scholarly journals Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study

2021 ◽  
Vol 10 (15) ◽  
pp. 3387
Author(s):  
Davide Giuseppe Ribaldone ◽  
Elisa Tribocco ◽  
Chiara Rosso ◽  
Angelo Armandi ◽  
Marta Vernero ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Final Analysis ◽  
Real World Data ◽  
Reactive Protein ◽  
Systemic Corticosteroids ◽  
Signs Of Safety ◽  
Abp 501 ◽  
A Prospective Study ◽  
Multiple Switching

No data are available regarding the safety and effectiveness of the biosimilar-to-biosimilar switch of adalimumab in any disease, and in particular in Crohn’s disease (CD). The aim of our study was to provide real world data on switching from biosimilar adalimumab to another biosimilar, including multiple switching. We conducted a prospective, single-centre observational study in which we consecutively recruited all CD patients who switched from adalimumab biosimilar ABP 501 to biosimilar SB5 from January to July 2021. Sixty-one patients were included in the final analysis, of whom 43/61 (70.5%) were multiple switches (Humira® → ABP 501 → SB5). After 6 months of follow up, 88.5% (54/61) of patients maintained SB5 on therapy. The success of the switch (defined as no systemic corticosteroids within 6 months, non-discontinuation of SB5, no dose escalation) was achieved by 82.0% (50/61) of patients. At multivariate analysis, C-reactive protein > 5 mg/L predicted switch failure (p = 0.03). Seven patients (11.5%) experienced side effects, compared to one patient (1.6%) in the 6 pre-switch months (p = 0.03). In conclusion, switching from biosimilar to biosimilar of adalimumab did not lead to signs of safety or loss of efficacy other than those already known in the literature for the class of drugs.

scholarly journals Adalimumab Therapy Improves Intestinal Dysbiosis in Crohn's Disease

2019 ◽  
Vol 8 (10) ◽  
pp. 1646 ◽  
Author(s):  
Davide Giuseppe Ribaldone ◽  
Gian Paolo Caviglia ◽  
Amina Abdulle ◽  
Rinaldo Pellicano ◽  
Maria Chiara Ditto ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Gut Microbiota ◽  
Response To Treatment ◽  
Biologic Drugs ◽  
Therapeutic Success ◽  
Bacterial Phyla ◽  
Reactive Protein ◽  
Adalimumab Therapy ◽  
A Prospective Study

The response to treatment with biologic drugs, in patients with Crohn’s disease, could be associated with changes in gut microbiota composition. The aim of our study was to analyse the modification of microbiota during adalimumab therapy in patients with Crohn’s disease. We performed a prospective study in patients with Crohn’s disease analysing gut microbiota before start of adalimumab therapy (T0) and after six months of therapy (T1). Among the 20 included patients, the phylum Proteobacteria fell from 15.7 ± 3.5% at T0 to 10.3 ± 3.4% at T1 (p = 0.038). Furthermore, the trend in relation to therapeutic success was analysed. Regarding bacterial phyla, Proteobacteria decreased in patients in whom therapeutic success was obtained, passing from a value of 15.8% (± 4.6%) to 6.8 ± 3.1% (p = 0.049), while in non-responder patients, percentages did not change (T0 = 15.6 ± 5.7%, T1 = 16.8 ± 7.6%, p = 0.890). Regarding the Lachnospiraceae family, in patients with normalization of C reactive protein six 6 months of adalimumab therapy, it increased from 16.6 ± 3.1% at T0 to 23.9 ± 2.6% at T1 (p = 0.049). In conclusion, in patients who respond to Adalimumab therapy by decreasing inflammation, there is a trend of intestinal eubiosis being restored.

scholarly journals Ustekinumab for Crohn’s Disease: Results of the ICC Registry, a Nationwide Prospective Observational Cohort Study

2019 ◽  
Vol 14 (1) ◽  
pp. 33-45 ◽  
Author(s):  
Vince B C Biemans ◽  
Andrea E van der Meulen - de Jong ◽  
Christine J van der Woude ◽  
Mark Löwenberg ◽  
Gerard Dijkstra ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Anal Fistula ◽  
Clinical Remission ◽  
Real World Data ◽  
Effective Treatment Option ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Regular Care

Abstract Background and Aims Ustekinumab is approved for the treatment of Crohn’s disease [CD]. Systematically registered prospective real-world data are scarce. We therefore aimed to study the effectiveness, safety and usage of ustekinumab for CD in everyday practice. Methods We prospectively enrolled CD patients initiating ustekinumab in regular care between December 2016 and January 2019. Clinical (Harvey Bradshaw Index [HBI]), biochemical (C-reactive protein [CRP] and faecal calprotectin [FCP]), extra-intestinal manifestations and, peri-anal fistula activity, ustekinumab dosage, concomitant medication use, and adverse events were documented at weeks 0, 12, 24, and 52. The primary outcome was corticosteroid-free clinical remission. Results In total, 221 CD patients were included (98.6% anti-tumour necrosis factor [TNF] and 46.6% vedolizumab exposed) with a median follow-up of 52.0 weeks [interquartile range 49.3–58.4]. Corticosteroid-free clinical remission rates at weeks 24 and 52 were 38.2% and 37.1%, respectively. An initial dosing schedule of 8 weeks, compared to 12 weeks, correlated with a lower discontinuation rate [20.0% vs 42.6%, p = 0.01], but comparable corticosteroid-free clinical remission at week 52 (46.3% [q8w] vs 34.6% [q12w], p = 0.20). There was no clinical benefit of combination therapy after 52 weeks when compared to ustekinumab monotherapy [combi 40.6% vs mono 36.0%, p = 0.64]. At baseline, 28 patients had active peri-anal fistula, of whom 35.7% showed complete clinical resolution after 24 weeks. During follow-up we encountered six severe infections [3.5 per 100 patient-years], with all patients being on concomitant immunosuppressant therapies. Ustekinumab treatment discontinuation was observed in 75 [33.9%] patients mainly due to lack of response. Conclusion Ustekinumab is a relatively safe and effective treatment option for CD patients with prior failure of anti-TNF and anti-integrin therapies.

