Ocular adverse events in patients with atopic dermatitis undergoing treatment with dupilumab: An Italian single‐center experience

Napolitano, Maddalena; Guida, Adriana Di; Fabbrocini, Gabriella; Patruno, Cataldo

doi:10.1111/dth.15059

Cited by 7 publications

(8 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Of note, no cases of conjunctivitis were reported in patients who received spesolimab, in contrast to what has been observed in previous clinical trials with other therapies in moderate-to-severe AD. 29,30 These safety findings are in line with previous studies of spesolimab in healthy volunteers and in patients with GPP or PPP. [17][18][19]26 The primary endpoint, percentage change from baseline in EASI at Week 16, between placebo and spesolimab groups (25.6%; p 0.149) was not statistically significant.…”

Section: Discussionsupporting

confidence: 89%

“…In this study, spesolimab was well tolerated, and its safety profile was comparable to that of placebo, with no new or unexpected safety signals observed. Of note, no cases of conjunctivitis were reported in patients who received spesolimab, in contrast to what has been observed in previous clinical trials with other therapies in moderate‐to‐severe AD 29,30 . These safety findings are in line with previous studies of spesolimab in healthy volunteers and in patients with GPP or PPP 17–19,26 …”

Section: Discussionsupporting

confidence: 87%

See 1 more Smart Citation

Spesolimab, an anti‐interleukin‐36 receptor antibody, in patients with moderate‐to‐severe atopic dermatitis: Results from a multicentre, randomized, double‐blind, placebo‐controlled, phase IIa study

Bissonnette

Abramovits

Proulx

et al. 2023

Acad Dermatol Venereol

View full text Add to dashboard Cite

Background Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease, and there is increasing evidence that the interleukin (IL)‐36 pathway may play a role in the pathogenesis of AD. Objectives To evaluate the efficacy and safety of spesolimab, a novel anti‐IL‐36 receptor antibody, in adult patients with moderate‐to‐severe AD. Methods In this phase IIa study, 51 eligible patients were randomized 2:1 to receive intravenous doses of spesolimab 600 mg or placebo every 4 weeks. The primary endpoint was the percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 16. Results The decrease in EASI score from baseline to Week 16 was –37.9% for spesolimab versus –12.3% for placebo (adjusted mean difference −25.6%, p = 0.149). A predefined sensitivity analysis, excluding data from patients who used restricted corticosteroids, resulted in an adjusted mean difference of −48.3% (nominal p = 0.024). Spesolimab was well tolerated, with no clinically relevant safety signals. Conclusions This is the first study to evaluate the IL‐36 pathway inhibition in AD. Although not statistically significant, numerical improvements were observed in the primary endpoint of change from baseline in the EASI score. Spesolimab had an acceptable safety profile, with no unexcepted safety concerns.

show abstract

Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 87%

Spesolimab, an anti‐interleukin‐36 receptor antibody, in patients with moderate‐to‐severe atopic dermatitis: Results from a multicentre, randomized, double‐blind, placebo‐controlled, phase IIa study

Bissonnette

Abramovits

Proulx

et al. 2023

Acad Dermatol Venereol

View full text Add to dashboard Cite

show abstract

“…Across the clinical development programme 1% (2/217) of patients discontinued dupilumab therapy due to DAOSD, 3 and a further 1.4% (3/217) patients who had experienced DAOSD withdrew from dupilumab therapy because of conjunctivitis‐related adverse events in the 3‐year open‐label extension study 5 . Similar outcomes have been observed in the BioDay registry data, with 2.4% (5/210) of patients discontinuing therapy due to conjunctivitis, 48 and in recent larger real‐world observational case series the majority of patients who experienced DAOSD remained on dupilumab therapy [range 84–100%] 12,39,49 . It is now accepted that, where possible, discontinuation of dupilumab should be avoided 15,23,55–58 .…”

Section: Resultssupporting

confidence: 62%

“… 5 Similar outcomes have been observed in the BioDay registry data, with 2.4% (5/210) of patients discontinuing therapy due to conjunctivitis, 48 and in recent larger real‐world observational case series the majority of patients who experienced DAOSD remained on dupilumab therapy [range 84–100%]. 12 , 39 , 49 It is now accepted that, where possible, discontinuation of dupilumab should be avoided. 15 , 23 , 55 , 56 , 57 , 58 Several authors support a multidisciplinary management approach.…”

