Effect of Sex in Systemic Psoriasis Therapy: Differences in Prescription, Effectiveness and Safety in the BIOBADADERM Prospective Cohort

Hernández-Fernández, Carlos Pelayo; Carretero, G.; Rivera, R.; Ferrándiz, Carlos; Daudén, Esteban; Cueva, Pablo de la; Belinchón, I.; Gómez-García, F.J.; Herrera‐Acosta, Enrique; Ruíz‐Genao, Diana; Ferrán, Marta; Alsina, M.; Baniandrés‐Rodríguez, Ofelia; Sánchez‐Carazo, J.L.; Botella‐Estrada, Rafael; Sahuquillo‐Torralba, Antonio; Rodríguez, Lourdes; Vilar-Alejo, Jaime; García‐Donoso, Carmen; Carrascosa, J.M.; Llamas‐Velasco, Mar; Herrera‐Ceballos, Enrique; López‐Estebaranz, José Luis; Pujol-Marco, Conrad; Descalzo, M.Á.; García‐Doval, I.

doi:10.2340/00015555-3711

Cited by 16 publications

(30 citation statements)

References 32 publications

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“…This latter observation is also in line with the literature. 24 We hypothesize that this may be related to the reported lower satisfaction with treatment among women with psoriasis, 6 , 10 which is confirmed by our results, showing at enrolment significantly lower scores among women for all TSQM-9 domains.…”

Section: Discussionsupporting

confidence: 80%

“…Twice as many women as men were treated with systemic drugs other than biologics, in line with previous data, showing that women are more likely than men to be prescribed biologics and overall systemic therapy. 24 Although there were no relevant differences in the duration of illness, more women than men had been previously treated with biologics (50% vs. 47%) and women had also received more previous biological treatment lines. This latter observation is also in line with the literature.…”

Section: Discussionmentioning

confidence: 83%

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The CANOVA Study Real-World Evidence of Biologic Treatments in Moderate-Severe Psoriasis in Italy: A Gender Perspective

Colombo

Bianchi

Fabbrocini³

et al. 2022

Women's Health Reports

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Background: In psoriasis, several studies have indicated sex differences in clinical characteristics, type of treatment, and outcomes. A higher impact of psoriasis on quality of life (QoL) and a lower treatment satisfaction have been reported in women by different authors. Objectives: This article reports the results of a post hoc gender analysis of CANOVA study, aimed at assessing 16/24/52-week effectiveness of biologics in patients with moderate-severe plaque psoriasis. Materials and Methods: CANOVA was a real-world, multicenter, noninterventional, retro-prospective study conducted in 17 Italian hospital dermatology clinics. Results: Of the 669 eligible patients, 63.8% were men. Demographic and baseline characteristics and duration of disease were rather homogeneous between sexes. Slightly more women had been treated with biologics (50.4% vs. 46.5%) and had received ≥2 biologic treatment lines (17.2% vs. 12.4%) before study treatment. The most frequently used biologics were secukinumab, ustekinumab, adalimumab, and ixekizumab in both sexes. At 6 months, Psoriasis Area Severity Index (PASI) 75/90/100 responders were 90.8%/72.3%/45.3% of men and 89.2%/76.6%/48.2% of women. Sustained PASI responders were 79.5% of men and 75.9% of women. Treatment satisfaction was significantly lower in women at enrolment for all subscales, and was still lower at 6 months, no longer significantly. Gender distribution in Dermatology Life Quality Index total score classes showed a significantly greater effect of psoriasis on QoL in women, both at enrolment and at the 6-month follow-up. Conclusions: In conclusion, this gender analysis confirms in both genders the efficacy of biologics in psoriasis. However, women reported a greater impact of the disease on QoL and lower treatment satisfaction.

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Section: Discussionsupporting

confidence: 80%

Section: Discussionmentioning

confidence: 83%

The CANOVA Study Real-World Evidence of Biologic Treatments in Moderate-Severe Psoriasis in Italy: A Gender Perspective

Colombo

Bianchi

Fabbrocini³

et al. 2022

Women's Health Reports

View full text Add to dashboard Cite

show abstract

“… 101 In a Spanish registry study, however, treatment effectiveness of systemic treatment was similar in women and men. 100 Regarding side effects, women were more likely to experience acute infections during treatment with biologic drugs in an Italian study ( n = 167, 63.4% men) and more side effects in a Spanish study ( n = 2881, 58.3% men) when treated with a systemic agent. 100 , 102 …”

Section: Resultsmentioning

confidence: 98%

“… 58 Contrarily to this, in a Spanish cohort study ( n = 2881; 58.3% men), women had a 33% higher chance of being prescribed a modern therapeutic agent. 100 In a 2-country, multicenter, prospective, noninterventional registry study ( n = 5346, 67.3% male) evaluating gender differences regarding systemic antipsoriatic treatment, women had a higher PASI response and were more likely to achieve a DLQI reduction of ≥4. 101 In a Spanish registry study, however, treatment effectiveness of systemic treatment was similar in women and men.…”

