
==== Front
Int J Womens Dermatol
Int J Womens Dermatol
JW9
International Journal of Women's Dermatology
2352-6475
Lippincott Williams & Wilkins Hagerstown, MD

IJWD-D-24-00013
00018
10.1097/JW9.0000000000000176
3
Original Research
Patient needs in women of childbearing age with psoriasis: retrospective analysis from the German PsoBest registry
da Silva Burger Neuza PhD a*
Augustin Matthias MD a
Westphal Lukas MSc a
Kühl Laura MSc a
Stephan Brigitte MD a
Sommer Rachel PD, PhD a
a Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
* Corresponding author. E-mail address: n.bernardinodasilvaburger@uke.de (N. da Silva Burger).
11 9 2024
10 2024
10 3 e176e176
21 2 2024
28 6 2024
Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of Women’s Dermatologic Society.
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Background:

Women of childbearing age (WoCBA) with psoriasis face additional burden related to contraindications of systemic treatments during pregnancy/lactation and to the physical and psychosocial impact of psoriasis on their intimate/sexual relationships.

Objective:

Within a people-centered health care model, this study aimed to identify specific patient needs and their correlates in WoCBA (18–45 years), in comparison to same-age men and women above 45 years.

Methods:

Baseline data from the German PsoBest registry, including patients with moderate/severe plaque-type psoriasis with the indication for systemic therapy, were retrospectively analyzed. Psoriasis severity was assessed with the Psoriasis Area and Severity Index and patient-reported outcomes included EuroQoL Visual Analogue Scale, Dermatology Life Quality Index (DLQI), and Patient Needs Questionnaire.

Results:

The participants were 2308 WoCBA, 3634 men between 18 and 45 years of age, and 3401 women older than 45 years. In comparison to both control groups, WoCBA reported more DLQI impairments and higher needs to reduce social impairments (eg, “to be able to lead a normal working life”; “to be less burdened in your partnership”; “to be able to have a normal sex life”). These patient needs were associated with having psoriasis arthritis, previous systemic therapy, worse general health, and more DLQI impairments.

Limitations:

Retrospective analysis of an established dataset limited the examination of specific developmental, sexual, and reproductive variables.

Conclusion:

The specific needs of WoCBA with psoriasis were particularly related to the work context/financial stability and intimate relationships, which are crucial aspects in family planning. These results claim for a sex/age-sensitive approach in the psoriasis health care, by considering these needs as qualifiers in the clinical decision for systemic treatment.

patient needs
people-centered care
PsoBest registry
psoriasis
women of childbearing age
UCB Biopharma SRLNot ApplicableOPEN-ACCESSTRUE
COUNTRYGERMANY
==== Body
pmcWhat is known about this subject in regard to women and their families?

Clinical decisions for systemic therapy of psoriasis in women of childbearing age are not straightforward because the newly available biologic drugs are not explicitly approved during pregnancy/lactation.

Along with the clinical measures, patient psychosocial impairments, childbearing preferences, and specific treatment needs must be taken into account in a shared decision-making process.

What is new from this article as messages for women and their families?

Women of childbearing age with plaque-type psoriasis and/or psoriatic arthritis reported higher quality of life impairments, compared to same-age men and women older than 45 years, which can reflect the cumulative burden of the disease manifestation, gender inequalities and stigmatization, and normative developmental tasks.

Women of childbearing age with psoriasis pursued both common and specific therapy goals, in comparison to other groups of patients. Specific patient needs of female patients of reproductive age were mostly related to reducing social impairments, for example, in the work environment and in intimate relationships.

The results from this study support a sex/gender- and age-sensitive approach in psoriasis health care, by identifying the patient needs that must be included in the shared decision-making for systemic treatment.

Introduction

Psoriasis is one of the most common dermatological diseases, with an estimated prevalence between 2 and 4% of the population in Western countries and 2.5% in Germany, affecting both sexes and all age groups and with 28.9% of patients of reproductive age.1,2 It is characterized by a chronic inflammation of the skin, with extensive redness and thick scales in typical, often visible, body areas, frequently associated with pruritus and high levels of psychosocial impairments.3–6 Psoriasis can be particularly burdensome for women of childbearing age (WoCBA) for several reasons. First, sex hormones have an important role in modulating the immune response. After puberty, the hormone fluctuations throughout the menstrual cycle, particularly in estrogen levels, have been associated with the onset and/or worsening of psoriasis.7 During pregnancy, around half of patients report improvement, a quarter show no changes, and a quarter report worsening of psoriasis symptoms; after delivery, about 65% of women develop a psoriasis flare-up.8 Second, the treatment options for psoriasis have changed substantially in the last 2 decades, but are still limited for those women who wish to conceive because none of the newly available biologic drugs are explicitly approved during pregnancy. Nevertheless, national and international guidelines refer to safety data of exposed pregnancies with a lack of risk signals, for example, in the case of tumor necrosis factor alpha-inhibitors.9 A third reason for high burden relates to the disease’s physical manifestations and locations (eg, psoriasis lesions in the anogenital area), as well as its psychosocial effects (eg, stigmatization), that may affect the establishment of intimate/sexual relationships,10–12 which are crucial in family planning.

