No increased risk of infection with long-term dupilumab for atopic dermatitis

Data from the ongoing, open-label, extension study LIBERTY AD OLE indicated no elevation in number of cases of overall and serious infections emerging from dupilumab therapy for atopic dermatitis over 3 years.

Atopic dermatitis (AD) is a chronic inflammatory skin disease that includes alterations of the skin barrier and carries an increased risk for cutaneous infections of both bacterial and viral origin that may lead to systemic infections [1]. Dupilumab –an IL-4/IL-13 blocker not categorised as immunosuppressant– previously demonstrated in clinical trials to be linked to a reduced risk for severe infections and no elevation on overall rates for infection [2]. To learn more about the occurrence of infections in long-term treatment with dupilumab in patients with moderate-to-severe AD, the new evaluation presented by Prof. Andrew Blauvelt (Oregon Medical Research Center, USA) described incidence rates over 3 years by number of patients (nP) per 100 patient-years (PY) within the ongoing, open-label, extension study LIBERTY AD OLE (NCT01949311) [3].

All study subjects in this trial took part in phase 3 trials with dupilumab. They were treated with 300 mg of dupilumab once per week. As there is no control arm in OLE, the current analysis compared the infection rates from OLE to data from CHRONOS (NCT02260986), the largest study to date to investigate placebo versus 300 mg dupilumab weekly with concomitant topical corticosteroids (TCS) in both arms over 52 weeks. The current analysis included 2,677 patients receiving 300 mg dupilumab in the OLE. The 2 study arms of CHRONOS had 315 patients each, receiving either dupilumab with TCS or placebo plus TCS.

In general, infection rates were lower in OLE than in CHRONOS. Treatment-emergent overall infections were present in 74.07 nP/100 PY in OLE versus dupilumab plus TCS with 93.66 nP/100 PY and placebo plus TCS with 106.98 nP/100 PY in CHRONOS, respectively. Infections leading to a termination of treatment were found in 0.35 nP/100PY in OLE, 0.92 nP/100 PY (placebo + TCS), and 0.00 nP/100 PY (dupilumab + TCS). As for treatment-emergent severe or serious infections, the corresponding rates were 1.43 nP/100 PY in OLE compared with 2.12 nP/100 PY in the placebo arm and 0.34 in the dupilumab group of CHRONOS (see Figure). The most frequent infections were nasopharyngitis, upper respiratory tract infections, and conjunctivitis. The authors concluded that dupilumab is a suitable long-term treatment for moderate-to-severe AD, as no augmented risk of skin or systemic infections was found.

Figure: Infection rates in LIBERTY AD OLE (dupilumab monotherapy) and CHRONOS (dupilumab + topical steroids and placebo + topical steroids) [3]

1. Ong PY, Leung DY. Clin Rev Allergy Immunol. 2016;51(3):329-337.
2. Eichenfield LF, et al. Am J Clin Dermatol. 2019;20(3):443-456.
3. Blauvelt A, et al. Infections in adults with moderate-to-severe atopic dermatitis treated with dupilumab: long-term data from an open-label extension (OLE) study. Poster 27424, AAD VMX 2021, 23-25 April.

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Posted on 7 June 202129 February 2024