Table 4.

Proportion of patients with at least one adverse event of conjunctivitis during the treatment period in atopic dermatitis trials, and hazard ratios (HRs) with 95% confidence intervals (CIs) for dupilumab vs. placebo: SOLO‐CONTINUE

MedDRA preferred term	Patients with ≥ 1 event: n (%) and HR vs. placebo (95% CI)
	Placebo (n = 82)	Dupilumab 300 mg q8w (n = 84)	Dupilumab 300 mg q4w (n = 87)	Dupilumab 300 mg qw or q2w (n = 167)	Dupilumab combined (n = 338)
Total	4 (4.9)	3 (3.6)	4 (4.6)	9 (5·4)	16 (4·7)
		0·75 (0·17–3·36)	1·00 (0·25–3·99)	1·13 (0·35–3·68)	1·00 (0·33–2·98)
Conjunctivitis	2 (2.4)	2 (2.4)	2 (2.3)	6 (3·6)	10 (3·0)
		1·00 (0·14–7·10)	0·99 (0·14–7·00)	1·51 (0·30–7·46)	1·24 (0·27–5·65)
Allergic conjunctivitis	1 (1.2)	1 (1.2)	2 (2.3)	2 (1·2)	5 (1·5)
		1·05 (0·07–16·85)	2·05 (0·19–22·7)	1·02 (0·09–11·2)	1·26 (0·15–10·8)
Bacterial conjunctivitis	1 (1.2)	0	0	1 (0·6)	1 (0·3)
		0 (0–NC)	0 (0–NC)	0·48 (0·03–7·64)	0·24 (0·02–3·90)

The HR and its 95% CI are from a Cox regression model, which includes treatment groups as fixed effects, stratified by baseline disease severity (Investigator's Global Assessment = 3 vs. 4). MedDRA, Medical Dictionary for Regulatory Activities; q8w, every 8 weeks; q4w, every 4 weeks; q2w, every 2 weeks; qw, every week; NC, not calculable.