Therefore, clinical decisions should not be based only on clinical scores, such as the Psoriasis Area and Severity Index (PASI)13 and body surface area,14 or even on functional quality of life (QoL) impairments (eg, Dermatology Life Quality Index [DLQI]15). In line with the people-centered model of care for psoriasis, patient preferences and values must be also taken into the equation.16 Recent publications advocate a sex/gender-sensitive approach in health care for psoriasis, first, by understanding sex differences in disease manifestation, severity, comorbidities, subjective disease perception, and impact on QoL; and, second, by considering these sex- and gender-related factors as qualifiers of systemic therapy decision-making in routine care.17,18

In this context, this study aimed at identifying the specific needs and treatment goals of WoCBA, by comparing this specific group of patients with same-age men and with women older than 45 years. Specific objectives were: (1) to estimate the percentage of WoCBA suffering from moderate-to-severe plaque-type psoriasis (PsO) or psoriasis arthritis (PsA), with an indication for systemic treatment; (2) to characterize the group of WoCBA in terms of sociodemographic characteristics, psoriasis clinical features, general health state, and QoL impairments, in comparison to other sex/age groups; (3) to comparatively examine the specific patient needs related to psoriasis treatment of WoCBA; and (4) to test the associations between clinical variables/patient-reported outcomes (PROs) of disease burden and patient needs, as well as the moderating effect of the study group on these associations.

Materials and methods

Study design and participants

PsoBest (NCT01848028) is a multicenter, prospective, noninterventional patient registry designed to acquire and evaluate long-term data on the efficacy, safety, and tolerability of biologic and nonbiologic systemic therapies for psoriasis with market approval in Germany.19 The PsoBest psoriasis registry obtained ethical approval from the Hamburg Chamber of Physicians (PV2805-1373-BO-ff from July 24, 2007, amended April 7, 2015 and July 20, 2022). Inclusion criteria are: age ≥ 18 years; diagnosis of moderate-to-severe PsO and/or PsA; being administered a specific systemic drug for the first time; written informed consent to participate; and sufficient German language skills. Patients lacking informed consent, with pure forms of intertriginous psoriasis or pustular psoriasis, or participating in a clinical trial on the day of admission are excluded.

The present study retrospectively analyzed baseline data from the patients enrolled in the PsoBest registry (first visit) between January 2008 and December 2021. Three groups of patients were selected for comparison analysis: women of childbearing age (ie, between 18 and 45 years of age), men between 18 and 45 years of age, and women older than 45 years. Additional exclusion criteria were: missing data on age and/or sex, current pregnancy/lactation, and early menopause (ie, before the age of 45 years).

Outcome measures

The PsoBest registry collected sociodemographic and clinical data via 2 standardized questionnaires to be completed by the physician and by the patient. The variables selected for this study that were retrieved from the physician questionnaire were: sex, age, current pregnancy/lactation, menopause, algorithmic diagnosis of PsO versus PsA, disease severity assessed by the PASI (range: 0–72),13 comorbidities, and previous exposure to systemic treatments. From the patient questionnaire, the following variables were selected: marital status, education level, employment, and year of psoriasis first diagnosis/disease duration, as well as the following PROs of disease burden:

EuroQoL Visual Analogue Scale (EQ-VAS)20: a generic measure that assesses the patient’s self-rated health status using a vertical visual analog scale (VAS) ranging from 0 (“worst imaginable health state”) to 100 (“best imaginable health state”).

DLQI15: skin-generic QoL questionnaire comprising 10 items, to be answered on a 4-point Likert response scale from 0 (“not relevant”/“not at all”) to 3 (“very much”). A total sum score (range: 0–30) was computed, with higher scores indicating larger impairments. The internal consistency (Cronbach α) in the current sample was 0.882.

Patient Needs Questionnaire (PNQ): part of the Patient Benefit Index21,22 that assessed the importance of individual needs regarding psoriasis treatment. It comprised 25 items rated within a 5-point Likert scale ranging from 0 (“not at all”/“does not apply to me”) to 4 (“very”). The 25 items were analyzed descriptively and mean scores were also computed for 5 subscales23: reducing physical impairments (Cronbach α = 0.683), reducing psychological impairments (Cronbach α = 0.862), reducing social impairments (Cronbach α = 0.851), reducing impairments due to therapy (Cronbach α = 0.756), and having confidence in healing (Cronbach α = 0.666).