Section: Resultssupporting

confidence: 58%

Dupilumab‐associated ocular surface disease: An interdisciplinary decision framework for prescribers in the Australian setting

et al. 2022

View full text Add to dashboard Cite

Background/Objectives Dupilumab‐associated ocular surface disease (DAOSD) is of particular relevance in patients with atopic dermatitis (AD). Guidance on DAOSD assessment and management in the Australian setting is needed to reduce its impact and minimise disruption to treatment. Methods A systematic review of the literature was undertaken to identify data pertaining to the incidence, pathophysiology, risk factors and management of DAOSD. A critical review of this literature was used to inform a decision framework for dupilumab‐prescribers and develop a graded severity scoring tool to guide appropriate management options. Results DAOSD typically emerges within 4 months of commencing dupilumab and the occurrence of new events diminishes over time. The reported incidence varies widely depending on the nature and source of the data: 8.6–22.1% (clinical trials programme), 0.5–70% (real‐world data; differences in study size, duration of follow‐up, ophthalmologist intervention, use of prophylaxis). Occurrence increases with AD severity and in patients with prior history of ocular disease; pathophysiology is still to be fully characterised. Management options have evolved over time and include lubricants/artificial tears, corticosteroids, calcineurin inhibitors, antihistamines, anti‐inflammatory agents and antimicrobial agents. Current therapies aim to resolve symptoms or reduce severity to levels sufficiently tolerable to enable continuation of dupilumab therapy. Conclusions Recommendations for DAOSD assessment and management include identification of high‐risk patients, vigilance for red flags (keratoconus, herpetic and bacterial keratitis), regular assessment of symptom severity (before and during dupilumab therapy), conservative management of mild DAOSD by the prescribing physician and ophthalmologist referral for collaborative care of moderate–severe DAOSD and high‐risk patients.

show abstract

“…Previous literature reported that prolonged dose interval was effective and safe in patients with stable disease, also leading to both improvement of patient's adherence and reduction of costs 5 . On the other hand, it has been reported that interval prolongation improved dupilumab‐associated conjunctivitis 6,7 …”

Section: Introductionmentioning

confidence: 99%

Dupilumab dose spacing after initial successful treatment or adverse events in adult patients with atopic dermatitis: A retrospective analysis

Patruno

Potestio

Fabbrocini

et al. 2022

Dermatologic Therapy

Self Cite

View full text Add to dashboard Cite

Strategies on long‐term management of patients affected by atopic dermatitis (AD) undergoing treatment with dupilumab achieving good clinical response (GCR) or experiencing dupilumab‐related adverse events (AEs) are scant. Data of patients who implemented longer than scheduled dupilumab dosing interval due to GCR (at least 52 weeks of treatment and controlled AD activity [Eczema Area Severity Index ≤7 and Dermatology Life Quality Index ≤5 for at least 6 months]) or AEs (dupilumab‐related and treatment‐resistant conjunctivitis) were retrospectively collected. Dupilumab was tapered to Q3W or Q4W based on physician‐patient shared decision. At baseline (T0) and each follow‐up (week 16 [T1] and week 32 [T2]) disease severity was assessed. A total of 59 patients implemented longer than scheduled dosing interval (44 GCR, 15 AEs). Among these, 50 (35 GCR and 15 conjunctivitis) patients switched to 300 mg Q3W, while nine GCR subjects to Q4W. In the GCR group Q3W, 34 and 31 patients maintained clinical response at T1 and T2, whereas eight and seven Q4W subjects maintained clinical response at the same timepoints, respectively. No significant differences in AD severity were observed between T1 and T2 in both groups. Contrariwise, one Q3W and one Q4W patients at T1, and three Q3W and one Q4W subjects at T2, returned to dupilumab labeled dosage due to AD worsening. In conjunctivitis group, dupilumab Q3W was maintained in eight and four patients at T1 and T2, respectively. Three patients at T1 and three at T2 subjects returned to the labeled interval due to conjunctivitis remission. Four patients at T1 and four subjects at T2 interrupted dupilumab due to the persistence of conjunctivitis. A longer dupilumab dosing interval may be a valuable option in patients with a GCR and may be a useful strategy to reduce treatment‐related conjunctivitis, also with pharmacoeconomic benefit.

show abstract

Ocular adverse events in patients with atopic dermatitis undergoing treatment with dupilumab: An Italian single‐center experience

Cited by 7 publications

References 15 publications

Spesolimab, an anti‐interleukin‐36 receptor antibody, in patients with moderate‐to‐severe atopic dermatitis: Results from a multicentre, randomized, double‐blind, placebo‐controlled, phase IIa study

Spesolimab, an anti‐interleukin‐36 receptor antibody, in patients with moderate‐to‐severe atopic dermatitis: Results from a multicentre, randomized, double‐blind, placebo‐controlled, phase IIa study

Dupilumab‐associated ocular surface disease: An interdisciplinary decision framework for prescribers in the Australian setting

Dupilumab dose spacing after initial successful treatment or adverse events in adult patients with atopic dermatitis: A retrospective analysis

Contact Info

Product

Resources

About