablo de la Cueva MD, PhD
Hospital Universitario Infanta Leonor, Madrid, Spain
Search for more papers by this authorFerran Ballesca MD
Hospital Universitario Germans Trias i Pujol, Barcelona, Spain
Search for more papers by this authorIsabel Belinchón MD
Hospital General Universitario de Alicante – ISABIAL, Alicante, Spain
Search for more papers by this authorGregorio Carretero MD
Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Spain
Search for more papers by this authorLourdes Rodríguez MD
Hospital Universitario Virgen del Rocío, Sevilla, Spain
Search for more papers by this authorJ. Pujol-Montcusí MD
Hospital Universitario de Tarragona "Joan XXIII", Tarragona, Spain
Search for more papers by this authorLaura Salgado MD
Complejo Hospitalario Universitario, Pontevedra, Spain
Search for more papers by this authorAntonio Sahuquillo-Torralba MD
Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain
Search for more papers by this authorPablo Coto-Segura MD
Hospital Vital Alvarez-Buylla de Mieres, Asturias, Spain
Search for more papers by this authorOfelia Baniandrés MD
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Search for more papers by this authorJosep Riera-Monroig MD
Hospital Clínic i Provincial, Barcelona, Spain
Search for more papers by this authorMar Llamas-Velasco MD, PhD
Hospital Universitario de la Princesa. Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain
Search for more papers by this authorFunding source: None.
Abstract
Background
Biological therapy dose modification is a common practice in the long-term treatment of plaque psoriasis.
Objective
The objective of the study was to determine prevalence, characteristics of patients, effectiveness, treatment survival of secukinumab dose reduction (SEC-DR) strategy and assess its safety and cost implications.
Methods
A retrospective, observational, multicenter cohort study was conducted in patients with plaque psoriasis treated with secukinumab and up to 2 years of follow-up.
Results
In 63/347 patients with an initial standard dose regimen, SEC-DR was tried at any moment in 18.2% of them after sustained response. In 51 patients, the interval between administrations was increased while in 12 patients, monthly dose was reduced to 150 mg. Successful SEC-DR was achieved in 77.8% of the patients, with sustained PASI response to the end of the study. Survival of secukinumab treatment and safety profile were not compromised by DR. The use of DR saved 33% of the cost, including failures in which standard treatment was resumed.
Limitations
The proper of the study designed and the arbitrary definition of “DR success.”
Conclusion
Off-label SEC-DR strategy was used in patients with sustained response to standard dose regimen; this strategy showed long-term efficacy without compromising treatment survival or worsening the safety profile while also being cost saving.
Supporting Information
Filename | Description |
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ijd16915-sup-0001-TableS1.docxWord 2007 document , 17.2 KB |
Table S1. Comparison of treatment response (mean absolute PASI and % of PASI reduction) between patients with and without dose reduction. |
ijd16915-sup-0002-TableS2.docxWord 2007 document , 19.6 KB |
Table S2. Logistic regression analysis of variables associated with success of dose reduction. |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
References
- 1Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, et al. Secukinumab in plaque psoriasis- results of two phase 3 trials. N Engl J Med. 2014; 371(4): 326–338.
- 2Thaçi D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo 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(3): 400–409.
- 3Bissonnette R, Luger T, Thaçi D, Toth D, Lacombe A, Xia S, 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(9): 1507–1514.
- 4Ruiz-Villaverde R, Rodriguez-Fernandez-Freire L, Galán-Gutierrez M, Armario-Hita JC, Martinez-Pilar L. Drug survival, discontinuation rates, and safety profile of secukinumab in real-world patients: a 152-week, multicenter, retrospective study. Int J Dermatol. 2020; 59(5): 633–639.
- 5Baniandrés O, Rodríguez-Soria VJ, Romero-Jiménez RM, Suárez R. Dose modification in biologic therapy for moderate to severe psoriasis: a descriptive analysis in a clinical practice setting. Actas Dermosifiliogr. 2015; 106(7): 569–577.
- 6Carrascosa J-M, Garcia-Doval I, Pérez-Zafrilla B, Carretero G, Vanaclocha F, Daudén E. Use of off-label doses is frequent in biologic therapy for moderate to severe psoriasis: a cross-sectional study in clinical practice. J Dermatolog Treat. 2015; 26(6): 502–506.
- 7Esposito M, Gisondi P, Conti A, Giunta A, Del Giglio M, Di Mercurio M, et al. Dose adjustment of biologic therapies for psoriasis in dermatological practice: a retrospective study. J Eur Acad Dermatol Venereol. 2017; 31(5): 863–869.
- 8Gambardella 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. 2021; 11(4): 1141–1156.
10.1007/s13555-021-00559-z Google Scholar
- 9Muñoz-Santos C, Sola-Ortigosa J, Guilabert A. Treatment optimization with secukinumab 150 mg for moderate-to-severe psoriasis in clinical practice: a single-center open-label 52-week study. Int J Dermatol. 2018; 57(5): 615–617.
- 10Phung M, Ighani A, Georgakopoulos JR, Vender R, Giroux L, Lansang P, et al. Off-label high-dose secukinumab for the treatment of moderate-to-severe psoriasis. J Cutan Med Surg. 2019; 23(4): 391–393.
- 11Reich K, Puig L, Szepietowski JC, Paul C, Lacour JP, Tsianakas A, et al. Secukinumab dosing optimization in patients with moderate-to-severe plaque psoriasis: results from the randomized, open-label OPTIMISE study. Br J Dermatol. 2019; 182(2): 304–315.
- 12Daudén E, Puig L, Ferrándiz C, Sánchez-Carazo JL, Hernanz-Hermosa JM. Consensus document on the evaluation and treatment of moderate-to-severe psoriasis: Psoriasis Group of the Spanish Academy of Dermatology and Venereology. J Eur Acad Dermatol Venereol. 2016; 30: 1–18.
- 13Hansel K, Bianchi L, Lanza F, Bini V, Stingeni L. Adalimumab dose tapering in psoriasis: predictive factors for maintenance of complete clearance. Acta Derm Venereol. 2017; 97(3): 346–350.
- 14Gisondi P, Rovaris M, Piaserico S, Girolomoni G. Efficacy of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Br J Dermatol. 2019; 182(1): 175–179.
- 15Costa-Scharplatz M, Lang A, Gustavsson A, Fasth A. Cost-effectiveness of secukinumab compared to ustekinumab in patients with psoriasis from a swedish health care perspective. Value Health. 2015; 18(7): A422.
- 16Puig L, Notario J, Jiménez-Morales A, Moreno-Ramírez D, López-Ferrer A, Gozalbo I, et al. Secukinumab is the most efficient treatment for achieving clear skin in psoriatic patients: a cost-consequence study from the Spanish National Health Service. J Dermatol Treat. 2017; 28(7): 623–630.
- 17Al Sawah S, Foster SA, Burge R, Amato D, Schacht A, Zhu B, et al. Cost per additional responder for ixekizumab and other FDA-approved biologics in moderate-to-severe plaque psoriasis. J Med Econ. 2017; 20(12): 1224–1230.
- 18Igarashi A, Igarashi A, Graham CN, Gilloteau I, Tani Y. Evaluating the cost-effectiveness of secukinumab in moderate-to-severe psoriasis: a Japanese perspective. J Med Econ. 2018; 22(1): 7–15.
- 19Augustin M, McBride D, Gilloteau I, O'Neill C, Neidhardt K, Graham CN. Cost-effectiveness of secukinumab as first biologic treatment, compared with other biologics, for moderate to severe psoriasis in Germany. J Eur Acad Dermatol Venereol. 2018; 32(12): 2191–2199.