Effectiveness of guselkumab in patients with facial and/or genital psoriasis: Interim analysis results at Week 12 from the GULLIVER study.

BACKGROUND: Facial (FP) and genital psoriasis (GP) significantly affect patients' quality of life. Despite the advances in treatments, limited data on efficacy and safety are available on these difficult-to-treat areas. Guselkumab is an interleukin (IL)-23 inhibitor which has been proven effective in treating patients with moderate-to-severe plaque psoriasis. OBJECTIVES: The aim of this interim analysis was to report the efficacy and safety of guselkumab in the treatment of patients with FP and/or GP. MATERIALS AND METHODS: GULLIVER is a 52-week Italian observational study to evaluate the effectiveness and safety of guselkumab in a real-life setting in patients with FP and/or GP. Adult patients with facial and/or genital moderate-to-severe psoriasis (sPGA score ≥ 3) were included. The primary endpoint of this analysis was the percentage of patients achieving a facial or genital sPGA score of 0 (clear) or 1 (almost clear), at Week 12. The change in the score of the facial or genital sPGA components in patients with a score ≥3 for each sPGA component was assessed. PASI score in patients with a baseline PASI above or below 10 was evaluated. RESULTS: Overall, 351 patients were included in the study; 83.3% of FP and 76.5% of GP patients achieved the primary endpoint. Similar response rates were observed for the facial or genital sPGA components in patients with a baseline facial or genital sPGA score ≥3 in each component. Among patients with a baseline PASI score >10, mean PASI score improved from 19.0 (SD 8.3) to 2.2 (SD 4.8). Forty-four AEs were observed in 32 patients; two mild and transient AEs (fatigue and nausea) were considered treatment related. No SAEs were observed. CONCLUSIONS: Guselkumab, showing to be effective and safe in treating FP and GP, may be a valid therapeutic option for patients with psoriasis localized in these difficult-to-treat areas.

Safety evaluation of apremilast for the treatment of psoriasis.

INTRODUCTION: Psoriasis (PSo) is a chronic inflammatory skin disease associated with co-morbidities such as hypertension, diabetes, dyslipidemia and metabolic syndrome. It is a typothypical Th1/Th17 disease that affects from 2 to 3% of the world population. Numerous are the drugs that can be used in our clinical practice; the choice of these drugs depends on the characteristics of the patient. Areas covered: Apremilast is the first oral small molecules to receive FDA approval for the treatment of adults with active psoriasis and psoriatic arthritis. It is a small-molecule that specifically inhibits the activity of cyclic AMP phosphodiesterase-4 (PDE4). Several analyses have been performed on data from phase III studies to assess apremilast safety and efficacy on psoriasis and psoriatic arthritis (PsA). Apremilast could also represent a treatment opportunity for those patients unresponsive to both systemic and biological agents or whose treatment was contraindicated. Expert opinion: For its safety profile and easy route of administration, apremilast may offer an oral treatment option for those patients that discontinue treatments because of ineffectiveness, intolerability or ineligibility to the currently available drugs.

Topical lactoferrin can improve stable psoriatic plaque.

AIM: Lactoferrin (LF), a non-haem iron binding glycoprotein, shares antimicrobial properties with innate immune system components influencing proinflammatory release of cytokines involved in psoriatic plaque development. The objective of the study was to verify if LF could provide a therapeutic application in psoriasis. METHODS: An open-label, two arms, 4-week trial was designed on 30 subjects affected by mild to moderate plaque psoriasis. All patients received oral bovine LF 100 mg. Fifteen patients (group A) were topically treated with 10% LF ointment, 15 patients (group B) with 20% LF ointment. All patients applied only ointment vehicle on contra lateral target lesion as intra-patient side to side control. Efficacy was assessed by Target Lesion Score. RESULTS: Twenty-two patients completed the study. Improvement in elevation, redness and scaling was observed on LF treated psoriatic target lesions comparing to the controlateral controls (P<0.05). There was no additional efficacy for 20% versus 10% topical applications. Oral drug alone did not exert any improvement on the control plaques receiving topical placebo. CONCLUSION: Our clinical results suggest that LF could be included as a possible safe topical therapeutic option in the treatment of psoriatic plaque.