Inflammatory Bowel Disease and Sleep Disturbance: As Usual, Quality Matters

Barberio, Brigida; Zingone, Fabiana; Savarino, Edoardo

doi:10.1007/s10620-020-06268-5

Cited by 15 publications

(13 citation statements)

References 9 publications

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“…Inflammatory Bowel Diseases (IBDs), including ulcerative colitis (UC) and Crohn's Disease (CD), are chronic inflammatory disorders which are characterized by intermittent periods of remission and relapses 1,2 , and can greatly affect quality of life (QoL) of patients [3][4][5] . Prognosis dramatically changed after the introduction of biological agents, including anti-Tumor Necrosis Factor-alpha (TNF-α) 6 , which can control flares, prevent complications…”

Section: Aesmentioning

confidence: 99%

Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator

Cingolani

Barberio

Zingone

et al. 2021

Sci Rep

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To date, data on effectiveness and safety of Adalimumab (ADA) biosimilars in inflammatory bowel diseases (IBDs) are lacking. Therefore, we aimed to verify the ability of ABP501 and SB5 to maintain the clinical and biochemical response induced by the ADA originator, after switching to them. We prospectively analyzed data collected from 55 patients with IBD who switched to ABP501, and 25 patients with IBD who switched to SB5, from ADA originator at four IBD Units between 2018 and 2020. In addition, we included an age and sex-matched control group (n = 38) who continued ADA originator for at least two years and who did not switch to a biosimilar drug. Clinical and biochemical data (C-Reactive Protein (CRP), fecal calprotectin (FC)), concomitant steroid and/or immunosuppressant therapy at the time of the switch and after six months were collected. At six months, in the ABP501 group, we did not observe statistically significant modifications in clinical activity of disease (p = 0.09) and FC values (p = 0.90). Some patients (n = 8) needed to add steroids at six months after switching (p = 0.01), however the need for optimization was not significant between the two timepoints (p = 0.70). Finally, 14.5% patients stopped therapy after six months. Similarly, in the SB5 group we observed a stability of clinical activity and FC values (p = 0.90 and p = 0.20), and a concomitant statistically significant decrease in CRP (p = 0.03). There were no differences in steroids/immunosuppressants need or optimizing biological therapy in this group. Finally, drug survival curves of patients who switched from originator to ABP501 and those who continued ADA originator were similar (p = 0.20). Overall, biosimilar drugs seem to be as effective and safe as the originator. Further larger and longer studies are mandatory to understand the clinical implications of these findings.

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Section: Aesmentioning

confidence: 99%

Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator

Cingolani

Barberio

Zingone

et al. 2021

Sci Rep

Self Cite

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show abstract

“…Inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), are chronic remitting and relapsing diseases, with a significant impact on quality of life and social functioning, as well as psychological health. [1][2][3][4] Almost 50% of patients will develop extraintestinal manifestations during their lifetime, with a further impact on disease outcomes. 1,2,5 Among these manifestations, there are those affecting the hepatobiliary tract, such as primary sclerosing cholangitis (PSC), characterized by inflammation and fibrosis of intrahepatic and extrahepatic bile ducts, with eventual evolution to cirrhosis and malignancy in the majority of patients.…”

Section: Introductionmentioning

confidence: 99%

Prevalence of Primary Sclerosing Cholangitis in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis

et al. 2021

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“…Inflammatory Bowel Diseases (IBDs), including Ulcerative Colitis (UC) and Crohn’s Disease (CD), are chronic disorders of the intestinal tract characterized by relapsing and remitting intestinal inflammation and are associated with a reduced quality of life. 1 – 6 The introduction of biological drugs has radically changed the therapeutic approach and management of IBD patients. 1 …”

Section: Introductionmentioning

confidence: 99%

Switching from Infliximab Originator to SB2 Biosimilar in Inflammatory Bowel Diseases: A Multicentric Prospective Real-Life Study

Massimi

Barberio

Bertani

et al. 2021

Therap Adv Gastroenterol

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Background: Current literature still lacks studies evaluating the effectiveness and safety of switching from Infliximab originator to SB2 biosimilar in Inflammatory Bowel Diseases (IBDs). We aimed to verify the ability of SB2 to maintain the clinical and biochemical response induced by originator after switching. As secondary outcome, we aimed to verify safety, tolerability and immunogenicity of SB2 biosimilar compared with its IFX originator. Methods: We prospectively enrolled all patients who switched from originator to SB2 at three Italian IBD Units from August 2018 to April 2020. We collected clinical and biochemical data at the time of switch (T0), and at the first (T1) and the second (T2) visits after switching (mean time from switching: 135 and 329 days, respectively). In addition, data regarding therapeutic drug monitoring at T0 and T1 were recorded. Results: Eighty-five IBD patients (28 with Ulcerative Colitis and 57 with Crohn’s Disease) were included in the study. At T1, we observed statistically significant modifications in clinical activity of disease (70 patients were in clinical remission at baseline and 60 at T1 p = 0.02), but not at T2 (p = 0.3). Fecal calprotectin values were not different both at T1 and T2 (both p = 0.9) as well as the rate of concomitant treatment with steroids (p = 0.2 and p = 0.1) or immunosuppressants (p = 0.1 and p = 1.0). Moreover, the need for therapeutic optimization from T0 to T1 and from T1 to T2 was found significant (both p = 0.01). No anti-drug antibodies were identified at T1, and no serious adverse events were recorded. Conclusions: Overall, our data show that most of the patients switching from Infliximab originator to SB2 maintain the clinical and biochemical remission for at least 1 year. Further data are necessary to understand the clinical implications of these findings in the long term.

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Inflammatory Bowel Disease and Sleep Disturbance: As Usual, Quality Matters

Cited by 15 publications

References 9 publications

Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator

Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator

Prevalence of Primary Sclerosing Cholangitis in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis

Switching from Infliximab Originator to SB2 Biosimilar in Inflammatory Bowel Diseases: A Multicentric Prospective Real-Life Study

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