Patient reports of the frequency and severity of adverse reactions associated with biological agents prescribed for psoriasis in Brazil

Lopes, Luciane Cruz; Silveira, Miriam Sanches do Nascimento; Camargo, Mayara Costa de; Camargo, Iara Alves de; Luz, Tatiana Chama Borges; Osório-de-Castro, Claudia Garcia Serpa; Barberato‐Filho, Silvio; Fiol, Fernando de Sá Del; Guyatt, Gordon

doi:10.1517/14740338.2014.942219

Cited by 10 publications

(10 citation statements)

References 38 publications

(38 reference statements)

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“…In Brazil, ANVISA made the decision to suspend marketing in the same year. Before efalizumab was removed from the Brazilian market, a biological drug safety study had reported that 44.2% of patients receiving this drug discontinued the treatment due to serious adverse reactions …”

Section: Discussionmentioning

confidence: 99%

“…Before efalizumab was removed from the Brazilian market, a biological drug safety study had reported that 44.2% of patients receiving this drug discontinued the treatment due to serious adverse reactions. 39 The research and development of new biological medicines are a growing trend. 10 As in other countries, biologicals accounted for a quarter of the new drugs registered in Brazil between 2003 and 2013 and gave rise to more than 30% of PMSEs.…”

Section: Discussionmentioning

confidence: 99%

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Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study

Botelho

Martins

Vieira

et al. 2016

The Journal of Clinical Pharma

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This study investigated postmarketing safety events (PMSEs) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSEs were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) by the US Food and Drug Administration (FDA) and Brazil were recorded. A Kaplan-Meier survival curve of the period between the date of ANVISA registration and the PMSE was calculated. We found a statistically significant difference between the time to PMSE for drugs with an FDA REMS compared with those without a REMS, with a log rank value (Mantel Cox) of 0.002. There was no association between the time to PMSE and the other drug characteristics investigated. This study demonstrated that the frequency of PMSEs for new drugs approved by ANVISA was statistically associated with the existence of an FDA REMS. The time between approval and first PMSE was shorter for drugs with an FDA REMS, and this finding may contribute to improved awareness of the risk/benefit balance required to ensure continued safe and effective use of new drugs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study

Botelho

Martins

Vieira

et al. 2016

The Journal of Clinical Pharma

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“…The safety profiles of IFX treatment in patients with rheumatic diseases has been verified by registries in many countries . However, only a few studies including several hundreds of psoriasis patients reported about the safety and efficacy of IFX treatment in real‐world clinical practice …”

Section: Discussionmentioning

confidence: 99%

“…21 However, only a few studies including several hundreds of psoriasis patients reported about the safety and efficacy of IFX treatment in real-world clinical practice. [22][23][24][25][26][27] In addition, the safety and efficacy profiles of IFX in realworld clinical practice for treating Japanese psoriasis patients remain unclear, because a clinical trial on the safety and efficacy of IFX involved only 114 psoriasis patients. 14,15 We conducted a large-scale, prospective PMS to evaluate the safety and efficacy of IFX treatment, which enrolled all patients treated with IFX, and this study clarified the safety profiles and efficacy of IFX treatment in Japanese psoriasis patients.…”

Section: Discussionmentioning

confidence: 99%

Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post‐marketing surveillance

Torii

Terada

Matsukawa³

et al. 2015

The Journal of Dermatology

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A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma.

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“…New technologies are registered based on controlled and randomized clinical trials, in which, in most cases, they fail to capture important safety results that only appear in real-life studies ( Lopes et al., 2014 ; Fulone et al., 2018 ; De Carmago et al., 2019 ). In addition, in the case of new cancer medicines, often licensed on the basis of limited information, which can cause concern and wasted resources ( Pontes et al., 2020 ).…”

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confidence: 99%

Editorial: New Horizons in Health-Promoting Technologies: From Development to Rational Use

et al. 2020

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Patient reports of the frequency and severity of adverse reactions associated with biological agents prescribed for psoriasis in Brazil

Abstract: Biologic agents were associated with high rates of ADRs and SAEs. The data suggests that for patients taking a biologic agent to treat psoriasis and who have one or more comorbidities, warnings of possible adverse events and enhanced surveillance are warranted.

Cited by 10 publications

References 38 publications

Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study

Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study

Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post‐marketing surveillance

Editorial: New Horizons in Health-Promoting Technologies: From Development to Rational Use

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