Safety profiles of biologic agents for inflammatory bowel diseases: a prospective pharmacovigilance study in Southern Italy

Roberti, Roberta; Iannone, Luigi Francesco; Palleria, Caterina; Sarro, Caterina De; Spagnuolo, Rocco; Vero, Anna; Manti, Antonia; Pisana, V; Fries, Walter; Trifirò, Gianluca; Naturale, Maria Diana; Larussa, Tiziana; Francesco, Adele Emanuela De; Bosco, Vincenzo; Paola, Eugenio Donato Di; Citraro, Rita; Luzza, Francesco; Bennardo, Luigi; Rodinò, Stefano; Doldo, Patrizia; Spina, Edoardo; Russo, Emilio; Sarro, Giovambattista De

doi:10.1080/03007995.2020.1786681

Cited by 43 publications

(36 citation statements)

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“…70.2% vs. bDMARD: 17.5%) and 12.3% were type B (sDMARD: 8.1% vs. bDMARD: 4.2%); no other ADR types were observed [25]. In addition, according to severity, 22.6% of the reports were classified as serious, consistent with what was found in Italy (9.8-25.5%) [15,23], Japan (18.5-23.4%) [20,26], Spain (21.7%) [19], Brazil (25.0%) [22] and Korea (32.3%) [12]. Among severe reactions, the possibility of developing cancer, infections, hypersensitivity reactions and major cardiovascular events is described in the literature [10,12,14,19,22], and fatalities can also occur, which in this report corresponded to 0.1% of all ADRs, a rate lower than that documented in another study [27].…”

Section: Discussionsupporting

confidence: 84%

“…The ADRs most documented in different studies are those related to infections [14,15,[19][20][21], general manifestations or those associated with the administration of biotech drugs [12,22,23] and those related to the skin or subcutaneous tissues [4,12,23,24]. However, the present study found that the most common ADRs were those related to the respiratory tract, diverging with what was found in other studies where their frequency was much lower (16.8 vs. 3.8-10.8%) [4,12,24], probably because we included in this category infections such as pneumonia and bronchitis, among others, which increased the proportion of respiratory tract-related ADRs.…”

Section: Discussionmentioning

confidence: 99%

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Adverse drug reactions associated with the use of biological agents

Machado‐Alba

Jiménez-Morales

Moran-Yela

et al. 2020

Preprint

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IntroductionBiotech drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with serious adverse drug reactions (ADRs).ObjectiveTo identify the ADRs associated with the use of biotech drugs in Colombia.MethodsThis was a retrospective study of ADR reports from 2014 to 2019, contained in the database of the pharmacovigilance program of Audifarma SA. The ADRs, groups of associated drugs, and affected organs were classified.ResultsA total of 5,415 reports of ADRs associated with biotech drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most commonly affected organ system (16.8%), followed by the skin and adnexa (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%).ConclusionsThere has been an incremental increase in the reporting of ADRs associated with the use of biotech drugs in the pharmacovigilance program, related to the strengthening and appropriation of the patient safety culture and improvement in the quality of the generated information. It is important to empower physicians and entire health teams to ensure the traceability of ADRs and to perform interdisciplinary interventions derived from pharmacovigilance at the individual and population levels.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Adverse drug reactions associated with the use of biological agents

Machado‐Alba

Jiménez-Morales

Moran-Yela

et al. 2020

Preprint

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“…Regarding the ratio of AEs reports related to biologic treatments in our region, a considerable improvement has been achieved in the last four years due to active pharmacovigilance programs, as demonstrated in our previous study in rheumatology [ 9 ] and gastroenterology [ 13 ] and generally such as reported in literature [ 25 , 26 ]. In this study, the number of AEs reported seems to be considerably increased (from 7 to 87) compared to the previous two years in the same centres, although the overall number of patients treated subdivided per drug are mandatory to assess confounding variables and confirm improvement.…”

Section: Discussionmentioning

confidence: 65%

“…The Calabria Biologics Pharmacovigilance Program (CBPP) is a multicentre pharmacovigilance study as previously described [ 9 , 13 ]. Briefly, CBPP is a multicenter pharmacovigilance study aimed at improving the continuous monitoring of safety of treatment with biologic drugs in clinical practice.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2020

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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.

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“…Dear Editor, We read with interest the article by Roberti et al, 1 who evaluated adverse effects (AEs) of biologic agents in 623 patients with inflammatory bowel disease (IBD) over a two-year period. They identified AEs in 14.8% of patients, including serious AEs (SAEs) in 1.6%, most commonly skin and subcutaneous disorders and infusion reactions.…”

Section: Letter To the Editormentioning

confidence: 99%