Section: Resultsmentioning

confidence: 99%

The impact of gender and sex in psoriasis: What to be aware of when treating women with psoriasis

Guillet

Seeli

Meienberger

et al. 2022

International Journal of Women’s Dermatology

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Background: Psoriasis is a common chronic inflammatory skin disease with an exceptionally high burden for women. Objective: Sex-dependent differences in disease manifestation, severity, treatment choices, subjective disease perception, and the impact on quality of life and risk factors are described and comprehensively discussed. Methods: A literature search was conducted using MEDLINE (PubMed) and the Cochrane Library for systematic reviews to investigate the challenges in treating women with psoriasis. Results and conclusions: The incidence, prevalence, and manifestation of psoriasis of the skin are similar between different sexes. Genetic and environmental factors such as obesity and metabolic syndrome are risk factors and are not equally relevant or pronounced in women and men. Overall, women have a lower disease severity measured by the Psoriasis Area Severity Index, which is associated with a higher impairment of their life quality measured by the Dermatology Life Quality Index compared with men. In addition, women with psoriasis are more likely to have depression than men. Hormonal factors affect psoriasis, with a correlation of high estrogen levels and improvement of psoriasis. Data regarding differences in prescribing patterns of systemic treatments and the severity of psoriasis are not entirely consistent. Registry studies show that men tend to have more severe psoriasis and, in some cases, are prescribed systemic therapies more frequently. Women tend to respond better to systemic treatments and to experience more adverse events. Treatment options are the same for both sexes, except during pregnancy and lactation. Various treatment options are contraindicated due to fear of fetal or neonate harm and lack of data. Topical steroids can be prescribed with a high degree of safety during pregnancy. For other topical therapies (calcineurin inhibitors and vitamin D analogs), no studies of adverse effects in pregnancy are available, and safety data mainly stem from studies examining effects after systemic administration. Antitumor necrosis factor monoclonal antibodies (except for certolizumab pegol) have been associated with a possible increased risk of preterm birth, low gestational age, and cesarean deliveries. Prospective data on the safety of biologics other than antitumor necrosis factor-alpha antibodies to accurately assess whether novel biologics (eg, anti-interleukin 17, 12/23, 23) can be used for systemic therapy in pregnancy are lacking or currently being conducted.

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“…In this study, patient subgroups were prespecified a priori in the protocol and defined according to seven clinically relevant demographic and disease variables with binary categories: (i) sex (male or female) [11,[18][19][20], (ii) age (\ 65 or C 65 years) [13,14], (iii) body mass index (BMI [B 30 or [ 30 kg/m 2 ]) [19][20][21], (iv) race (White or Asian) [4,[22][23][24][25], (v) PsO disease duration (\ 15 or C 15 years) [13,20], (vi) PsA comorbidity (present or absent) [13,20,26], and (vii) prior biologic use (never or C 1) [8,20,27,28]. Across all subgroup categories, pairwise effectiveness comparisons were completed for the anti-IL-17A cohort versus the other biologics cohort and for IXE versus the other individual biologics.…”

Section: Study Design and Assessmentsmentioning

confidence: 99%

Comparative Effectiveness of Biologics Across Subgroups of Patients with Moderate-to-Severe Plaque Psoriasis: Results at Week 12 from the PSoHO Study in a Real-World Setting

et al. 2022

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Introduction:In routine clinical care, important treatment outcomes among patients with moderate-to-severe plaque psoriasis (PsO) have been shown to vary according to patient demographics and disease characteristics. This study aimed to provide direct comparative effectiveness data at week 12 between anti-interleukin (IL)-17A biologics relative to other approved biologics for the treatment of PsO across seven clinically relevant patient subgroups in the real-world setting. Methods: From the international, non-interventional Psoriasis Study of Health Outcomes (PSoHO), 1981 patients with moderate-to-severe PsO were grouped a priori according to seven clinically relevant demographic and disease variables with binary categories, which were sex

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Effect of Sex in Systemic Psoriasis Therapy: Differences in Prescription, Effectiveness and Safety in the BIOBADADERM Prospective Cohort

Cited by 16 publications

References 32 publications

The CANOVA Study Real-World Evidence of Biologic Treatments in Moderate-Severe Psoriasis in Italy: A Gender Perspective

The CANOVA Study Real-World Evidence of Biologic Treatments in Moderate-Severe Psoriasis in Italy: A Gender Perspective

The impact of gender and sex in psoriasis: What to be aware of when treating women with psoriasis

Comparative Effectiveness of Biologics Across Subgroups of Patients with Moderate-to-Severe Plaque Psoriasis: Results at Week 12 from the PSoHO Study in a Real-World Setting

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