scholarly journals Seizure During Infliximab Infusion in a Child With Crohn’s Disease: An Illustration of a Neurologic Adverse Event Associated With Drug Antibodies

JPGN Reports ◽  
2021 ◽  
Vol 2 (3) ◽  
pp. e101
Author(s):  
Shelly Joseph ◽  
Anna W Reed ◽  
Carmen Cuffari
Keyword(s):  
Adverse Event ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Infliximab Infusion

scholarly journals The Safety Profile of Vedolizumab in Ulcerative Colitis and Crohn’s Disease: 4 Years of Global Post-marketing Data

2019 ◽  
Vol 14 (2) ◽  
pp. 192-204 ◽  
Author(s):  
Russell D Cohen ◽  
Fatima Bhayat ◽  
Aimee Blake ◽  
Simon Travis
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Event ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Safety Profile ◽  
Safety Data ◽  
Real World Data ◽  
Safety Database ◽  
Post Marketing

Abstract Background and Aims Vedolizumab is a gut-selective antibody to α 4  β 7 integrin, approved to treat moderate-to-severe ulcerative colitis and Crohn’s disease in adults. Clinical trial data on patients meeting protocol-specified criteria may not reflect real-world clinical practice. This is a descriptive analysis of 4 years of post-marketing safety data on vedolizumab. Methods The Vedolizumab Global Safety Database contains all adverse event reports collated by Takeda Pharmaceutical Company Ltd since vedolizumab approval [May 20, 2014]. Adverse event reports received between approval and May 19, 2018 were identified using Medical Dictionary for Regulatory Activities version 21.0 Preferred Terms. Adverse event frequencies were calculated and categorised. Results In approximately 208 050 patient-years of vedolizumab exposure, 32 752 patients reported 80 218 events. In patients with Crohn’s disease or ulcerative colitis, 37 662 and 34 259 events occurred in 14 191 and 14 042 patients, respectively, and 8297 events occurred in 4519 individuals with other [off-label] or unreported indications. Overall, 5230 [14%; Crohn’s disease] and 3580 [10%; ulcerative colitis] events were serious. Most frequently reported were gastrointestinal events (Crohn’s disease, 6156 [16%]; ulcerative colitis, 5701 [17%]). Patients with Crohn’s disease or ulcerative colitis reported 251 malignancies [<1%], 402 hepatobiliary events [<1%], and 5876 infections (1137 serious [19%], 301 opportunistic [5%]). Patients aged ≥70 years [2326 patients] reported <10% of events. Conclusions Adverse event patterns were consistent with clinical trials, with no new safety concerns. Most reported events were non-serious and event frequency was low, considering patient-years of exposure. Although limitations of post-marketing safety reports require acknowledgement, these real-world data support a favourable safety profile of vedolizumab.

Results of Seton Drainage and Infliximab Infusion for Complex Anal Crohn's Disease

2011 ◽  
Vol 58 (109) ◽  
pp. 1189-1192 ◽  
Author(s):  
Masayuki Hotokezaka ◽  
Takuto Ikeda ◽  
Shuichiro Uchiyama ◽  
Kazuyo Tsuchiya ◽  
Kazuo Chijiiwa
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Infliximab Infusion ◽  
Seton Drainage

scholarly journals Combined therapy with early initiation of infliximab following drainage of perianal fistulising Crohn’s disease: a retrospective cohort study

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Ping Zhu ◽  
Jin-fang Sun ◽  
Yun-fei Gu ◽  
Hong-jin Chen ◽  
Min-min Xu ◽  
...  
Keyword(s):  
Cohort Study ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Maintenance Therapy ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Early Initiation ◽  
Infliximab Infusion ◽  
Induction Group ◽  
Fistula Healing