Statistical analysis

The statistical analyses were performed with the IBM SPSS Statistics for Windows (SPSS, V.23.0, IBM Corp., Armonk, NY), assuming the critical P value (α) = .05 as the level of significance. For multiple pairwise comparisons, P values were adjusted using the Bonferroni method, to control for increased type-I error. Missing data were not replaced and were excluded using the listwise deletion method.

Descriptive statistics (mean [M] and standard deviation [SD] for continuous variables; absolute [n] and relative frequencies (%) for categorical variables) were calculated for sociodemographic and clinical variables, and the homogeneity between the groups was examined with independent samples t-tests (for continuous variables) or χ2 tests (for categorical variables). The sociodemographic and clinical variables that significantly differed between the groups were included as covariates in the following analyses.

The PROs of disease burden were compared between WoCBA and the 2 control groups using one-way uni- or multivariate analyses of covariance, for unidimensional (eg, DLQI) or multidimensional measures (eg, PNQ), respectively. Partial eta squared (ηp2) were presented as measures of effect sizes for the comparison analyses, considering ηp2 ≥ 0.01, ηp2 ≥ 0.06, and ηp2 ≥ 0.14 as small, medium, and large effects, respectively.24 Moreover, differences in the median scores of specific patient needs (PNQ items) were tested with nonparametric Mann–Whitney U tests.

Hierarchical regression analyses were performed to examine the main and interaction effects of clinical variables/PROs of disease burden and study group on PNQ subscales. To reduce multicollinearity, the continuous independent variables were mean-centered before computing the interaction terms.25,26 After the inclusion of sociodemographic confounders in the first step of the regression equation, the independent variables, the dummy-coded moderator, and the interaction terms were entered as predictors in subsequent steps.27 The significant interaction effects were plotted from data generated by the PROCESS Macro for SPSS,26 version 3.4 (model 1 with multicategorical moderator and including the remaining significant predictors as covariates).

Results

Sample characteristics

The psoriasis registry PsoBest, as of December 31, 2021, included a total of 13,825 patients, of which 2354 female patients were of childbearing age (17.0% of the total sample). Of these, 1970 (83.7% of the WoCBA; 14.2% of the total sample) were diagnosed with PsO and 384 (16.3% of the WoCBA; 2.8% of the total sample) with PsA. After excluding the female participants currently pregnant or breastfeeding and those with early menopause, the study group was composed of 2308 female patients of childbearing potential. The comparison groups were 3634 men between 18 and 45 years of age, and 3401 women older than 45 years of age who reported no current pregnancy/lactation. The sample selection is presented in Figure 1.

Fig. 1. Sample selection and assignment of patients to the study groups, based on inclusion/exclusion criteria.

The sociodemographic and clinical characteristics of the WoCBA, same-age men and women older than 45 years are presented comparatively in Table 1. In comparison to men between 18 and 45 years of age, WoCBA were, on average, slightly younger and more often unemployed; they were also more often diagnosed with PsA and had lower disease severity, but longer disease duration. Compared to women older than 45 years, WoCBA were more often unmarried, had higher education levels, and were more often employed; clinically, they were less often diagnosed with PsA, presented higher disease severity, shorter disease duration, less comorbidities, and were less often exposed to previous systemic therapy.

Table 1 Sociodemographic and clinical characteristics of women of childbearing age (18–45 years; group A), control groups of men between 18 and 45 years of age (group B), and women older than 45 years (group C)

