25 research outputs found
Conjunctivitis in dupilumab clinical trials
Background Dupilumab blocks the shared receptor component for interleukin (IL)-4
and IL-13. It is approved in the U.S.A. for patients aged ≥ 12 years with moderate-tosevere atopic dermatitis (AD) uncontrolled by topical prescription medicines or who
cannot use topical medicines, for patients in Japan whose AD is uncontrolled with
existing therapies, for patients with moderate-to-severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment
of moderate-to-severe asthma uncontrolled with their current medicines. AD trials
have reported increased incidence of conjunctivitis for dupilumab vs. placebo.
Objectives To characterize further the occurrence and risk factors of conjunctivitis
in dupilumab clinical trials.
Methods We evaluated randomized placebo-controlled trials of dupilumab in AD
(n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps
(CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47).
Results In most AD trials, dupilumab-treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous history of conjunctivitis were associated with increased conjunctivitis incidence. Conjunctivitis was
mostly mild to moderate. Most cases recovered or resolved during the treatment period; two patients permanently discontinued dupilumab due to conjunctivitis or keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and
antihistamines or mast cell stabilizers. Most cases were diagnosed by the investigators.
In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both
dupilumab and placebo than in AD trials; dupilumab did not increase the incidence
compared with placebo. In the EoE trial, no patients had conjunctivitis.
Conclusions Conjunctivitis was more frequent with dupilumab treatment in most
AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the
incidence of conjunctivitis was associated with AD severity and prior history of
conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated
patients require further study