Meta-analysis results do not reflect the real safety of biologics in psoriasis.

BACKGROUND: In reported systematic reviews and meta-analyses of randomized controlled trials (RCTs) assessing treatments for psoriasis, the proportion of serious adverse events (SAEs) did not differ between treatments and placebo. Including cases of psoriasis worsening as SAEs may explain the lack of difference. OBJECTIVES: This systematic review and meta-analysis aimed to explore this possibility. METHODS: Among the 140 RCTs included in the Living Network Cochrane Review (last search on 8 May 2019), we selected those comparing a biologic treatment against placebo. The primary outcome was the numbers of SAEs in the treatment and placebo arms after excluding cases of psoriasis worsening. Secondary outcomes were the number of adverse events (AEs) of special interest. The trial was registered on PROSPERO (CRD42019124495). RESULTS: We analysed 51 RCTs. Of these, 21 included at least one anti-tumour necrosis factor (TNF)-α arm, 15 one anti-interleukin (IL)-17 arm, 11 one anti-IL-23 arm and nine one anti-IL-12/23 arm. With cases of psoriasis worsening included, the risk of occurrence of SAEs between biologic treatments and placebo did not differ: risk ratio (RR) 1·09, 95% confidence interval (CI) 0·88-1·36. After excluding cases of psoriasis worsening, the RR became significant (RR 1·30, 95% CI 1·02-1·65). By drug class, the RRs were for anti-TNF-α, 1·68 (95% CI 1·11-2·54; no missing data); anti-IL-17, 1·28 (95% CI 0·88-1·85; no missing data); anti-IL-23, 0·95 (95% CI 0·59-1·52; no missing data) and anti-IL-12/23, 1·18 (95% CI 0·72-1·94; no missing data). We were unable to examine potential differences in AEs of special interest between biologic treatments and placebo arms because of the small number of events. CONCLUSIONS: On excluding cases of worsening psoriasis, the risk of occurrence of SAEs is higher in the biologic than in the placebo arm. Given the rare events, we could not highlight whether this higher risk of SAEs was related to AEs of special interest. Reporting of SAEs in clinical trials has to be changed to provide more transparency through the separate reporting of disease flares leading to hospital admission and other SAEs.

Illness perceptions and quality of life in families with child with atopic dermatitis

OBJECTIVE: To assess the Quality of Life (QoL) of children with Atopic Dermatitis (AD) and their families and the impact of the mothers' illness perceptions on the family QoL. MATERIALS AND METHODS: Seventy-five children with AD (54 infants and 21 children) and their mothers participated in the study. The following questionnaires were administrated: 1. Brief Illness Perception Questionnaire (Brief IPQ); 2. Infant's Dermatitis Quality of Life Index (IDQOL); 3. Children's Dermatology Life Quality Index (CDLQI); 4. Dermatitis Family Impact Questionnaire (DFIQ) and 5. The Severity Scoring of Atopic Dermatitis (SCORAD). RESULTS: Atopic dermatitis had a moderate impact on the QoL of the infants (6.67 ± 5.30), children (7.86 ± 7.19) and their families (9.42 ± 7.03). The DFIQ was associated with certain dimensions of the Brief IPQ, specifically, with Illness Identity (greater symptom burden) (r = 0.615, p = 0.000), beliefs about the Consequences of the illness (r = 0.542, p = 0.000), the Concerns (r = 0.421, p = 0.000) and the Emotional Representations (r= 0.510, p = 0.000). Correlation was demonstrated between IDQOL and DFIQ (r = 0.662, p = 0.000) and between CDLQI and DFIQ (r = 0.832, p = 0.000), and a weaker correlation between SCORAD and DFIQ (r = 0.255, p = 0.035). The chronicity of the AD showed negative association with DFIQ (p < 0.001). CONCLUSIONS: The QoL of families with a child with AD is associated with the mother's illness perceptions about AD, the children's QoL and with both the severity and the chronicity of the disease. Therefore, clinicians should pay attention not only to the clinical characteristics of the children, but also to the parents' beliefs and emotions, to improve the family QoL

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Illness perceptions and quality of life in families with child with atopic dermatitis.

OBJECTIVE: To assess the Quality of Life (QoL) of children with Atopic Dermatitis (AD) and their families and the impact of the mothers' illness perceptions on the family QoL. MATERIALS AND METHODS: Seventy-five children with AD (54 infants and 21 children) and their mothers participated in the study. The following questionnaires were administrated: 1. Brief Illness Perception Questionnaire (Brief IPQ); 2. Infant's Dermatitis Quality of Life Index (IDQOL); 3. Children's Dermatology Life Quality Index (CDLQI); 4. Dermatitis Family Impact Questionnaire (DFIQ) and 5. The Severity Scoring of Atopic Dermatitis (SCORAD). RESULTS: Atopic dermatitis had a moderate impact on the QoL of the infants (6.67±5.30), children (7.86±7.19) and their families (9.42±7.03). The DFIQ was associated with certain dimensions of the Brief IPQ, specifically, with Illness Identity (greater symptom burden) (r=0.615, p=0.000), beliefs about the Consequences of the illness (r=0.542, p=0.000), the Concerns (r=0.421, p=0.000) and the Emotional Representations (r=0.510, p=0.000). Correlation was demonstrated between IDQOL and DFIQ (r=0.662, p=0.000) and between CDLQI and DFIQ (r=0.832, p=0.000), and a weaker correlation between SCORAD and DFIQ (r=0.255, p=0.035). The chronicity of the AD showed negative association with DFIQ (p<0.001). CONCLUSIONS: The QoL of families with a child with AD is associated with the mother's illness perceptions about AD, the children's QoL and with both the severity and the chronicity of the disease. Therefore, clinicians should pay attention not only to the clinical characteristics of the children, but also to the parents' beliefs and emotions, to improve the family QoL.