	Group A: women 18–45 yr (n = 2308)	Group B: men 18–45 yr (n = 3634)	Group C: women > 45 yr (n = 3401)	A vs B	A vs C	
χ2/t (P)	χ2/t (P)	
Sociodemographic characteristics	
 Age (yr), mean ± SD	33.15 ± 7.40	34.28 ± 7.18	59.31 ± 9.16	−5.86 (<.001)	−114.27 (<.001)	
 Marital status, n (%)	
  Married	870 (37.7%)	1394 (38.4%)	2054 (60.4%)	0.344 (.557)	299.88 (<.001)	
  Unmarrieda	1354 (58.7%)	2100 (57.8%)	1213 (35.7%)	
  Missing	84 (3.6%)	140 (3.9%)	134 (3.9%)	
 Education level, n (%)	
  Low-mediumb	1384 (60.0%)	2100 (57.8%)	2640 (72.3%)	1.22 (.270)	166.63 (<.001)	
  Highc	755 (32.7%)	1221 (33.6%)	590 (17.3%)	
  Other/missing	169 (7.3%)	313 (8.6%)	351 (10.3%)	
 Employment, n (%)	
  Yes	1771 (76.7%)	3075 (84.6%)	1658 (48.8%)	71.38 (<.001)	648.86 (<.001)	
  No	463 (20.1%)	436 (12.0%)	1627 (47.8%)	
  Missing	74 (3.2%)	123 (3.4%)	116 (3.4%)	
Clinical characteristics	
 Diagnosis, n (%)	
  Plaque-type psoriasis	1931 (83.7%)	3138 (86.4%)	2494 (73.3%)	8.12 (.004)	84.23 (<.001)	
  Psoriasis arthritis	377 (16.3%)	496 (13.6%)	907 (26.7%)	
 Disease severity (PASI), mean ± SD	14.47 ± 10.02	15.78 ± 10.33	13.76 ± 9.77	−4.79 (<.001)	2.64 (.008)	
  Missing, n (%)	52 (2.3%)	84 (2.3%)	91 (2.7%)	
 Disease duration, mean ± SD	13.18 ± 10.12	11.81 ± 9.09	21.74 ± 17.89	5.24 (<.001)	−20.00 (<.001)	
  <2 yr	311 (13.5%)	478 (13.2%)	501 (14.7%)	0.15 (.702)	2.76 (.097)	
  ≥2 yr	1827 (79.2%)	2894 (79.6%)	2584 (76.0%)	
  Missing, n (%)	170 (7.4%)	262 (7.2%)	316 (9.3%)	
 Comorbidities, n (%)	
  Yes	1430 (62.0%)	2200 (60.5%)	2823 (83.0%)	1.20 (.274)	320.56 (<.001)	
  No	878 (38.0%)	1434 (39.5)	578 (17.0%)	
 Previous systemic treatment, n (%)	
  Yes	1433 (62.1%)	2340 (64.4%)	2264 (66.6%)	3.23 (.072)	12.09 (.001)	
  No	875 (37.9%)	1294 (35.6%)	1137 (33.4%)	
χ2, chi-squared test; P, asymptotic significance (2-tailed); SD, standard deviation; t, independent samples t-test.

a The “unmarried” group included the participants that were single, divorced, or widowed.

b “Low-medium” education level included the participants with unfinished studies or with secondary school certificate (“Hauptschulabschluss” or “Realschulabschluss”).

c “High” education level included the participants with high school certificate (“Fachhochschulreife” or “Abitur”).

PROs of disease burden

Compared to men between 18 and 45 years, while controlling for age, rate of employed participants, diagnosis, and disease severity and duration, WoCBA reported significantly worse general health (EQ-VAS), more skin-generic QoL impairments (DLQI), and rated patient-defined treatment needs as more important (PNQ, multivariate test: Wilks’ λ = 0.984, F(5;4629) = 15.04, P < 0.001, ηp2 = 0.016). The univariate analysis of covariance results are presented in Table 2.

Table 2 Comparison of PROs of disease burden between women of childbearing age (18–45 years; group A), control groups of men between 18 and 45 years of age (group B), and women older than 45 years (group C)

	Group A: women 18–45 yr	Group B: men 18–45 yr	ANCOVA A vs B	Group A: women 18–45 yr	Group C: women > 45 yr	ANCOVA A vs B	
	n	EMM ± SE	n	EMM ± SE	F (P)	Ƞ p 2	n	EMM ± SE	n	EMM ± SE	F (P)	Ƞ p 2	
EQ-VAS	2043	55.61 ± 0.48	3217	60.72 ± 0.38	69.09 (<.001)	0.013	1938	54.15 ± 0.53	2649	54.98 ± 0.44	1.31 (.252)	<0.001	
DLQI impairments	2065	14.18 ± 0.16	3272	11.63 ± 0.12	164.58 (<.001)	0.030	1690	13.82 ± 0.17	2718	12.00 ± 0.14	60.84 (<.001)	0.013	
PNQ reducing physical impairments	1787	3.08 ± 0.02	2853	2.85 ± 0.02	65.69 (<.001)	0.014	1696	3.09 ± 0.02	2160	3.17 ± 0.02	5.96 (.015)	0.002	
PNQ reducing psychological impairments	1787	2.78 ± 0.03	2853	2.54 ± 0.02	37.28 (<.001)	0.008	1696	2.83 ± 0.03	2160	2.91 ± 0.03	2.70 (.101)	0.001	
PNQ reducing social impairments	1787	2.55 ± 0.03	2853	2.33 ± 0.02	34.52 (<.001)	0.007	1696	2.56 ± 0.03	2160	2.27 ± 0.03	39.81 (<.001)	0.010	
PNQ reducing impairments due to therapy	1787	2.84 ± 0.03	2853	2.70 ± 0.02	18.04 (<.001)	0.004	1696	2.88 ± 0.03	2160	2.98 ± 0.03	5.38 (.020)	0.001	
PNQ having confidence in healing	1787	3.46 ± 0.02	2853	3.31 ± 0.02	29.48 (<.001)	0.006	1696	3.45 ± 0.02	2160	3.56 ± 0.02	12.34 (<.001)	0.003	
Ƞp2, partial eta squared; ANCOVA, analysis of covariance; DLQI, Dermatology Life Quality Index (range from 0 to 30, with higher scores indicating larger impairments); EMM, estimated marginal means, adjusted for the covariates included in the model; EQ-VAS, EuroQoL visual analogue scale (range from 0 to 100, where 0 corresponds to the “worst imaginable health state” and 100 corresponds to the “best imaginable health state”); F, univariate analysis of covariance; P, level of significance, 2-tailed; PNQ, Patient Needs Questionnaire (range from 0 to 4, with higher scores representing greater importance of patient needs); PRO, patient-reported outcome; SE, standard error.

