Consistent response to guselkumab treatment between Hispanic and non-Hispanic patients with psoriasis : an analysis from VOYAGE 1 and VOYAGE 2

Altres ajuts: Janssen Research and Development (JRD)Introduction: In VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244), guselkumab, an interleukin-23 blocker, was safe and effective in patients with moderate-to-severe plaque psoriasis. Methods: Patients who self-identified as Hispanic (n = 117) or non-Hispanic (n = 1686) were randomized to guselkumab, placebo, or adalimumab. Efficacy assessments included Psoriasis Area and Severity Index (PASI), Investigator's Global Assessment (IGA), and Dermatology Life Quality Index (DLQI). Results: At week 16, treatment differences for guselkumab versus placebo in the Hispanic and non-Hispanic populations were 67.4 (95% confidence interval 50.4, 84.4) and 77.2 (73.5, 80.8) percentage points for IGA 0/1 and 59.2 (41.9, 76.4) and 69.2 (65.7, 72.7) percentage points for PASI 90, respectively. Treatment differences for guselkumab versus adalimumab were 25.9 (6.5, 45.3) and 17.5 (12.8, 22.3) percentage points for IGA 0/1 and 21.4 (-0.1, 42.9) and 23.5 (18.2, 28.9) percentage points for PASI 90, respectively. Week 24 results were similar. Adverse event frequency was greater in adalimumab- versus guselkumab-treated patients in the Hispanic population only through weeks 16 and 28. In both populations, DLQI 0/1 responses were greater in guselkumab-treated versus placebo- and adalimumab-treated patients at week 16 and versus adalimumab-treated patients at week 24. Conclusions: Guselkumab safety and efficacy were consistent between Hispanic and non-Hispanic populations

Interventions for hidradenitis suppurativa: a Cochrane systematic review incorporating GRADE assessment of evidence quality

Background More than 50 interventions have been used to treat hidradenitis suppurativa (HS) and so therapy decisions can be challenging. Objectives To summarise and appraise randomised controlled trial (RCT) evidence for HS interventions in adults. Materials and methods Searches were conducted in MEDLINE, EMBASE, CENTRAL, LILACS, five trials registers and abstracts from eight dermatology conferences until 13 August 2015. Two review authors independently assessed study eligibility, extracted data and assessed methodological quality. Primary outcomes were quality of life and adverse effects of the interventions. Results Twelve trials, from 1983 to 2015, investigating 15 different interventions met our inclusion criteria. Median trial duration was 16 weeks and the median number of participants was 27. Adalimumab 40mg weekly improved the Dermatology Life Quality Index by 4.0 points, which equates to the minimal clinically important difference for the scale, compared to placebo (95% confidence interval (CI) -6.5 to -1.5 points). Evidence quality was reduced to ‘moderate’ because results are based on only a single study. Adalimumab 40mg every other week was ineffective in a meta-analysis of two studies comprising 124 participants. Infliximab 5mg/kg improved DLQI score by 8.4 points after eight weeks in a moderate quality study completed by 33 of 38 participants. Etanercept 50mg twice weekly was ineffective. Inclusion of a gentamicin sponge prior to primary closure did not improve outcomes. Other interventions including topical and oral antibiotics, were investigated by relatively small studies, preventing treatment recommendations due to imprecision. Conclusions More, larger RCTs are required to investigate most HS interventions, particularly oral treatments and surgical therapy. Moderate quality evidence suggests that adalimumab given weekly and infliximab are effective whereas adalimumab every other week is ineffective

Baseline Characteristics from UNITE: An Observational, International, Multicentre Registry to Evaluate Hidradenitis Suppurativa (Acne Inversa) in Clinical Practice

Background: Hidradenitis suppurativa (HS), also known as acne inversa, is a recurring, painful, chronic, and sometimes disfiguring inflammatory skin disease. Objectives: Our objective was to report the baseline clinical characteristics, natural history, and associated outcomes of patients with HS from the ongoing, prospective, non-interventional UNITE registry that is collecting data regarding the natural history and associated outcomes of HS. Methods: Patients with inflammatory HS lesions were enrolled, including adolescents (aged 12 to < 18 years) and adults (aged ≥ 18 years). None had participated in previous or current originator-adalimumab studies/registries. Patients received treatment consistent with site-specific, routine clinical practice. HS disease status was assessed by HS lesions and disease flare; treatment and outcomes data were collected at e

Critical appraisal of adalimumab in the treatment of chronic plaque psoriasis

Danielle Nicolazzo,1 Franz Kerdel,1 Francisco Kerdel1,2 1Florida Academic Dermatology Centers, The University of Miami Hospital, Miami, FL, USA; 2Florida International University, Miami, FL, USA Abstract: Psoriasis is a chronic inflammatory disease estimated to affect 1%&ndash;3% of the worldwide population. It is not simply a cutaneous disease but also poses a significant medical, social, and economic burden worldwide. Tumor necrosis factor (TNF)-&alpha; inhibitors are currently amongst the most important drugs in the therapeutic management of psoriasis. Patients using TNF-&alpha; inhibitors are at risk for infections including active and latent tuberculosis. Adalimumab, one of the TNF-&alpha; inhibitors, is a fully human monoclonal antibody that received approval for the treatment of chronic plaque psoriasis in 2008. Its use has been studied extensively for its safety and efficacy profile in the clinical setting. For the purpose of this review, we accessed the major publications in English relating to the use of adalimumab for psoriasis. Adalimumab appears to be one of the most efficacious biologic agents for the treatment of psoriasis. Results from various clinical trials including the REVEAL, CHAMPION, and BELIEVE are included in this review. The most recent data from an ongoing post-marketing study (ESPRIT) is also included in the analysis. Research regarding the safety, efficacy, and patient-reported outcomes support a favorable risk-benefit profile for adalimumab. Keywords: TNF-&alpha; inhibitor, safety, efficacy, outcome