Guselkumab for treatment of moderate-to-severe plaque psoriasis: real-life effectiveness and drug-survival for up to 148 weeks

Figures & data

Table 1. Demographic and clinical characteristics of the cohort (122 patients).

		Range
Age (years; mean ± SD)	51.5 ± 14.6	21–79
Sex (N, %)
Male	64 (52.6)	-
Female	58 (47.4)	-
Duration of disease	24.0 ± 15.9	1–67
Age at onset (years; mean ± SD)	27.5 ± 15.6	0–67
Onset at ≤12 years (N)	19
Onset at 13 ≤ years≤17 (N)	17
Onset at ≥18 years (N)	86
PASI at baseline (mean ± SD)	16.2 ± 12.9	3.0–60.0
Prior biologic therapy	79 (64.8%)
One prior treatment (N)	38
Two prior treatments (N)	24
Three prior treatments (N)	10
≥4 prior treatments (N)	7
Last biologic before switching to guselkumab
anti-TNFa	8 (11.1)
anti-IL17	34 (43.0)
anti-IL-12/IL-23	35 (44.3)
anti-IL23p19	2 (2.5)
BMI (mean, kg/m^2)	28.6 ± 6.1	19.1 ± 52.7
Smoking (N, %)	52 (42.6)	-
Comorbidities (N, %)
Hypertension	38 (31.1)	-
Dyslipidemia	21 (17.2)	-
Diabetes	12 (9.8)	-
Obesity	40 (32.8)	-
BMI 30–34.9	25 (20.5)	-
BMI 35–39.9	9 (7.4)	-
BMI≥40	6 (4.9)	-
Psychiatric comorbidity	12 (9.8)	-
Hepatic steatosis	5 (4.1)	-
Thyroiditis	6 (4.9)	-
Infections	11 (9.0)	-
HIV+ (N)	1
HBV+ (N)	4
HCV+ (N)	1
TB GOLD+ (N)	5
Psoriatic arthritis	14 (11.5)	-

Figure 1. Effect of guselkumab on Psoriasis Area and Severity Index (PASI) score and achievement of PASI 75, 90, and 100 responses over 148 weeks in patients with moderate-to-severe psoriasis. Missing values for intermediate visits were imputed with the last observation carried forward (LOCF) method. a: mean PASI scores in the overall population. B: improvement in PASI 75, 90, and 100 responses in the cohort of all patients. C: mean PASI scores in obese (BMI≥30) and non-obese (BMI<30) patients. Improvement in PASI 75 (D), 90 (E), and 100 (F) responses in obese and non-obese patients.

Figure 2. Effect of guselkumab on PASI 75, 90, and 100 responses over 148 weeks in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis (panels a, b and c), in bio-experienced patients with moderate-to-severe psoriasis who had received<3 or ≥ 3 previous lines of biologic therapy (PBT) (panels d, e and f), and in patients with moderate-to-severe psoriasis who switched from ustekinumab over 100 weeks (panel g). Missing values for intermediate visits were imputed with the last observation carried forward (LOCF) method.

Table 2. Univariate logistic regression analysis of variables associated with PASI 75 response.

Variable	OR (95% CI)	P-value
4 weeks
Number of comorbidities	0.63 (0.43–0.92)	0.018
12 weeks
Naïve/PBT	2.44 (1.02–5.88)	0.045

Note: CI = confidence interval, OR = odds ratio, PASI = psoriasis area severity index, PBT = previous biologic treatment.

Table 3. Univariate logistic regression analysis of variables associated with PASI 90 response.

Variable	OR (95% CI)	P-value
4 weeks
Number of comorbidities	0.57 (0.35–0.93)	0.024
12 weeks
Number of comorbidities	0.71 (0.51–0.99)	0.048
28 weeks
Involvement of genital area	2.64 (1.01–6.92)	0.048
Naïve/PBT	3.13 (1.16–8.33)	0.024
76 weeks
Anti-IL-12/IL-23 last therapy before guselkumab	0.19 (0.51–0.67)	0.010
Male sex	5.56 (1.15–25)	0.033
124 weeks
Anti-IL-12/IL-23 last therapy before guselkumab	0.18 (0.04–0.87)	0.033

Note: CI = confidence interval, OR = odds ratio, PASI = psoriasis area severity index, PBT = previous biologic treatment.