Table 2 also displays the comparative analyses between WoCBA and women older than 45 years, controlling for marital status, education level, rate of employed women, diagnosis, disease severity and duration, presence of comorbidities, and proportion of patients who were previously exposed to systemic treatments. The results showed no significant differences in general health, but significant differences were found for DLQI impairments and patient needs (PNQ, multivariate test: Wilks’ λ = 0.958, F(5;3842) = 34.03, P < 0.001, ηp2 = 0.042), with women older than 45 years reporting higher needs to reduce physical impairments, to reduce impairments due to therapy, and to have confidence in healing; and WoCBA reporting more skin-generic QoL impairments and higher needs to reduce social impairments.

Specific patient-defined treatment needs

For all patients, the most relevant patient needs (ie, rated as “quite important” or “very important”) were “to be healed of all skin defects” (88.8%), “to get better skin quickly” (88.7%), “to regain control of the disease” (86.9%), and “to have confidence in the therapy” (86.1%). Regarding the comparative analysis between WoCBA and the control groups (Fig. 2), a similar pattern of patient needs was observed, with WoCBA rating most patient needs as more important than the same-age men, but as less important than women above 45 years. The exceptions were the needs of “to be able to lead a normal working life,” “to be more comfortable showing yourself in public,” “to be less burdened in your partnership,” and “to be able to have a normal sex life,” to which WoCBA attributed greater importance than the other 2 comparison groups.

Fig. 2. Comparison of specific patient needs between women of childbearing age (18–45 years; group A), control groups of men between 18 and 45 years of age (group B), and women older than 45 years (group C). Z, Mann–Whitney U tests: ‡P (asymptotic significance, 2-tailed) ≤.025 for comparison of women 18–45 years versus men 18–45 years; *P (asymptotic significance, 2-tailed) ≤.025 for comparison of women 18–45 years versus women >45 years. PNQ, Patient Needs Questionnaire.

Clinical variables and PROs of disease burden associated with patient needs

The hierarchical regression analyses (Table 3) showed that sociodemographic variables explained a small portion of the variance (2–3%) in patient-defined treatment needs, while clinical variables and PROs explained between 6% (“having confidence in healing”) and 32% (“reducing social impairments”) of their variance.

Table 3 Main and interaction effects of clinical variables/PROs of disease burden and study group on patient-defined treatment needs

