action was tested using a logistic model with treatment, nail involvement, and treatment-by-nail involvement interactions included in the model. Within each severity of nail involvement category, comparisons between treatment groups were made using the Cochran-Mantel-Haenszel (CMH) test stratified by study. Within each treatment group, comparisons between severities of nail involvement were also made using the CMH test. Missing data were imputed using non-responder imputation. In addition, Kaplan-Meier product limit method was used to estimate the time to first efficacy response, with treatment comparison done using a log-rank test stratified by study.
RESULTS
Of the 2570 patients with moderate-to-severe plaque psoriasis in the integrated dataset, 61.1% had fingernail involvement (NAPSI >0; n=1569), and 38.6% had severe nail psoriasis (NAPSI ≥16; n= 993) at baseline. Overall mean (SD) total scores at baseline were NAPSI 26.3 (20.1) (only those with nail involvement), PASI 20.3 (7.8), and sPGA 3.5 (0.6). Baseline characteristics were balanced across treatments (Table 1).
Significantly more patients treated with IXEQ2W and IXEQ4W achieved all endpoints starting as early as week 4 than those treated with ETN or PBO (P<0.05), regardless of nail psoriasis presence (Figure 1) or severity (Supplemental Figure 1). In the IXEQ2W treatment group, significantly more patients with nail psoriasis (NAPSI >0) than those without (NAPSI=0) achieved PASI 75 at week 8 (83.9% vs. 76.3%, P=0.01) and week 12 (91.1% vs 84.7%; P=0.008). Likewise, in the IXEQ2W treatment group, significantly more patients with severe nail psoriasis (NAPSI ≥16) compared with mild nail psoriasis (NAPSI <16) also achieved PASI 75 at week 8 (85.1% vs 78.4%; P=0.025) and week 12 (91.8% vs 86.5%; P=0.031). A similar percentage of patients in the IXEQ2W treatment group achieved PASI 90, PASI 100, sPGA (0,1), and sPGA (0) at all time points, regardless of nail psoriasis presence or severity.
In the IXEQ4W treatment group at week 12 (not an approved dose regimen in the US for moderate-to-severe psoriasis)15 significantly more patients with nail psoriasis than without achieved sPGA (0,1) (76.9% vs. 70.1%; P=0.039), and a similar percentage of patients with severe and mild nail psoriasis achieved all endpoints. In the IXEQ4W treatment group, there were fluctuations in the response rates in patients without nail psoriasis who achieved PASI 100 and sPGA (0) that reached significance at week 4 (PASI 100 and sPGA [0]) and week 8 (PASI 100). However, by week 12 in both of these cases, there were numerically better responses in the patients with nail psoriasis.
In the ETN group, significantly more patients with severe nail psoriasis than with mild nail psoriasis achieved sPGA (0,1) at week 2 (3.6% vs 1.2%; P=0.017) (Supplemental Figure 1).
In both the IXEQ2W and IXEQ4W treatment groups, the Kaplan- Meier estimates for time to first response for PASI 75, PASI 90, PASI 100, sPGA (0,1), and sPGA (0) were all significantly earlier than either the PBO or ETN groups (P<0.001), regardless of nail psoriasis presence (Figure 2) or severity (Supplemental Figure 2). In both the IXEQ2W and IXEQ4W treatment groups, the Kaplan-Meier estimates for time to first response for PASI
Significantly more patients treated with IXEQ2W and IXEQ4W achieved all endpoints starting as early as week 4 than those treated with ETN or PBO (P<0.05), regardless of nail psoriasis presence (Figure 1) or severity (Supplemental Figure 1). In the IXEQ2W treatment group, significantly more patients with nail psoriasis (NAPSI >0) than those without (NAPSI=0) achieved PASI 75 at week 8 (83.9% vs. 76.3%, P=0.01) and week 12 (91.1% vs 84.7%; P=0.008). Likewise, in the IXEQ2W treatment group, significantly more patients with severe nail psoriasis (NAPSI ≥16) compared with mild nail psoriasis (NAPSI <16) also achieved PASI 75 at week 8 (85.1% vs 78.4%; P=0.025) and week 12 (91.8% vs 86.5%; P=0.031). A similar percentage of patients in the IXEQ2W treatment group achieved PASI 90, PASI 100, sPGA (0,1), and sPGA (0) at all time points, regardless of nail psoriasis presence or severity.
In the IXEQ4W treatment group at week 12 (not an approved dose regimen in the US for moderate-to-severe psoriasis)15 significantly more patients with nail psoriasis than without achieved sPGA (0,1) (76.9% vs. 70.1%; P=0.039), and a similar percentage of patients with severe and mild nail psoriasis achieved all endpoints. In the IXEQ4W treatment group, there were fluctuations in the response rates in patients without nail psoriasis who achieved PASI 100 and sPGA (0) that reached significance at week 4 (PASI 100 and sPGA [0]) and week 8 (PASI 100). However, by week 12 in both of these cases, there were numerically better responses in the patients with nail psoriasis.
In the ETN group, significantly more patients with severe nail psoriasis than with mild nail psoriasis achieved sPGA (0,1) at week 2 (3.6% vs 1.2%; P=0.017) (Supplemental Figure 1).
In both the IXEQ2W and IXEQ4W treatment groups, the Kaplan- Meier estimates for time to first response for PASI 75, PASI 90, PASI 100, sPGA (0,1), and sPGA (0) were all significantly earlier than either the PBO or ETN groups (P<0.001), regardless of nail psoriasis presence (Figure 2) or severity (Supplemental Figure 2). In both the IXEQ2W and IXEQ4W treatment groups, the Kaplan-Meier estimates for time to first response for PASI
