Prescriptions hors AMM (autorisation de mise sur le marché) dans le psoriasis de l’enfant

Mahé, E.; Corgibet, Florence; Maccari, F.; Hadj‐Rabia, S.; Phan, C.; Ruer‐Mulard, M.; Boralévi, F.; Barbarot, S.; Bursztejn, A.‐C.; Lahfa, M.; Sévérino-Freire, Maëlla; Aubin, F.; H, Barthélémy; Bretèque, M. Amy de la; Beauchet, Alain; Pédiatrique, Groupe de Recherche de Recherche de la Société Française de Dermatologie de; dermatologie-vénéréologie, la Fédération française de formation continue et d’évaluation en; Resopso, et le Gem

doi:10.1016/j.annder.2020.01.021

Cited by 6 publications

(3 citation statements)

References 43 publications

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“…In a recent study, Mahe et al ( 11 ) found that 34.9% of paediatric patients with psoriasis evaluated in public hospitals received off-label prescriptions, where topical vitamin D was the main off-label treatment. Although this disease was scarcely represented in our study population ( n = 4), all the patients with psoriasis received topical off-label treatments (tacrolimus, calcipotriol and calcipotriol combined with betamethasone).…”

Section: Discussionmentioning

confidence: 99%

Off-label Prescription in Paediatric Dermatology: A Retrospective Observational Study in a Tertiary Hospital

Couselo-Rodríguez,

Batalla,

Martínez-Fernández

et al. 2023

Acta Derm Venereol

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Off-label prescription in paediatric patients is common, where some studies indicate that dermatological conditions are more prone to off-label treatment. This is the first study to analyse the prevalence of off-label prescription in paediatric dermatology consultation. This retrospective observational study was performed using the medical records of paediatric patients who were evaluated in a paediatric dermatological consultation in Pontevedra University Hospital, Pontevedra, Spain. Of the 468 patients reviewed, 186 prescriptions were issued and 51.10% were off-label prescription drugs. The dermatological conditions for which off-label prescription was most common were atopic dermatitis (29.0%), followed by warts (12.9%) and infantile haemangiomas (11.8%). With respect to drugs, topical tacrolimus (23.7%) was the most frequently prescribed off-label drug. The main reason for prescribing an off-label drug was for a disease not included on the label (62.4%), followed by issuing it at a lower age than authorized (55.9%). There was a significant association between a higher percentage of off-label prescription and younger age (p < 0.001), and the treatment of vitiligo, infantile haemangiomas and warts (p < 0.001). Likewise, the off-label prescription was significantly more common in the case of topical terbinafine, timolol, desloratadine and topical salicylic acid (p < 0.001). To conclude, off-label prescription is predominant in paediatric dermatology, as observed in 51.1% of our patients.

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Section: Discussionmentioning

confidence: 99%

Off-label Prescription in Paediatric Dermatology: A Retrospective Observational Study in a Tertiary Hospital

Couselo-Rodríguez,

Batalla,

Martínez-Fernández

et al. 2023

Acta Derm Venereol

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“…However, in a recent study, we found that up to 100% of adolescents with severe psoriasis had received unlicensed treatments. 49 There are now enough data from registers, cohorts and clinical trials to assess the real-world benefits and tolerance of adult treatments in adolescents. [50][51][52][53][54][55] In France, treatments can be prescribed for "off-label" use under the following circumstances: 1) there is no alternative licensed drug; 2) the treatment is recognized as effective and safe by the scientific community and literature; 3) the indication is "essential" with regard to the patient's condition, is necessary for the patient, and is consistent with current scientific knowledge; 4) the prescriber has informed the patient of the absence of official authorization for the prescription, the absence of therapeutic alternatives, the expected benefits, and the risks or constraints of the drug, as well as the conditions of health insurance coverage; and 5) justification for the prescription is recorded in the patient's medical file.…”

Section: General Managementmentioning

confidence: 99%

“…Topical steroids are the reference treatment for psoriasis, most commonly prescribed as a combination of calcipotriol (50 μg/g) and betamethasone dipropionate (0.5 mg/g). 49,51 These treatments are recommended for skin-limited disease. The potency of the steroids prescribed must be adapted according to disease severity and location.…”

Section: Topical Treatmentsmentioning

confidence: 99%

<p>Optimal Management of Plaque Psoriasis in Adolescents: Current Perspectives</p>

Mahé

2020

PTT

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The skin is at the interface between the body and its environment and is therefore at the center of adolescent concerns during this period of identity formation and increased awareness of body image issues, and stigmatization. Managing an adolescent with psoriasis involves managing the illness and the individual during their transition from being an older child to a young adult. In addition to ensuring that the patient adheres to treatments and is engaged with the therapeutic strategy, dermatologists may also need to manage issues linked to unspoken suffering or conflicts between the adolescent and their parents, who are often present during consultations. The impact of psoriasis on the social interactions, school life and sexuality of the patients, together with the influence of the internet and social networks, also have to be taken into account. In this review, we summarize the epidemiologic, clinical, and therapeutic data available on psoriasis in adolescents, and propose specific management strategies, adapted to the 21st century, for patients in this age group.

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Patient Characteristics and Treatment Patterns in European Pediatric Patients with Psoriasis: A Real-World, Cross-Sectional Study

Sticherling¹,

McPherson

Laguna

et al. 2022

Dermatol Ther (Heidelb)

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Introduction: This study evaluated patient characteristics and treatment patterns according to weight in pediatric patients with psoriasis in a real-world setting. Methods: Primary care and specialist physicians treating pediatric patients with psoriasis aged 6-17 years in five European countries were surveyed in the 2019-2020 Adelphi Real World Pediatric Psoriasis Disease Specific Programme. At least two patients with current or previous biologic use were included per physician. Patient characteristics and treatment patterns were analyzed overall and for patients weighing 25-50 kg or more than 50 kg. Results: Data from 772 patients weighing 25-50 kg and 1147 weighing more than 50 kg were analyzed. Median age at diagnosis was significantly less in lighter than heavier patients (10.0 vs. 14.0 years; p \ 0.001), as was median disease duration (2.2 vs. 3.0 years; p \ 0.001). Topical treatments were prescribed in 59.0% of patients overall (70.3% of lighter and 51.4% of heavier patients; p \ 0.001), and were used to

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Prescriptions hors AMM (autorisation de mise sur le marché) dans le psoriasis de l’enfant

Cited by 6 publications

References 43 publications

Off-label Prescription in Paediatric Dermatology: A Retrospective Observational Study in a Tertiary Hospital

Off-label Prescription in Paediatric Dermatology: A Retrospective Observational Study in a Tertiary Hospital

<p>Optimal Management of Plaque Psoriasis in Adolescents: Current Perspectives</p>

Patient Characteristics and Treatment Patterns in European Pediatric Patients with Psoriasis: A Real-World, Cross-Sectional Study

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