	Patient needs (PNQ)	
	Reducing physical impairments	Reducing psychological impairments	Reducing social impairments	Reducing impairments due to therapy	Having confidence in healing	
	ß	t	ß	t	ß	t	ß	t	ß	t	
Step 1: sociodemographic confounders	ΔR2 = 0.02
ΔF(3;7069) = 53.17*	ΔR2 = 0.02
ΔF(3;7102) = 50.48*	ΔR2 = 0.02
ΔF(3;7121) = 39.83*	ΔR2 = 0.03
ΔF(3;7173) = 62.14*	ΔR2 = 0.02
ΔF(3;7242) = 36.84*	
 Marital statusa	−0.04	−3.10**	−0.05	−3.96*	−0.04	−3.73*	−0.03	−2.76**	−0.05	−4.19*	
 Education levelb	−0.12	−10.16*	−0.11	−9.52*	−0.10	−8.09*	−0.15	−12.34*	−0.11	−9.15*	
 Employmentc	−0.06	−5.41*	−0.06	−5.28*	0.08	6.94*	−0.04	−3.32**	−0.01	−1.15	
Step 2: main effects of clinical variables and PROs of disease burden	ΔR2 = 0.15
ΔF(7;7062) = 185.62*	ΔR2 = 0.29
ΔF(7;7095) = 426.37*	ΔR2 = 0.32
ΔF(7;7114) = 485.90*	ΔR2 = 0.09
ΔF(7;7166) = 107.07*	ΔR2 = 0.06
ΔF(7;7235) = 67.23*	
 Diagnosisd	0.12	10.33*	0.09	8.37*	0.05	4.96*	0.04	3.20**	0.01	0.63	
 PASI	0.02	1.83	−0.03	−3.12**	−0.01	−1.00	<0.01	0.38	−0.05	−4.54*	
 Disease duration	<0.01	0.32	0.05	5.01*	<0.01	0.02	0.05	4.20*	0.03	2.78**	
 Comorbiditiesc	0.03	2.86**	0.03	2.74**	−0.01	−0.99	0.02	1.41	0.02	1.33	
 Previous systemic treatmentc	0.02	1.30	0.04	4.36*	0.05	4.86*	0.06	5.15*	−0.02	−1.40	
 EQ-VAS	−0.08	−6.94*	−0.13	−11.44*	−0.05	−4.34*	−0.08	−6.29*	−0.05	−4.24*	
 DLQI impairments	0.32	26.04*	0.46	41.64*	0.54	49.66*	0.24	19.47*	0.23	17.77*	
Step 3: main effect of study group (moderator)	ΔR2 = 0.01
ΔF(2;7060) = 30.63*	ΔR2 < 0.01
ΔF(2;7093) = 17.03*	ΔR2 < 0.01
ΔF(2;7112) = 14.53*	ΔR2 < 0.01
ΔF(2;7164) = 12.29*	ΔR2 = 0.01
ΔF(2;7233) = 29.82*	
 WoCBA vs Men 18–45 years (group A vs B)	−0.04	−3.04**	<0.01	<0.01	0.01	0.92	−0.01	−0.82	−0.03	−1.73	
 WoCBA vs Women >45 yr (group A vs C)	0.07	4.71*	0.07	5.04*	−0.05	−4.12*	0.06	3.82*	0.09	5.62*	
Step 4: interaction effects	ΔR2 < 0.01
ΔF(14;7046) = 1.70***	ΔR2 < 0.01
ΔF(14;7079) = 3.28*	ΔR2 < 0.01
ΔF(14;7098) = 1.49	ΔR2 < 0.01
ΔF(14;7150) = 1.11	ΔR2 < 0.01
ΔF(14;7219) = 0.67	
 Diagnosisd*** (group A vs B)	<−0.01	−0.12	−0.01	−0.63	−0.03	−1.60	−0.03	−1.51	−0.02	−0.91	
 Diagnosisd,*** (group A vs C)	−0.01	−0.68	<0.01	<0.01	<0.01	0.23	−0.02	−0.97	0.01	0.33	
 PASI*** (group A vs B)	0.03	1.66	<0.01	<−0.01	−0.02	−1.11	−0.01	−0.33	−0.01	−0.40	
 PASI*** (group A vs C)	<−0.01	−0.18	0.01	0.73	<0.01	0.25	<0.01	0.23	<0.01	0.03	
 Disease duration*** (group A vs B)	0.01	0.60	<0.01	0.26	<0.01	0.27	−0.01	−0.64	<−0.01	−0.05	
 Disease duration*** (group A vs C)	0.01	0.50	−0.05	−1.99***	−0.01	−0.30	−0.03	−1.22	−0.02	−0.73	
 Comorbiditiesc*** (group A vs B)	0.01	0.50	0.01	0.38	0.01	0.33	−0.02	−0.66	−0.02	−0.90	
 Comorbiditiesc*** (group A vs C)	0.03	0.96	−0.05	−1.85	−0.05	−1.99***	−0.02	−0.52	−0.04	−1.29	
 Previous systemic treatmentc,*** (group A vs B)	0.04	1.37	0.05	2.08***	0.02	0.97	0.01	0.49	0.05	1.84	
 Previous systemic treatmentc*** (group A vs C)	−0.02	−0.91	0.07	2.83**	0.04	1.73	<0.01	0.10	0.05	1.80	
 EQ-VAS*** (group A vs B)	0.01	0.41	0.03	1.62	0.01	0.34	0.01	0.71	−0.01	−0.38	
 EQ-VAS*** (group A vs C)	−0.03	−1.57	<−0.01	−0.11	<−0.01	−0.21	<−0.01	−0.21	−0.01	−0.32	
 DLQI impairments*** (group A vs B)	0.03	1.34	0.04	2.15***	0.02	1.11	0.01	0.39	<−0.01	−0.19	
 DLQI impairments*** (group A vs C)	−0.01	−0.64	−0.04	−2.35***	−0.02	−0.98	0.04	2.03***	−0.02	−0.95	
Model summary	R2 = 0.18
F(26;7046) = 61.07*	R2 = 0.32
F(26;7079) = 127.25*	R2 = 0.34
F(26;7098) = 140.19*	R2 = 0.12
F(26;7150) = 38.40*	R2 = 0.08
F(26;7219) = 25.44*	
ß, standardized coefficients; DLQI, Dermatology Life Quality Index; EQ-VAS, EuroQoL visual analogue scale; PASI, Psoriasis Area and Severity Index; PNQ, Patient Needs Questionnaire; PRO, patient-reported outcome; WoCBA, women of childbearing age.

a 0 = married, 1 = unmarried.

b 0 = low-medium, 1 = high.

c 0 = no, 1 = yes.

d 0 = plaque-type psoriasis, 1 = psoriasis arthritis.

