Treatment Patterns and Pharmacoutilization in Patients Affected by Psoriasis: An Observational Study in an Italian Real-World Setting.

BACKGROUND: Real-world data can inform the use of biologics for psoriasis (PSO). OBJECTIVE: The aim was to evaluate treatment patterns and analyze pharmacoutilization in PSO patients in a real-world Italian setting, with a focus on the biologics most recently introduced. METHODS: An observational study based on administrative databases was conducted. Patients were included based on PSO diagnosis identified by either discharge diagnosis or exemption code or prescription of anti-psoriatic topical drugs (proxy of diagnosis). To describe patient characteristics and treatment patterns using the most up-to-date data, two different approaches were used: a cross-sectional study performed during 2016-2018, and a longitudinal study conducted with patients who received their first biological/targeted synthetic drugs (naïve patients) in 2014 and 2017 (the inclusion periods). RESULTS: During 2016-2018, the number of prevalent patients diagnosed with PSO was 194,054 (2016), 210,830 (2017), and 225,171 (2018). The percentage of patients receiving biologics or targeted synthetic agents ranged from 1.5 to 2.1%. Among them, naïve patients receiving interleukin (IL) inhibitors increased from 37.5% (2016) to 69.4% (2018), while those receiving anti-tumor necrosis factor (anti-TNF) decreased from 62.5% (2016) to 30.6% (2018). The longitudinal analysis included 894 and 1218 naïve patients in 2014 and 2017, respectively, of whom 7.2% (2014) and 6.9% (2017) switched therapy after a mean of 7.1 (2014) and 6.9 (2017) months. Overall, 259 patients were prescribed ixekizumab starting in 2017, of whom 73% were naïve. Ixekizumab was prescribed as monotherapy to 52.5%. CONCLUSIONS: The proportion of patients receiving biologics appeared constant over the years, with an increasing number of naïve patients being prescribed IL-17 inhibitors. Ixekizumab patients were mostly naïve.

Number needed to treat for interleukin inhibitors approved for the treatment of moderate-to-severe plaque psoriasis in Italy.

Background: Interleukin (IL) inhibitors achieve greater levels of efficacy than older systemic therapies. We calculated the number needed to treat (NNT) of ixekizumab compared with other IL inhibitors approved in Italy for the treatment of moderate-to-severe plaque psoriasis. Methods: The clinical efficacy was evaluated in terms of NNT, based on the results of a recent network meta--analysis (NMA) by the Cochrane Database of Systematic Reviews. The NMA investigated many systemic and biological treatments, but this analysis compared only the efficacy of the following IL inhibitors - brodalumab, guselkumab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab - for patients with moderate-to-severe plaque psoriasis. Drugs were compared and ranked according to effectiveness considering the PASI (Psoriasis Area and Severity Index) 90 score. Results: One-hundred and forty trials (51,749 patients) were included in the NMA. Considering the proportion of patients who achieve PASI90, ixekizumab showed the lowest NNT among all comparators (ixekizumab 2.01 [2.46-3.00]; risankizumab 2.05 [2.50-3-05]; guselkumab 2.16 [2.68-3.36]; secukinumab 2.40 [2.90-3.51]; brodalumab 2.61 [3.18-3.88]; ustekinumab 3.44 [4.12-4.95]; tildrakizumab 3.10 [4.15-5.59]. Conclusion: The findings show that ixekizumab is the most effective option (NNT) for the treatment of moderate-to-severe plaque psoriasis.

Clinical predictors of nonresponse to anti-TNF-α agents in psoriatic patients: A retrospective study.

Although the heterogeneity of the therapeutic response to TNF-α blockers seems to be mainly due to genetic factors, several studies showed that a range of factors may influence it. The aim of our study was to investigate the impact of patients' demographic and clinical characteristics on primary response to an anti-TNF-α therapy in psoriatic patients. We retrospectively examined the relationship between various clinical and demographic features and response to treatment with etanercept, adalimumab, and infliximab, evaluated as PASI75 and average PASI improvement at weeks 12, 16, and 14, respectively. We analyzed data obtained from 199 patients. A better response to the treatment was significantly associated with male gender (OR = 2.59), coexistence of psoriatic arthritis (OR = 1.97), and PASI ≤15 at baseline (OR = 0.91). The present study supports that some clinical factors may be potential predictors of response to anti-TNF-α agents in psoriatic patients.

