Anti-TNF agents for paediatric psoriasis

Abstract

Cochrane Database of Systematic Reviews Index (CDLQI), and adverse e ects. Our secondary outcomes included the proportion of participants achieving PASI 50 and the Physician's Global Assessment (PGA). Main results We included one study with 211 participants (median age 13 years), in which etanercept (dosage ranged from 0.8 to 50 mg per kilogram of body weight) was compared to placebo. Follow-up was over a 48-week period. At week 12, 57% versus 11% who received etanercept or placebo, respectively, achieved the PASI 75 (risk ratio 4.95, 95% confidence interval (CI) 2.83 to 8.65; high-quality evidence). Absolute risk reduction and the number needed to treat to obtain a benefit with etanercept was 45% (95% CI 33.95 to 56.40) and 2 (95% CI 1.77 to 2.95), respectively. The percentage improvement from baseline of the CDLQI scores at week 12 was better in the etanercept group than the placebo group (52.3% versus 17.5%, respectively (P = 0.0001)). Analysis between the groups showed an e ect size that was clinically important (mean di erence 2.30, 95% CI 0.85 to 3.75; high-quality evidence). However, means, medians, and minimal important di erence results and results of the Pediatric Quality of Life Inventory, Stein Impact on Family Scale, and Harter Self-Perception Profile for Children scores must be interpreted with caution, as they were not prespecified outcomes. Three serious adverse events were reported, but they were resolved without sequelae. Deaths or other events such as malignant tumours, opportunistic infections, tuberculosis, or demyelination were not reported in the included study. Also, 13% of participants in the placebo group and 53% in the etanercept group had a PGA of clear or almost clear (risk ratio 3.96, 95% CI 2.36 to 6.66; high-quality evidence) at week 12. Authors' conclusions This review found only one RCT evaluating the use of this type of biological therapy. Although the risk of publication bias was high, as we included only one industry-sponsored RCT, the risk of allocation, selection, performance, attrition, and selective reporting biases for all outcomes (except for CDLQI) was low, and no short-term serious adverse events were found. We can conclude, based on this single included study, that etanercept seems to be e icacious and safe (at least in the short term) for the treatment of paediatric psoriasis. However, as the GRADE approach refers not to individual studies but to a body of evidence, we shall wait for the results of the ongoing studies in a future update of this review. In addition, future studies should evaluate quality-of-life endpoints established a priori and standardise primary outcome measures such as PASI 75, and should include the PGA as a secondary endpoint. Also, collating and reporting adverse events uniformly is required to better evaluate safety.

Biological treatments for paediatric psoriasis : a retrospective observational study on biological drug survival in daily practice in childhood psoriasis

“…19 The paucity of data on this topic was highlighted by a systematic Cochrane review up to July 2015 on the use of anti-TNFa agents in paediatric psoriasis, and the review found only one randomised controlled trial with a high risk of publication bias. 20 Of all the currently available biological agents, etanercept is the agent for which there are most data concerning its efficacy and safety in paediatric psoriasis. A double-blind, randomised, controlled trial conducted over 264 weeks comparing etanercept 0.8 mg/kg weekly with placebo in 211 patients aged 4-17 years with moderate-to-severe plaque psoriasis found significant superiority in favour of etanercept at weeks 12 and 96, (P < 0.001), with no significant adverse events.…”

“…Service de Dermatologie, Centre Hospitalier Universitaire de Brest, Brest, France 11 Service de Dermatologie, Centre Hospitalier Universitaire Pontchaillou, Universit e de Rennes, Rennes, France 12 Service de Dermatologie, V en er eologie et Canc erologie Cutan ee, Hôpital de la Timone, Assistance-publique-Hôpitaux de Marseille, Marseille, France 13 Service de P ediatrie, Hôpital Femme-M ere-Enfant, Hospices Civils de Lyon, Bron, France 14 Service de Dermatologie, Hôpital Archet 2, ESPIC CHU-Lenval, Nice, France 15 Service de P ediatrie G en erale, Hôpital Robert Debr e, Assistance Publique-Hôpitaux de Paris, Paris, France 16 Service de Dermatologie, Hôpital Sud, Amiens, France 17 Service de Rhumatologie P ediatrique, Hôpital Femme-M ere-Enfant, Hospices Civils de Lyon, Bron, France 18 Service de Dermatologie, Centre Hospitalier de Cornuaille, Quimper, France 19 Service de Dermatologie, Unit e de Dermatologie P ediatrique, Centre Hospitalier Universitaire de Tours, Universit e de Tours, Tours, France 20 Service de Rhumatologie P ediatrique, Centre Hospitalier Universitaire Bicêtre, Universit e Paris Sud-Saclay, UVSQ, Assistance Publique-Hôpitaux de Paris HP, Le Kremlin Bicêtre, France 21 Service de Dermatologie, Hôpital d'Instruction des Arm ees B egin, Saint Mand e, France 22 Service de Dermatologie, Hôpital de Niort, Niort, France 23 Service de Dermatologie, Centre Hospitalier Universitaire Charles-Nicolle, Rouen, France 24 Service de Dermatologie, Hôpital d'Auxerre, Auxerre, France 25 Service de Dermatologie, Centre Hospitalier Universitaire d'Angers, Angers, France 26 Service…”

Invasive fungal infections in pediatric patients treated with tumor necrosis alpha (TNF‐α) inhibitors

“…Apart from a dearth of meta-analyses and reviews on IFIs associated with the use of TNFα inhibitors among children and adolescents, 6 a considerable number of studies on pediatric patient populations receiving TNFα inhibitors reported no IFIs. [53][54][55][56][57][58][59][60][61][62][63][64][65] A larger study that included both adults and children that were treated with IFX in combination with other immunosuppressants and/ or steroids for CD showed an acceptable safety profile, although fungal infections were observed in 4% (n=21) of the patients following the first course of treatment. Age at first IFX dose, gender, disease duration and -extent were not associated with infectious adverse events.…”

Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation

“…(85,203) #21 (adolescen* or baby or babies or child or children or boy or boys or girl or girls or infant* or infanc* or juvenile* or paediatric or pediatric or preschooler* or schoolboy* or schoolgirl* or schoolchild* or teens or teenage* or toddler* or youth or youths or "young people" or "young person" or "young persons") (193,591) #22 #18 or #19 or #20 or #21 (193,591) #23 #17 and #22 (89) #24 #17 and #22 in Cochrane Reviews (Reviews and Protocols) (15) #25 #17 and #22 in Trials ( Records retrieved: 20.…”