* P ≤ .001;

** P ≤ .01;

*** P ≤ .05; 2-tailed.

The diagnosis of PsA, presence of comorbidities, worse general health, and more DLQI impairments were significantly associated with increased patient needs related to reducing physical impairments, for all groups of patients. Higher needs to reduce psychological impairments were significantly associated with having the diagnosis of PsA, decreased disease severity, presence of comorbidities, and worse general, for all groups of patients. In addition, longer disease duration was associated with higher needs in the psychological domain for women and men between 18 and 45 years, but not for women older than 45 years (Fig. 3A); previous systemic treatment was associated with higher needs in the control groups, but not in the group of WoCBA (Fig. 3B); and the link between DLQI impairments and the PNQ subscale, although significant for all groups, was stronger for men aged 18 to 45 years (Fig. 3C). The variables associated with increased patient needs to reduce social impairments were the diagnosis of PsA, previous systemic therapy, worse general health, and more QoL impairments. In addition, the presence of comorbidities was associated with lower needs in the social domain for the group of women older than 45 years (Fig. 3D). The variance in patient needs of reducing impairments due to therapy was mainly explained by having the diagnosis of PsA, longer disease duration, previous exposure to systemic therapy, worse general health, and more DLQI impairments (with a stronger association for the group of women older than 45 years; Fig. 3E). Finally, increased patient needs to have confidence in healing were associated with lower PASI, longer disease duration, worse general health, and more DLQI impairments, with no moderation effects of the study group.

Fig. 3. The moderating effect of the study group (women between 18 and 45 years vs men between 18–45 years vs women older than 45 years) on the associations between clinical variables/patient-reported outcomes of disease burden and patient-defined treatment needs (PNQ subscales). (A) Moderating effect of study group on the associations between disease duration and patient needs of reducing psychological impairments. (B) Moderating effect of study group on the associations between previous systemic treatment and patient needs of reducing psychological impairments. (C) Moderating effect of study group on the associations between DLQI impairments and patient needs of reducing psychological impairments. (D) Moderating effect of study group on the associations between comorbidities and patient needs of reducing social impairments. (E) Moderating effect of study group on the associations between DLQI impairments and patient needs of reducing impairments due to therapy. PNQ, Patient Needs Questionnaire.

Discussion

The main contributions of the present study were the ascertainment of higher disease burden, in terms of QoL impairments, and the identification of specific treatment needs in WoCBA with psoriasis, in comparison to same-age men and women above 45 years. This study was strengthened by the use of a large dataset, the German PsoBest registry, which included patients with moderate-to-severe plaque-type psoriasis who are initiating a specific systemic therapy, across all of Germany. Of a total of 13,825 patients included in the registry, 5988 (43.3%) were in their reproductive years and 2354 (17.0%) were female patients of childbearing age. This result, together with a peak for age at onset in women around 20 to 29 years,1 highlights the importance of examining the impact of the disease in the overall psychosocial adaptation of this specific group of patients.

The first set of comparative analyses showed that WoCBA had lower disease severity, but reported significantly worse general health and more QoL impairments, than same-age men. Compared to women older than 45 years, WoCBA presented higher disease severity and reported more DLQI impairments, but no significant differences were found for general health. The results for general health might be explained by sex, as previous studies have consistently showed that women tend to report significantly poorer health than men on self-reported measures.28,29 On the contrary, the greater DLQI impairments seem to be specific to the group of WoCBA, as they scored higher than both comparison groups and, thus, these differences cannot be explained neither by sex nor by aging. The higher QoL impairments in WoCBA might be explained by the cumulative burden of the disease manifestation, particularly when visible or sexually-sensitive body areas are affected,30 gender inequalities and higher stigmatization experienced by women,31 and the challenging normative developmental tasks inherent to emerging adulthood, such as transition from the educational system to the work environment, establishment of long-lasting intimate relationships and family planning/transition to parenthood.32

The needs rated as more important by WoCBA, and also by the other patient groups, were mainly related to reducing physical impairments and having confidence in healing. The treatment options that are effective in reducing symptoms are of extreme importance for all patients, independently of sex and age. In WoCBA, this raises concerns about the contraindications of several biologic systemic drugs in conception planning/pregnancy and calls for the establishment of clear guidelines for psoriasis treatment in pregnancy/lactation, and also for the importance of addressing family planning issues with the patients, in a truly shared decision-making process.33 In addition, WoCBA rated the needs of reducing social impairments as more important than both comparison groups. Increased needs to reduce social impairments were associated with being married, lower education levels, being employed, having the diagnosis of PsA, previous systemic therapy, worse general health, and more QoL impairments. These correlates placed the specific needs of WoCBA in context: being married generates the need of being less burdened in the partnership and of being able to have a normal sex life; the job context brings the wish of having a normal working life and of being more comfortable in public. And these needs got more important as the impact of psoriasis on general health and functional impairments increased. Although these correlates were significant for all groups and not specific for WoCBA, being married or in a solid partnership, having financial stability, and being healthy and functional can be considered prerequisites when it comes to the decision of having children.

