Response to fumaric acid esters for plaque type psoriasis in real-world practice is largely independent of patient characteristics at baseline – a multivariable regression analysis from the German Psoriasis Registry PsoBest

Figures & data

Figure 1. Patient flow. The analysis is based on a cohort drawn from the German Psoriasis Registry PsoBest including 444 patients who had received fumaric acid esters (FAEs) treatment and met a minimal observation time of 12 months in the registry. *10–14 months after inclusion.

Table 1. Baseline demographics and disease characteristics.

	N	n (%)	Mean (SD)	Median (min–max)
Age (years)	444	–	47.0 (14.7)	47.0 (18.0 − 82.0)
Female sex	444	173 (39.0)	–	–
Weight (kg)	438	–	87.0 (20.2)	84.0 (48.0 − 180.0)
BMI (kg/m²)	438	–	28.7 (6.1)	27.6 (17.3 − 51.9)
Waist–hip ratio	430	–	0.9 (0.1)	0.9 (0.6 − 1.6)
Duration of illness (years)	406	–	14.8 (13.6)	11.0 (0.0 − 63.0)
Positive family history	422	146 (34.6)	–	–
PASI	444	–	14.5 (7.8)	12.7 (3.3 − 48.3)
BSA	438	–	22.0 (17.2)	16.0 (1.0 − 100)
DLQI	423	–	10.4 (6.8)	9.0 (0.0 − 30.0)
Nail psoriasis (≥1 fingernails involved)	444	201 (45.3)	–	–
Psoriatic arthritis	444	19 (4.3)	–	–
Cardiovascular disease	444	136 (30.6)	–	–
Metabolic disease	444	89 (20.0)	–	–
Liver disease	444	18 (4.1)	–	–
Psychiatric and addiction disease^a	444	44 (9.9)	–	–
Prior phototherapy	444	174 (39.2)	–	–
Prior systemic nonbiologic treatment (other than FAE)	444	64 (14.4)	–	–
Prior biologic treatment	444	3 (0.7)	–	–

PASI: Psoriasis Area and Severity Index; DLQI: Dermatology Life Quality Index; BSA: body surface area; BMI: body mass index; SD: standard deviation.

^a Smoking is not included.

Figure 2. Therapeutic effectiveness of fumaric acid esters (FAEs) at 12 months. Therapeutic response to FAEs treatment was defined as Psoriasis Area and Severity Index (PASI) ≤ 3 at 12 months or a treatment stop due to skin clearance. Nonresponder imputation (n = 444) and observed cases (n = 321) is shown.

Table 2. Treatment effect modifiers of response to fumaric acid esters (FAEs).

Baseline variables	B	p value	Odds ratio [Exp(B)]	95% CI for Exp(B)
				Lower limit	Upper limit
Age (years)	1.24 × 10^−2	≤.213	1.012	0.993	1.032
Female sex	−4.04 × 10^−1	≤.151	0.668	0.385	1.158
Weight (kg)	−5.38 × 10^−3	≤.464	0.995	0.980	1.009
Duration of illness (years)	−1.58 × 10^−4	≤.987	1.000	0.981	1.019
Baseline PASI category	–	≤.001	–	–	–
PASI < 10	1.408	≤.001	4.088	1.973	8.469
PASI 10–20	6.74 × 10^−1	≤.044	1.961	1.018	3.779
PASI > 20	Reference category
Concomitant cardiovascular disease	7.41 × 10^−2	≤.812	1.077	0.585	1.982
Concomitant metabolic disease	−8.14 × 10^−2	≤.814	0.922	0.467	1.819
Concomitant liver disease	−4.00 × 10^−1	≤.559	0.670	0.175	2.566
Concomitant psychiatric or addictive disease	6.41 × 10^−1	≤.175	1.889	0.752	4.795
Systemic pretreatment	−2.03 × 10^−1	≤.592	0.817	0.389	1.712

PASI: Psoriasis Area and Severity Index. B: coefficient for the constant in the null model (logistic regression without variable selection after initial modeling); Exp(B): exponentiation of the B coefficient, which is an odds ratio; 95% CI: 95% confidence interval.

Therapeutic response to FAEs treatment was defined as PASI ≤ 3 at 12 months or a treatment stop due to skin clearance.

Figure 3. Distribution of Psoriasis Area and Severity Index (PASI) baseline scores in responders (A) and nonresponders (B) at 12 months. Patients eligible for response analysis had a minimum PASI > 3 at baseline. Therapeutic response to FAEs treatment was defined as PASI ≤ 3 at 12 months or a treatment stop due to skin clearance. Responders (n = 176), nonresponders (n = 145). Presented data are rounded.

Data availability statement

All data generated or analyzed during this study are included in the published article.