Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study

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.

IL‐17A inhibitors in patients with chronic plaque psoriasis and history of malignancy: A case series with systematic literature review

“…The use of IL‐17A inhibitors has not been associated with risk of developing de novo malignancy in controlled clinical trials or registries 14‐16 . Pharmacovigilance studies did not report an higher incidence of malignancy in patients with psoriasis treated with IL‐17A inhibitors 17,18 . Conversely, there is increasing evidence that IL‐17 inhibition may play a favorable and/or protective role against malignancy 19 .…”

“…inhibitors. 17,18 Conversely, there is increasing evidence that IL-17 inhibition may play a favorable and/or protective role against malignancy. 19 to the therapeutic failure.…”

Adverse Drug Reaction Reporting by Patients in 12 European Countries

“…Important data has shown in several studies that the active pharmacovigilance approach implemented in healthcare can significantly increase the number of ADRs [ 22 , 23 ]. Active calls to patients or reminder messages help to draw consumers’ attention to possible ADRs that might be mistakenly assigned to illness instead of the medicine in use [ 23 , 24 ].…”

The Interplay between Immune System and Microbiota in Inflammatory Bowel Disease: A Narrative Review

“…In addition, IBD patients often receive multiple treatments and the response to treatment is highly variable depending on the subject, demonstrating the need for a deeper understanding of the disease as well as innovative therapeutics approaches. Growing insights into immunomediated diseases pathophysiology, such as IBD, have led to the advent of targeted therapies, which could selectively interfere with crucial mediators of the inflammatory process [ 2 , 3 , 4 , 5 ].…”