The retrospective analysis of an established dataset entails some methodological limitations that should be taken into account. First, only cross-sectional data from the first visit were used, which prevented the establishment of causal associations between the patient and disease characteristics and the treatment needs, as well as the examination of treatment benefits in women under successful therapy. Second, patients with pure forms of intertriginous and pustular psoriasis were excluded, though the involvement of the inguinal folds and hands has a great impact on social and intimate relationships. A third limitation relates to the exclusion of patients who reported current pregnancy/breastfeeding because of the small number (n = 21) and their wide age range, with 23.8% of patients older than 45 years. Fourth, the study groups encompassed great intragroup variability and the absence of data on specific developmental and reproductive variables (eg, relationship status, short- and long-term planning of pregnancy, fertility problems, use of assisted human reproduction techniques, contraception) that can impact disease burden and treatment needs of the patients prevented further stratification of the sample. Finally, the PROs of disease burden were limited to general health (EQ-VAS) and QoL impairments (DLQI); additional PROs, for example, Hospital Anxiety and Depression Scale34 and the SF-12,35 were included in the PsoBest registry in 2014 but the sample size for these PROs was considerably smaller, and they were, therefore, not used in the current analysis. Studies specifically designed to assess disease burden and patient needs in this vulnerable group of patients, considering specific reproductive variables and their interactions with treatment choices and benefits, as well as further indicators of disease burden pertaining to the domain of social and intimate/sexual relationships, are necessary to offer a people-centered care for psoriasis.

Despite these limitations, this study provided initial evidence that WoCBA with psoriasis pursue similar therapy goals, namely reducing physical impairments and having confidence in the therapy, but also distinctive goals, namely reducing social impairments, in comparison to other groups of patients. By identifying the specific treatment needs of WoCBA with psoriasis, this study contributed to a better understanding of sex and age specificities that should be considered in the decision-making process for systemic treatment, within a gender-sensitive approach in psoriasis health care.17,18 In order to take these patient needs into account and offer the best support in terms of effective and satisfactory treatment outcomes for this vulnerable group, a holistic approach that considers not only clinical factors but also psychological and social living conditions is required.

Conflicts of interest

The authors made the following disclosures: M.A. and B.S. participated in clinical trials and received honorary fees and financial support for scientific lectures and presentations at national and international congresses from UCB Biopharma SRL, as well as from other pharmaceutical companies. R.S. received speaker and travel honoraria from UCB Biopharma SRL. The other authors declare no conflicts of interest.

Funding

Supported by UCB Biopharma SRL.

Study approval

This work is part of the project “Impact of psoriasis on patient needs, preferences, stigmatization, disfigurement and self-esteem in young women at childbearing age (WoCBA): A contribution to differentiation in therapy” (PsoFem), which was approved by the Ethics Committee of the University Medical Center Hamburg-Eppendorf (Lokale Psychologische Ethikkommission am Zentrum für Psychosoziale Medizin [LPEK-0330, June 11, 2021]).

Author contributions

NSB contributed to the study conceptualization, data curation, formal analysis, discussion of results, and writing of the initial draft of the manuscript. LW contributed to the study conceptualization, preliminary analysis, discussion of results, and writing of the initial draft of the manuscript. BS contributed to the study conceptualization, discussion of results, and critical review and editing of the manuscript. LK contributed to data curation, formal analysis, discussion of results, and critical review and editing of the manuscript. MA and RS contributed to the study conceptualization, funding acquisition, project administration and supervision, discussion of results, and critical review and editing of the manuscript. All authors reviewed the final version of the manuscript, approved it for submission, and agreed to take public responsibility for its content.

Data availability

Data and other materials are available upon request from the corresponding author.

Acknowledgments

We would like to thank the PsoBest team, in particular Stephan Jeff Rustenbach, for providing the PsoBest dataset and supporting the data management. We thank UCB, in particular, Inés Dueñas Pousa and Frederik Fierens, for their courtesy review of the manuscript. We also thank the Scientific Communication Team of the IVDP, in particular Merle Twesten, for copy editing. We acknowledge financial support from the Open Access Publication Fund of UKE (Universitätsklinikum Hamburg-Eppendorf) and DFG (German Research Foundation).

Published online 11 September 2024

B.S. and R.S. shared last authorship.
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