Abstract
Psoriasis is an inflammatory and chronic skin disorder associated with physical and psychological burden impairing patients’ quality of life. In the last decade, biologic drugs have widely changed treatment of moderate-severe psoriasis and their number is increasing overtime. To early identify expected/unexpected adverse events (AEs) with biologic treatments, pharmacovigilance programs are needed. We designed a post-marketing active pharmacovigilance program to monitor and analyse AEs and/or serious adverse events (SAEs) reports. All consecutive patients treated with one biologic drug during a two-years period and satisfying inclusion criteria have been enrolled in five Dermatology tertiary units. Demographic and clinical features of patients, type of treatment used, therapy discontinuation, failures, switch/swap to another biologic, and possible onset of AEs were collected. Overall, 512 patients with a diagnosis of psoriasis (286; 55.9%) or arthropathic psoriasis (226; 44.1%) have been enrolled. Eighty-two (16%) patients with AEs and 5 (1%) with SAEs have been identified. Further, 59 (11.5%) had a primary/secondary failure (mainly on infliximab and etanercept). The adverse events and SAEs were reported with golimumab (4/12), adalimumab (32/167), infliximab (9/48), etanercept (31/175) and ustekinumab (11/73), no adverse events have occurred with secukinumab (0/37). Infliximab and etanercept were significantly associated with primary/secondary failures, whereas no differences have been highlighted for AEs insurgence. On the other hand, ustekinumab seems to be associated with a low rate of AEs (p = 0.01) and no adverse events or failures have been reported with secukinumab (p = 0.04 and 0.03, respectively). Our study, even though limited by a small sample size and a brief follow-up period, provide useful data on widely used biologic drugs and their tolerability, discontinuation rate and the incurrence of severe adverse events. Further studies are necessary to include the recently approved biologic drugs and to increase the sample size for more detailed analysis.
Highlights
In Europe, for moderate to severe psoriasis, systemic drugs are the treatments of choice subdivided in a first line of conventional drugs and a second line of biologic drugs approved for psoriasis and psoriatic arthritis (TNF-α inhibitors [infliximab, etanercept, adalimumab], IL-12 and 23 blockers [ustekinumab and guselkumab] and anti-IL17 [secukinumab, ixekizumab and brodalumab]) or for arthropathic psoriasis [4]
Biologic drugs can be associated to adverse events (AEs) not related to their specific mechanism of action but by triggering unwanted immune response, with anti-drugs antibodies production [7]
N (%) Psoriatic arthritis, n (%) Concurrent treatments MTX, n (%) CyA, n (%) Acitetrin, n (%) CCS, n (%) NSAIDs, n (%) Psoralen Ultra-Violet A (PUVA), n (%) Apremilast, n (%) Switched, n (%) Adverse events AEs, n (%) serious adverse events (SAEs), n (%) AEs onset after treatment initiation, months1
Summary
Psoriasis is an inflammatory and chronic skin disorder affecting about 3% of the population worldwide, associated with physical and psychological burden impairing patients’ quality of life [1].Compared to general population, several chronic diseases have a higher incidence in patients with psoriasis such as psoriatic arthritis (10–30% prevalence), cardiovascular disorders, Crohn’s disease and depression, increasing both morbidity and mortality [2,3].Nowadays, according to evidence-based guidelines [4,5], treatments for psoriasis include topical therapy, phototherapy, conventional and biological systemic treatments.In Europe, for moderate to severe psoriasis, systemic drugs are the treatments of choice subdivided in a first line of conventional drugs (methotrexate, cyclosporine A and retinoids) and a second line of biologic drugs approved for psoriasis and psoriatic arthritis (TNF-α inhibitors [infliximab, etanercept, adalimumab], IL-12 and 23 blockers [ustekinumab and guselkumab] and anti-IL17 [secukinumab, ixekizumab and brodalumab]) or for arthropathic psoriasis (golimumab, a TNF-α inhibitor) [4].Over the past 15 years, biologic therapies have revolutionized the treatment of moderatesevere psoriasis with substantial improvements in patients’ management. Nowadays, according to evidence-based guidelines [4,5], treatments for psoriasis include topical therapy, phototherapy, conventional and biological systemic treatments. In Europe, for moderate to severe psoriasis, systemic drugs are the treatments of choice subdivided in a first line of conventional drugs (methotrexate, cyclosporine A and retinoids) and a second line of biologic drugs approved for psoriasis and psoriatic arthritis (TNF-α inhibitors [infliximab, etanercept, adalimumab], IL-12 and 23 blockers [ustekinumab and guselkumab] and anti-IL17 [secukinumab, ixekizumab and brodalumab]) or for arthropathic psoriasis (golimumab, a TNF-α inhibitor) [4]. Biologic drugs have several advantages compared to conventional treatment including no evidence of cumulative toxicity or clinical-relevant drug-drug interactions, established long-term efficacy and warranted use in renal or hepatic impaired patients [6]. Biologic drugs can be associated to adverse events (AEs) not related to their specific mechanism of action but by triggering unwanted immune response, with anti-drugs antibodies production [7]
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