Adverse events associated with discontinuation of the biologics/classic systemic treatments for moderate‐to‐severe plaque psoriasis: data from the Spanish Biologics Registry, Biobadaderm

Belinchón, Isabel; Ramos, J.M.; Carretero, G.; Ferrándiz, Carlos; Rivera, R.; Daudén, E.; Cueva‐Dobao, P. de la; Gómez-García, Francisco; Herrera‐Ceballos, Enrique; Sánchez‐Carazo, J.L.; López-Estebaranz, J.L.; Alsina, M.; Ferrán, Marta; Torrado, R.; Carrascosa, J.M.; Llamas‐Velasco, Mar; Ortiz, Pablo; García‐Doval, I.; Descalzo, M.Á.

doi:10.1111/jdv.14314

Cited by 21 publications

(35 citation statements)

References 26 publications

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“…This is not a surprising finding, as these two characteristics have been associated with higher drug persistence in previous studies (Belinchon, Ramos, & Carretero, 2017;Davila-Seijo, Dauden, & Carretero, 2016;Menter et al, 2016). Overall, for most patients, the most important treatment attributes were risk for SAEs and the duration of clinical response.…”

Section: Discussionsupporting

confidence: 61%

Patient preference study for different characteristics of systemic psoriasis treatments (Protimisis)

Rigopoulos

Ioannides

Chaidemenos

et al. 2018

Dermatologic Therapy

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"The Protimisis" study was a multicenter, cross-sectional study investigating the relative importance and economic value that patients assign to different characteristics of systemic psoriasis treatments. Treatment preferences were investigated with the DCE methodology and patients had to decide over the most important aspects of different psoriasis treatments. A questionnaire regarding demographic data/medical history and the DLQI and EQ-5D-3L questionnaires were also completed. A total of 310 patients were included. Out of those, 37.4% reported using oral medications for psoriasis as their most recent treatment, while the remaining patients reported treatment with injections once per week (14.8%), injections twice per week (7.4%), injections once every three months (29.4%) and intravenous injections every two months (8.4%) as their most recent treatment. Mean DLQI score was 6.6 (SD 6.5), and in the EQ-5D-3L index, 71.0% of patients reported having problems with anxiety or depression. DCE analysis showed a clear preference for treatments with longer dosing intervals, rapid onset of action, lasting clinical response, low risk of SAEs and lower cost. The risk of SAEs was the most important treatment characteristic (54% of patients). Older patients showed less concern for safety matters than younger patients. The highest willingness-to-pay was recorded for treatments with longer dosing intervals and for safer treatment options.

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Section: Discussionsupporting

confidence: 61%

Patient preference study for different characteristics of systemic psoriasis treatments (Protimisis)

Rigopoulos

Ioannides

Chaidemenos

et al. 2018

Dermatologic Therapy

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“…For adalimumab, etanercept, infliximab and ustekinumab, adverse events were comparable with previously published observational studies for biological registers (Table 3). 21 The highest rate of infections occurred with secukinumab (incidence rate 19Á1 per 100 person-years). Four cases of cardiovascular events were reported during treatment with Data are mean AE SD or n (%).…”

Section: Safety Of Biologics and Biosimilarsmentioning

confidence: 99%

Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

et al. 2018

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Ustekinumab was associated with the highest drug survival, and secukinumab with the lowest, although most patients on secukinumab were non-naïve. Switching from originator to biosimilar had no significant impact on drug survival, and the safety profiles were comparable. Adverse events occurred most frequently with secukinumab. Future studies are warranted to assess the long-term safety of novel biologics for psoriasis.

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“…22,23 In the ESPRIT registry, 388 events (2.0/100 PY) led to study drug discontinuation. 22,23 In the ESPRIT registry, 388 events (2.0/100 PY) led to study drug discontinuation.…”

Section: Discontinuations Due To Aesmentioning

confidence: 99%

“…22,23 In the ESPRIT registry, 388 events (2.0/100 PY) led to study drug discontinuation. 23 The most common AEs leading to discontinuation were infections and infestations (n = 32), musculoskeletal and connective tissue disorders (n = 14), and skin and subcutaneous tissue disorders (n = 13). 20 Inzinger et al 22 reported 17 AEs (3.7%) that led to discontinuation among 460 adalimumab treatment cycles in the Psoriasis Registry Austria; the most common AEs were injection site reaction (four events), systemic reaction/anaphylaxis (three events) and infection (two events).…”

Section: Discontinuations Due To Aesmentioning

confidence: 99%

Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries

Strober

Crowley

Langley

et al. 2018

Acad Dermatol Venereol

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Long-term safety of adalimumab in psoriasis clinical studies has been established. The objective of this research was to review real-world evidence of adalimumab safety from registries of adult patients with psoriasis treated in clinical practice. Databases (BIOSIS Previews, Current Contents Search, Derwent Drug File, EMBASE, EMBASE Alert, EMCare, MEDLINE, SciSearch) were searched for psoriasis registries with adalimumab safety data. Eligible papers were English language manuscripts (conference abstracts excluded) from psoriasis registries presenting safety data for adult patients with psoriasis receiving adalimumab. The incidence and rate (events/100 patient-years [PY]) of adverse events (AEs), serious AEs (SAEs) and AEs of special interest are reported. Abstracts of 425 publications were screened, and 401 publications excluded (208 conference abstracts; 193 papers). Remaining manuscripts were fully screened; 14 were excluded (no adalimumab data, n = 10; no safety data, n = 2; no on-treatment data, n = 1; not English, n = 1), and 10 selected. Overall rates of AEs (4273 [22.2/100PY]) and SAEs (827 [4.3/100PY]) were reported in the ESPRIT registry (N = 6059). Rates of infections (7.7-14.7/100PY) and serious infections (<0.6-2.0/100PY) were reported in four studies. Cardiovascular-related events were reported in three studies: ≤0.1/100PY per major cardiac event in ESPRIT, <0.5/100PY major cardiac events in PsoBest and serious cardiovascular events in two patients (<1%) in DERMBIO. Malignancies were reported in three studies (any malignancy, 0.9/100PY; malignancies excluding non-melanoma skin cancer [NMSC], <0.6/100PY; NMSC, 0.6-<0.5/100PY). These findings suggest that real-world safety of adalimumab is consistent across different psoriasis registries, which supports the existing long-term safety profile of adalimumab from clinical studies.

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Adverse events associated with discontinuation of the biologics/classic systemic treatments for moderate‐to‐severe plaque psoriasis: data from the Spanish Biologics Registry, Biobadaderm

Abstract: Biologic therapies are associated with a lower rate of discontinuation-related AEs than are classic therapies in real clinical practice. Ustekinumab showed the lowest incidence.

Cited by 21 publications

References 26 publications

Patient preference study for different characteristics of systemic psoriasis treatments (Protimisis)

Patient preference study for different characteristics of systemic psoriasis treatments (Protimisis)

Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries

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