Efficacy and safety of infliximab biosimilar Inflectra® in severe sarcoidosis

Schimmelpennink, Milou C.; Vorselaars, Adriane D.M.; Beek, Frouke T. van; Crommelin, Heleen A.; Deneer, Vera H.M.; Keijsers, Ruth G.; Veltkamp, Marcel

doi:10.1016/j.rmed.2018.02.009

Cited by 46 publications

(26 citation statements)

References 33 publications

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“…Adalimumab has also been used, although to a lesser extent [13,14]. Nowadays, biosimilars are commonly used and have proved to be effective and safe as well [15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Ranking Self-reported Gastrointestinal Side Effects of Pharmacotherapy in Sarcoidosis

Drent

Proesmans

Elfferich

et al. 2020

Lung

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Background Clinical manifestations of sarcoidosis vary widely, depending on the intensity of the inflammation and the organ systems affected. So far, no curative treatment exists; the disease can only be suppressed. All treatment options cause side effects affecting quality of life. The aim of this study was to establish and rank the prevalence of self-reported gastrointestinal side effects of drugs used in the treatment of sarcoidosis. Methods A cross-sectional web-based anonymous survey about complaints and side effects was conducted among sarcoidosis patients in the Netherlands, United Kingdom, and United States of America. Results Of the participants, 70% were being treated with one or more drugs. The most important reported side effect was weight gain, associated with increased appetite among prednisone users (as monotherapy as well as in combination with other drugs). Methotrexate (MTX) users especially experienced nausea, with monotherapy as well as combination therapy. Vomiting and weight loss were most prominent among azathioprine and mycophenolate mofetil (MMF) users, whereas diarrhoea was frequently mentioned by MMF and MTX users. The reported side effects of hydroxychloroquine were generally rather mild. Conclusion The current study ranked the gastrointestinal side effects associated with pharmacotherapy in sarcoidosis patients. Pharmacotherapy does have multiple gastrointestinal side effects. The strongest association between a reported side effect and drug use was that of weight gain associated with increased appetite among prednisone users. It would therefore be useful for future research to look further into dietary interventions to counter these side effects and reduce their burden.Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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“…Adalimumab has also been used, although to a lesser extent [13,14]. Nowadays, biosimilars are commonly used and have proved to be effective and safe as well [15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Ranking Self-reported Gastrointestinal Side Effects of Pharmacotherapy in Sarcoidosis

Drent

Proesmans

Elfferich

et al. 2020

Lung

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“…After 26 weeks of infliximab treatment, mean improvement in FVC was 6.6% predicted (p = 0.0007), whereas in the 6 months before treatment, lung function decreased. Maximum standardized uptake values (SUVmax) of the pulmonary parenchyma at baseline correlated significantly with FVC improvement during treatment (R = 0.62, p = 0.0004), which was confirmed in patients treated with an infliximab biosimilar [64].…”

Section: Pulmonary Function Tests and Fdg-positive Lung Parenchymal Dmentioning

confidence: 72%

In Which Patients with Sarcoidosis Is FDG PET/CT Indicated?

Keijsers

Grutters

2020

JCM

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Sarcoidosis is a granulomatous disease of which the etiology remains unknown. The diverse clinical manifestations may challenge clinicians, particularly when conventional markers are inconclusive. From various studies, it has become clear that fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT aids in sarcoidosis care. In this article, an update on FDG PET/CT in sarcoidosis is provided. The use of FDG PET/CT in the diagnostic process of sarcoidosis is explained, especially in determining treatable inflammatory lesions in symptomatic patients with indecisive conventional tests. Furthermore, FDG PET/CT for evaluating the potential benefit of additional inflammatory treatment is described and its use in cardiac sarcoidosis is highlighted.

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“…92 Schimmelpennink et al recently reported in a retrospective study of 29 patients that the IFX biosimilar (i.e., Inflectra ® ) appears to be effective in the treatment of refractory sarcoidosis with a profile comparable to the reference. 93 In contrast to randomized controlled trials versus placebo, in retrospective and open-labeled studies TNFi had more overall and serious adverse events and more severe infections. These adverse events seemed to be more frequent during sarcoidosis treatment than during other inflammatory diseases.…”

Section: Tnf-α Inhibitorsmentioning

confidence: 99%

<p>Refractory Sarcoidosis: A Review</p>

Jammal

Jamilloux

Gerfaud‐Valentin

et al. 2020

TCRM

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Sarcoidosis is a multi-system disease of unknown etiology characterized by granuloma formation in various organs (especially lung and mediastinohilar lymph nodes). In more than half of patients, the disease resolves spontaneously. When indicated, it usually responds to corticosteroids, the first-line treatment, but some patients may not respond or tolerate them. An absence of treatment response is rare and urges for verifying the absence of a diagnosis error, the good adherence of the treatment, the presence of active lesions susceptible to respond since fibrotic lesions are irreversible. That is when second-line treatments, immunosuppressants (methotrexate, leflunomide, azathioprine, mycophenolate mofetil, hydroxychloroquine), should be considered. Methotrexate is the only first-line immunosuppressant validated by a randomized controlled trial. Refractory sarcoidosis is not yet a well-defined condition, but it remains a real challenge for the physicians. Herein, we considered refractory sarcoidosis as a disease in which second-line treatments are not sufficient to achieve satisfying disease control or satisfying corticosteroids tapering. Tumor necrosis alpha inhibitors, third-line treatments, have been validated through randomized controlled trials. There are currently no guidelines or recommendations regarding refractory sarcoidosis. Moreover, criteria defining non-response to treatment need to be clearly specified. The delay to achieve response to organ involvement and drugs also should be defined. In the past ten years, the efficacy of several immunosuppressants beforehand used in other autoimmune or inflammatory diseases was reported in refractory cases series. Among them, anti-CD20 antibodies (rituximab), repository corticotrophin injection, and anti-JAK therapy anti-interleukin-6 receptor monoclonal antibody (tocilizumab) were the main reported. Unfortunately, no clinical trial is available to validate their use in the case of sarcoidosis. Currently, other immunosuppressants such as JAK inhibitors are on trial to assess their efficacy in sarcoidosis. In this review, we propose to summarize the state of the art regarding the use of immunosuppressants and their management in the case of refractory or multidrugresistant sarcoidosis.

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Efficacy and safety of infliximab biosimilar Inflectra® in severe sarcoidosis

Abstract: Infliximab biosimilar Inflectra seems effective in the treatment of refractory sarcoidosis with a comparable safety profile to the reference product Remicade. Inflectra can be considered as an alternative and less expensive option for patients with refractory sarcoidosis.

Cited by 46 publications

References 33 publications

Ranking Self-reported Gastrointestinal Side Effects of Pharmacotherapy in Sarcoidosis

Ranking Self-reported Gastrointestinal Side Effects of Pharmacotherapy in Sarcoidosis

In Which Patients with Sarcoidosis Is FDG PET/CT Indicated?

<p>Refractory Sarcoidosis: A Review</p>

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