The Correlation between Vitamin D Levels and the Risk of Postoperative Recurrence in Crohn’s Disease

Digestion ◽  
2021 ◽  
pp. 1-9
Author(s):  
Akihiro Yamada ◽  
Yuga Komaki ◽  
Fukiko Komaki ◽  
Haider Haider ◽  
Dejan Micic ◽  
...  
Keyword(s):  
Vitamin D ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Postoperative Recurrence ◽  
Recurrence Rates ◽  
Reactive Protein ◽  
Endoscopic Recurrence ◽  
Vitamin D Levels ◽  
Endoscopic Remission ◽  
The University

<b><i>Background and Aims:</i></b> Vitamin D deficiency has been associated with disease activity in Crohn’s disease (CD). We assessed whether there is a correlation between vitamin D levels and the risk of postoperative recurrence in CD. <b><i>Methods:</i></b> CD patients who underwent surgery were identified from a prospectively maintained database at the University of Chicago. The primary endpoint was the correlation of serum 25-hydroxy vitamin D levels measured at 6–12 months after surgery and the proportion of patients in endoscopic remission, defined as a simple endoscopic score for CD of 0. Clinical, biological (C-reactive protein), and histologic recurrences were also studied. <b><i>Results:</i></b> Among a total of 89 patients, 17, 46, and 26 patients had vitamin D levels of &#x3c;15, 15–30, and &#x3e;30 ng/mL, respectively. Patients with higher vitamin D levels were significantly more likely to be in endoscopic remission compared to those with lower levels (23, 42, and 67% in ascending tertile order; <i>p</i> = 0.028). On multivariate analysis, vitamin D &#x3e;30 ng/mL (odds ratio [OR] 0.22, 95% confidence interval [CI] 0.07–0.66, <i>p</i> = 0.006) and anti-tumor necrosis factor agent treatment (OR 0.25, 95% CI 0.08–0.83, <i>p</i> = 0.01) were associated with reduced risk of endoscopic recurrence. Rates of clinical, biological, and histologic remission trended to be higher in patients with higher vitamin D levels (<i>p</i> = 0.17, 0.55, 0.062, respectively). <b><i>Conclusion:</i></b> In the present study, higher vitamin D level was associated with lower risk of postoperative endoscopic CD recurrence. Further, studies are warranted to assess the role of vitamin D in postoperative CD recurrence.

Combined evaluation of fecal calprotectin and C-reactive protein as a therapeutic target in the management of patients with Crohn's disease

2021 ◽  
Vol 44 (2) ◽  
pp. 87-95
Author(s):  
Francisco Guilherme Cancela Penna ◽  
Rodrigo Macedo Rosa ◽  
Fernando H. Pereira ◽  
Pedro Ferrari Sales Cunha ◽  
Stella Cristina S. Sousa ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Therapeutic Target ◽  
Fecal Calprotectin ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Combined Evaluation

Long-term Disease Behavior and Surgical Intervention Analysis in Hospitalized Patients with Crohn's Disease in China: A Retrospective Cohort Study

2021 ◽  
Author(s):  
Xiaoyin Bai ◽  
Huimin Zhang ◽  
Gechong Ruan ◽  
Hong Lv ◽  
Yue Li ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Large Scale ◽  
Hospitalized Patients ◽  
Disease Classification ◽  
Real World Data ◽  
Disease Behavior ◽  
Initial Classification

Abstract Background There is lack of real-world data for disease behavior and surgery of Crohn’s disease (CD) from large-scale Chinese cohorts. Methods Hospitalized patients diagnosed with CD in our center were consecutively included from January 2000 to December 2018. Disease behavior progression was defined as the initial classification of B1 to the progression to B2 or B3. Clinical characteristics including demographics, disease classification and activity, medical therapy, development of cancers, and death were collected. Results Overall, 504 patients were included. Two hundred and thirty one (45.8%) patients were initially classified as B1; 30 (13.0%), 71 (30.7%), and 95 (41.1%) of them had disease progression at the 1-year follow-up, 5-year follow-up, and overall, respectively. Patients without location transition before behavior transition were less likely to experience behavior progression. However, patients without previous exposure to a corticosteroid, immunomodulator, or biological agent had a greater chance of experiencing behavior progression. When the long-term prognosis was evaluated, 211 (41.9%) patients underwent at least one CD-related surgery; 108 (21.4%) and 120 (23.8%) of these patients underwent surgery before and after their diagnosis, respectively. An initial classification as B1, no behavior transition, no surgery prior to diagnosis, and previous corticosteroid exposure during follow-up were associated with a lower risk of undergoing surgery. Conclusions This study depicts the clinical features and factors associated with behavior progression and surgery among hospitalized CD patients in a Chinese center. Behavior progression is associated with a higher probability of CD-related surgery, and strengthened therapies are necessary for them in the early phase.

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