Analyzed variables: sex, age, age at disease onset, disease duration, weight, BMI, baseline PASI, number of comorbidities, number of previous biologic therapies, last class of biologic therapy, localization of disease in difficult-to-treat areas.

Table 4. Univariate logistic regression analysis of variables associated with PASI 100 response.

Variable	OR (95% CI)	P-value
12 weeks
Number of comorbidities	0.69 (0.47–0.99)	0.047
28 weeks
Number of previous biologic therapies	0.69 (0.51–0.94)	0.019
Naïve/PBT	5.55 (2.17–14.3)	0.000
Scalp involvement	2.35 (1.05–5.25)	0.038
52 weeks
Number of previous biologic therapies	0.62 (0.44–0.88)	0.008
Naïve/PBT	3.45 (1.16–10)	0.026
76 weeks
Number of previous biologic therapies	0.56 (0.37–0.83)	0.004
Naïve/PBT	4 (1.30–12.5)	0.026
BMI<30 kg/m^2	3.13 (1.18–8.33)	0.023
100 weeks
Male sex	3.70 (1.32–11.1)	0.013
Number of previous biologic therapies	0.64 (0.43–0.95)	0.028
124 weeks
Number of previous biologic therapies	0.50 (0.31–0.82)	0.005
BMI<30 kg/m^2	3.70 (1.14–12.5)	0.030

Note: CI = confidence interval, OR = odds ratio, PASI = psoriasis area severity index, PBT = previous biologic treatment.

Analyzed variables: sex, age, age at disease onset, disease duration, weight, BMI, baseline PASI, number of comorbidities, number of previous biologic therapies, last class of biologic therapy, localization of disease in difficult-to-treat areas.

Table 5. Multivariate logistic regression analysis (stepwise analysis) of predictors of PASI 75, PASI 90, and PASI 100 response after treatment with guselkumab.

Variable	OR (95% CI)	P-value
PASI 75 at week 4
Number of comorbidities	0.53 (0.34–0.84)	0.007
PASI 90 at week 4
Number of comorbidities	0.59 (0.35–0.99)	0.047
PASI 75 at week 12
Naïve/PBT	3.03 (1.16–7.69)	0.023
PASI 75 at week 28
Anti-IL-12/IL-23 last therapy before guselkumab	0.13 (0.03–0.70)	0.017
Anti-IL-17 last therapy before guselkumab	0.15 (0.03–0.75)	0.022
PASI 90 at week 28
Male sex	3.13 (1.08–9.09)	0.037
Anti-IL-17 last therapy before guselkumab	0.30 (0.10–0.84)	0.022
Involvement of genital area	3.71 (1.17–11.71)	0.025
PASI 100 at week 28
Naïve/PBT	5.26 (1.96–14.30)	0.001
PASI 90 at week 76
Anti-IL-12/IL-23 last therapy before guselkumab	0.16 (0.04–0.69)	0.014
PASI 100 at week 76
Number of previous biologic therapies	0.47 (0.28–0.81)	0.006
Involvement of scalp area	0.22 (0.06–0.87)	0.030
PASI 100 at week 100
Male sex	5.26 (1.54–20.00)	0.008

Figure 3. Drug survival rates for guselkumab monotherapy in the entire cohort (a) and grouped according to sex (b), BMI<30 or ≥30 kg/m² (c), or prior treatment with a biologic (d).

Figure 4. Response of a bio-naïve patient to guselkumab treatment over time. (a) Patient at presentation; (b) after 12 weeks of treatment; and (c) at week 160 of treatment. Consent to publish was obtained from the individual featured.

Figure 5. Response of a patient with multi-drug resistance, comorbidities, and BMI≥30 to guselkumab treatment over time. (a) Patient at presentation; (b) after 12 weeks of treatment; and (c) at week 180 of treatment. Consent to publish was obtained from the individual featured.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article.