Long-term effectiveness and safety of treatment with dupilumab in patients with atopic dermatitis: Results of the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry - 10/10/20
, Linde E.M. de Wijs, MD b, Michel H. Hof, PhD c, Beau R. van Nieuwenhuizen, MD a, Louise A.A. Gerbens, MD, PhD a, Maritza A. Middelkamp-Hup, MD, PhD a, DirkJan Hijnen, MD, PhD b, Phyllis I. Spuls, MD, PhD aAbstract |
Background |
Evidence on long-term dupilumab treatment for atopic dermatitis in daily practice is lacking.
Objective |
To investigate patient characteristics, treatment aspects, effectiveness, and safety of up to 84 weeks of dupilumab treatment.
Methods |
An observational prospective cohort study was conducted of patients with atopic dermatitis starting dupilumab in routine clinical care.
Results |
Of the 221 included patients, 103 used systemic therapy at baseline. At 84 weeks, we found a change of −15.2 (SE, 1.7) for the Eczema Area and Severity Index, −16.9 (SE, 1.4) for the Patient-Oriented Eczema Measure, and −17.2 (SE, 1.6) for the Dermatology Life Quality Index. We found a trend for improvement over time for the Investigator Global Assessment and Numerical Rating Scale for pruritus. Severe (n = 79) including serious (n = 11) adverse events were observed in 69 patients. Eye complaints were most frequently reported (n = 46). Twenty-one patients adjusted the regular dosing schedule, and 14 patients discontinued treatment, mainly due to ineffectiveness (n = 7).
Limitations |
Only adverse events of severe and serious nature were registered for feasibility reasons.
Conclusion |
Daily practice dupilumab treatment of up to 84 weeks is generally well-tolerated, apart from the reporting of eye complaints. It can be considered a long-term effective treatment for atopic dermatitis in combination with topical and initial concomitant systemic treatment, showing a sustained improvement of signs, symptoms, and quality of life.
Le texte complet de cet article est disponible en PDF.Key words : atopic dermatitis, atopic eczema, daily practice, dupilumab, effectiveness, registry, routine clinical care, safety, systemic immunomodulating treatment
Abbreviations used : AD, AE, DLQI, EASI, EMC, IGA, NRS, POEM, TREAT NL, UMC
Plan
| Funding sources: This study was partly funded by a government grant through ZonMw (The Netherlands Organization for Health Research and Development), program Rational Pharmacotherapy. |
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| Conflicts of interest: Dr Middelkamp-Hup is a consultant for Sanofi and Pfizer. Dr Hijnen is an investigator for LEO Pharma, MedImmune/AstraZeneca, Novartis, and Sanofi/Regeneron and is a consultant for Regeneron/Sanofi, LEO Pharma, MedImmune/AstraZeneca, Novartis, Incyte, Janssen, and Pfizer. Dr Spuls has been a consultant in the past for Sanofi 111017 and AbbVie 041217 (unpaid), received independent research grants >5 years ago, and is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of psoriasis and atopic dermatitis for which financial compensation is paid to the hospital. Drs Bosma, de Wijs, van Nieuwenhuizen, and Gerbens have no conflicts of interest to declare. |
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| IRB approval status: Our study was exempted from evaluation by the local Medical Research Ethics Committees (MEC-2017-1123; W18_097#18.123). |
Vol 83 - N° 5
P. 1375-1384 - novembre 2020 Retour au numéro
Article précédent
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