A Six-Year Analysis of Biological Therapy for Severe Psoriasis in a Lithuanian Reference Centre of Dermatovenereology

Abstract

Background and Objectives: Biological therapy is widely used for the treatment of severe psoriasis. The objective of this study was to evaluate the efficacy and safety of biological therapy for patients with severe psoriasis. Materials and Methods: A retrospective study of 79 patients with severe psoriasis, who have been treated with biological therapy between 2012 and 2018, was conducted. During this study, the following data were collected and evaluated: sex, age, body mass index (BMI), duration of illness, the results of treatment with biological therapy, concomitant therapy, Psoriasis Area and Severity Index (PASI) and adverse events. Results: In total, 74.7% (n = 59) of subjects were male. Their overall average age was 47.4 ± 11.4 (range: 18–73) years. Their baseline BMI was 27.6 ± 5.9, which increased to 29.6 ± 4.5 after 6 years of treatment. The mean duration of psoriasis was 25.7 ± 12.5 years. In total, 39.2% (n = 31) of subjects received infliximab, 36.7% (n = 29)—etanercept, 24.1% (n = 19)—ustekinumab. The treatment duration for infliximab, etanercept and ustekinumab was 201.6 ± 86.8, 156.2 ± 137.4 and 219.1 ± 95.7 weeks (p < 0.01), respectively. Overall, 65.8% (n = 52) of subjects were also on methotrexate; 30.8% (n = 16) of them discontinued it due to clinical improvement (31.3% (n = 5)), impaired liver function (31.3% (n = 5)), and intolerance (25% (n = 4)). Baseline PASI was 20.8 ± 8.8. PASI 50 was achieved by 96.2% (n = 76) of patients at week 11, PASI 75 by 86.1% (n = 68) at week 16, PASI 90 by 54.4% (n = 43) at week 35, and PASI 100 by 13.9% (n = 11) at week 33. The overall incidence rate of adverse events was 0.362 per patient year of follow-up. Conclusion: Biological therapy is an effective and safe treatment for patients with severe psoriasis.

Effectiveness and Safety of Biological Therapies in Very Severe Plaque Psoriasis: A Real-Life Retrospective Study

“…Extensive real-world evidence indicates that higher psoriasis severity is linked to lower HRQoL and increased impairments in work productivity [9,10]. This is also explained by the higher prevalence of comorbidities compared to the general population; severe psoriasis is associated with a significant increased risk of myocardial infarction, coronary artery disease, stroke, and cardiovascular mortality, as well as metabolic syndrome, type 2 diabetes mellitus, inflammatory bowel diseases, depression, anxiety, and suicidal ideation [2][3][4][5][6][7].…”

“…Although, in most cases, the disease manifests on the skin, it is also associated with important comorbidities, including psoriatic arthritis, metabolic syndrome, cardiovascular diseases, inflammatory bowel diseases, type 2 diabetes mellitus, depression, and cancer [2,[4][5][6][7]. The Psoriasis Area and Severity Index (PASI) is a tool used to evaluate and categorize the severity of psoriatic lesions and their response to treatment; it divides the body into four regions, the head, trunk, upper extremities, and lower extremities, and each of these areas is individually examined to determine the percentage of involvement, resulting in a numerical score ranging from 0 (no involvement) to 6 (90% to 100% involvement).…”

“…Additionally, parameters such as erythema, induration, and scaling are assessed on a scale from 0 to 4. The PASI generates a numerical score ranging from 0 (no psoriasis) to 72; a score below 10 defines psoriasis as mild, 10 to 15 as moderate, and above 15 as severe [4,8]. With itching, pain, and scaling as its key symptoms, psoriasis can have an important impact on patient's health-related quality of life (HRQoL) and work productivity, with growing real-world evidence showing an association of higher impairments with greater disease severity [9,10].…”

“…While mild forms can be managed by topical therapy, moderate-to-severe psoriasis typically requires systemic therapy. However, various barriers may block the initiation of systemic drugs, mainly due to the safety concerns shared by both patients and clinicians [4,12]. These concerns are justified, considering that traditional oral systemic therapies like methotrexate, cyclosporine, and acitretin come with potential organ toxicities, tolerability issues, and the need for regular laboratory monitoring [12,13].…”

“…Biologics are monoclonal antibodies targeting cytokines such as interleukin(IL)-17, IL-23, IL-12/23, and tumor necrosis factor-alpha (TNF-α); due to their great efficacy and tolerance, they are increasingly used for treating moderate-to-severe psoriasis when the patient does not tolerate the traditional systemic therapies due to adverse effects or inefficacy [4,13]. The great efficacy of biologics drives higher expectations and goals in the management of moderate-to-severe psoriasis; a ≥90% improvement in PASI (PASI90) or the achievement of absolute PASI ≤ 2 until 16 weeks of treatment are the current aims of treatment [2,15].…”