Melanoma and non-melanoma skin cancer in psoriatic patients treated with high-dose phototherapy.

OBJECTIVES: The carcinogenic effect of plus ultraviolet A (PUVA)-therapy in psoriatic patients has been widely demonstrated, while data on the safety of narrow band (311 nm) ultraviolet B (nb-UVB) are scarce. We investigated the occurrence of melanoma and non-melanoma skin cancer (NMSC) in psoriatic patients treated with nb-UVB or PUVA-therapy. METHODS: This retrospective study included patients affected by psoriasis, who had been treated with nb-UVB or PUVA-therapy. Clinical data and phenotypic risk factors were collected and a total body examination was performed at a routine appointment during the study period. RESULTS: We examined 92 patients (60 males and 32 females; mean age: 53.5 years, range: 20-83 years) treated with PUVA-therapy (42/92, 45%) or with nb-UVB (50/92, 55%) for 1-28 years (mean: 7.1 years). Among patients treated with PUVA, nine skin tumors (one melanoma, seven basal cell carcinoma (BCCs) and one squamous cell carcinoma (SCC)) were detected in 2/42 (4.7%) patients, while in the nb-UVB group, 14 skin tumors including two melanomas, four BCCs, and eight SCCs were diagnosed in 6/50 (12%) patients. CONCLUSIONS: A noteworthy number of NMSC were diagnosed in this Mediterranean population of patients exposed to high-dose UV treatment. A thorough risk-benefit evaluation should always be done before UV treatment and patients should be carefully monitored for skin cancer during and after treatment discontinuation.

Management of recurrent cutaneous abscesses during therapy with infliximab.

BACKGROUND: Infliximab is a chimeric monoclonal antibody, belonging to the class of anti-tumor necrosis factor-α (TNF-α) agents, approved for the treatment of psoriasis and psoriatic arthritis. Drugs of this class are known to be associated with an infective risk, probably because they interfere with inflammatory and immune response at different levels. Although cutaneous Staphylococcus aureus infections seem to be more frequent than any other infection in the course of anti-TNF-α treatment, only a few case reports in the literature deal with this side effect, and, in particular, with its management. OBJECTIVE: Our aim was to report a case of recurrent methicillin-sensitive S aureus (MSSA) cutaneous abscesses during therapy with infliximab and successful management. CASE SUMMARY: In July 2009, a 53-year-old white woman (weighing 85 kg) affected by psoriasis and psoriatic arthritis was administered infliximab (5 mg/kg IV), based upon clinical appearance and previous unsuccessful treatment with cyclosporine, methotrexate, etanercept, and adalimumab. Three days after the first 3 infusions (at weeks 0, 2, and 6) she complained about the recurrent onset of painful, erythematous, indurated, and pus-draining cutaneous nodules located on her abdomen. The swab always revealed the presence of MSSA, and antibiotic oral therapy with amoxicillin + clavulanic acid (875 + 125 mg BID for 7 days) was established, with complete resolution of the abscesses. Routine laboratory findings were in normal ranges, with the exception of an elevated erythrosedimentation rate and an increased white blood cell count (range, 13,000-15,000/mm(3)) with neutrophilia (range, 75%-80%). HIV infection was ruled out. In agreement with the infectious disease consultant, 1 day before the fourth infusion, a prophylactic antibiotic therapy with amoxicillin + clavulanic acid (875 + 125 mg BID for 5 days) was added to the therapeutic regimen. This treatment schedule was successfully repeated at each following infusion (every 8 weeks), and no recurrence of skin abscesses was observed. The patient provided signed authorization for publication of this case. CONCLUSIONS: This case report describes a woman with psoriasis and psoriatic arthritis who developed MSSA skin abscesses after each of the first 3 infliximab infusions, which did not recur for the next 6 infusions after amoxicillin + clavulanic acid was added to her regimen, pre- and 4 days postinfusion. Adequately designed, placebo-controlled, double-blind trials are needed to determine whether such prophylactic antibiotic treatment is well tolerated or effective for this common complication of therapy with anti-TNF-α agents, when withdrawal of the drug is not advisable, as in this case.