Real-world data from a single Greek centre on the use of secukinumab in plaque psoriasis: effectiveness, safety, drug survival, and identification of patients that sustain optimal response.

BACKGROUND: Few studies have investigated the long-term outcomes of secukinumab in real-life psoriasis treatment where diverse patient profiles require a personalized approach. OBJECTIVES: To determine long-term performance of secukinumab in moderate-to-severe plaque psoriasis, and identify potential clinical factors predictive of sustained optimal response under real-world conditions. METHODS: In this 78-week, single-centre, retrospective study, effectiveness, safety and drug survival of secukinumab were evaluated. Effectiveness data are reported as observed. Co-primary endpoints were absolute Psoriasis Area and Severity Index (PASI) ≤3 at week 4, 16, 52, 78, and clinical predictors of PASI ≤3 and PASI100 responses at week 52 and 78. RESULTS: A total of 85 patients (75.3% male; mean age 48.6 years) were included. Absolute PASI ≤3 was achieved in 73% and 83% of patients at week 52 and 78, respectively. PASI 75/90/100 responses at week 52 (71.6%, 50.8%, and 40.3%, respectively) were sustained at week 78 (73.6%, 64.2%, and 45.3%, respectively). Median absolute PASI remained low at week 52/78 (0.9/0.6, respectively), while mean absolute PGA also sustained low (0-1) values after 16-78 weeks. Investigator's Global Assessment 0/1 response rate was maintained by week 52/78 (72/83%, respectively). The drug survival rate of secukinumab at week 78 was 79.1%. Treatment was discontinued in 17.9% of patients after an average of 41.7 weeks, mainly due to loss of effectiveness (10.4%). A total of 27% experienced adverse events, without critical safety concerns. Based on multivariate analysis, advanced body mass index (BMI) and presence of ≥3 comorbidities decreased the chance of achieving PASI ≤3 at week 78 [OR (95% CI) 0.78 (0.64-0.97); P = 0.024, and OR (95% CI) 0.045 (0.002-0.83); P = 0.037, respectively]. CONCLUSIONS: Secukinumab showed consistently high effectiveness in this real-life cohort, with an acceptable safety profile. Over time, persistence of PASI ≤3 response appears to be lower in patients with high BMI or multiple comorbidities.

Letter: Human papilloma virus and molluscum contagiosum lesions related to infliximab therapy for psoriasis: a case series.

INTRODUCTION: Biological therapy for psoriasis exerts its action via an immunomodulatory and eventually immunosuppressive mode. Immunosuppression is linked to HPV flares. Our purpose is to investigate a possible relationship between infliximab therapy for psoriasis and human papilloma virus and molluscum (HPV/MC) infections. METHODS: We report a case series of three patients with psoriasis on infliximab, who developed HPV/MC lesions following their treatment. RESULTS: Our patients developed HPV/MC lesions within a few months after the initiation of infliximab infusions for psoriasis. DISCUSSION: Immunosuppresion is related to HPV/MC flares. Biological therapy and in particular infliximab treatment acts by immunomodulation and eventually a degree of immunosuppression. CONCLUSIONS: Anti-TNF treatment could be associated with HPV and/or MC flares. For this reason, we suggest the consideration of obtaining a routine cervical PAP smear before the commencement and during treatment with anti-TNF agents for psoriasis.

Pimecrolimus 1% cream in non-specific inflammatory recurrent balanitis.

BACKGROUND: Non-specific balanitis is a common inflammatory dermatosis with frequent relapses and considerable impact on male sexual life. OBJECTIVE: To evaluate the efficacy and safety of pimecrolimus 1% cream in recurrent non-specific balanitis. METHODS: Twenty-six patients with recurrent flares of non-specific balanitis were randomly assigned to 1 group applying pimecrolimus cream 1% and 1 group applying placebo on the glans twice daily for 7 days. The patients were assessed on day 14. They were instructed to continue applying the agent whenever symptoms initialized for the following 90 days and take account of the cumulative days with symptoms. RESULTS: Seven out of the 11 (63.6%) patients in the pimecrolimus group and 1 out of 11 (9%) in the control group were free of all symptoms and lesions after 14 days, 3 (27.3%) in both groups reported improvement, while 1 (9.1%) in the pimecrolimus and 7 (63.6%) in the control group remained unaffected. (chi(2) = 9.0, d.f. = 2, p = 0.011). Days with symptoms during the 90-day follow-up period were 7.50 +/- 3.02 for the pimecrolimus and 17.62 +/- 4.40 for the control group (p = 0.000064). CONCLUSIONS: Pimecrolimus 1% cream is promising in relieving symptoms and signs of non-specific balanitis during flares and controlling the disease during long-term follow-up.

Oral inosiplex in the treatment of cervical condylomata acuminata: a randomised placebo-controlled trial.

Conventional therapies for human papillomavirus infection aim to remove clinically apparent lesions, while latent infection may remain, representing a threat for transmission and carcinogenesis. The use of a systemic agent may more effectively control the virus. We conducted a randomised placebo-controlled study to investigate the efficacy and safety of oral inociplex in the treatment of cervical condylomata acuminata (CA) that had been resistant to conventional therapies. Thirty-eight white European women, aged 20-43 years, with genital warts of the cervix, refractory to at least one conventional therapy, were randomly assigned to receive either inosiplex, 50 mg/kg daily peros for 12 weeks (group 1), or placebo (group 2). Of the 17 evaluable group 1 women, 4 responded to the treatment completely, 7 responded partially and 6 did not respond. Of the 19 group 2 women, none responded to the treatment completely, 3 responded partially and 16 did not respond. The therapeutic difference between women receiving active and placebo therapy was statistically significant (chi(2)= 6.69, P < 0.01) and remained significant when an intention-to-treat analysis was performed (chi(2)= 7.69, P < 0.01). None of the complete responders experienced recurrence during the 12-month follow up. Adverse effects were mild and resolved upon completion of therapy. Compared with placebo, inosiplex showed considerable efficacy with insignificant and reversible adverse effects and without recurrences. Inosiplex may represent an efficacious and safe alternative systemic form of therapy for cervical genital warts.