Abstract Background Recent studies have confirmed that combined surgery and anti-TNF therapy could improve outcomes in patients with perianal fistulising Crohn’s disease (PFCD). However, the optimal timing for infliximab infusion after surgical intervention is uncertain. We aimed to determine the long-term efficacy of early initiation of infliximab following surgery among PFCD patients. Methods We performed a retrospective cohort study of PFCD patients who received combined infliximab and surgical treatment between 2010 and 2018 at a tertiary referral hospital. Patients were grouped according to the time interval between surgery and infliximab infusion, with < 6 weeks into early infliximab induction group and > 6 weeks into delayed infliximab induction group. The primary outcome was to compare surgical re-intervention between early and delayed infliximab induction groups. The secondary outcomes were fistula healing and predictors associated with these outcomes of early infliximab induction approach. Results One hundred and seventeen patients were included (73 in early infliximab induction, 44 in delayed infliximab induction). The median interval between surgery and infliximab initiation was 9.0 (IQR 5.5–17.0) days in early infliximab induction group and 188.0 (IQR 102.25–455.75) days in delayed infliximab induction group. After followed-up for a median of 36 months, 61.6% of patients in early infliximab induction group and 65.9% in delayed infliximab induction group attained fistula healing (p = 0.643). The cumulative re-intervention rate was 23%, 32%, 34% in early infliximab induction group and 16%, 25%, 25% in delayed infliximab induction group, at 1, 2, and 3 years respectively (p = 0.235). Presence of abscess at baseline (HR = 5.283; 95% CI, 1.61–17.335; p = 0.006) and infliximab maintenance therapy > 3 infusions (HR = 3.691; 95% CI, 1.233–11.051; p = 0.02) were associated with re-intervention in early infliximab induction group. Presence of abscess at baseline also negatively influenced fistula healing (HR = 3.429, 95% CI, 1.216–9.668; p = 0.02). Conclusion Although no clear benefit was shown compared with delayed infliximab induction group, early initiation of infliximab after surgery could achieve promising results for PFCD patients. Before infliximab infusion, durable drainage is required for patients with concomitant abscess or prolonged infliximab maintenance therapy.

scholarly journals The impact of infliximab infusion reactions on long-term outcomes in patients with Crohn’s disease

2008 ◽  
Vol 28 (2) ◽  
pp. 221-227 ◽  
Author(s):  
A. C. MOSS ◽  
N. FERNANDEZ-BECKER ◽  
K. JO KIM ◽  
D. CURY ◽  
A. S. CHEIFETZ
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Long Term Outcomes ◽  
Infliximab Infusion ◽  
Infusion Reactions ◽  
The Impact

Bilateral Sub-deltoid Bursitis in a Patient Receiving Infliximab for Crohn's Disease

2020 ◽  
Vol 15 (1) ◽  
pp. 77-80 ◽  
Author(s):  
Syrine Bellakhal ◽  
Maissa Abbes ◽  
Mohamed Taieb Jomni ◽  
Imen Abdelaali ◽  
Mehdi Charfi ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Case Report ◽  
Side Effects ◽  
Crohn's Disease ◽  
Acute Onset ◽  
Drug Discontinuation ◽  
Clinical Expression ◽  
Perineal Fistula ◽  
Infliximab Infusion ◽  
Bowel Diseases

Background: Infiximab has been shown to be effective in inducing and maintaining remission of intestinal bowel diseases. Infiximab has been associated with many adverse events. Articular manifestations are commonly reported, but they are of variable clinical expression and aetiology. Among them, inflammatory bursitis has rarely been described. Objective: Herein a case of inflammatory bursitis in a patient with Crohn’s disease after switching to biosimilar infliximab is reported. Case Report:: A 41-year-old man with Crohn’s disease evolving from 3 years was referred to infliximab therapy at a dose of 5mg/kg because of an aggressive resistant perineal fistula. After 14 infusions of infliximab, the treatment was switched to infliximab biosimilar using the same dose and frequency of administration. Discussion: The diagnosis of non-infective sub-acromial bursitis secondary to infliximab infusion was made as the patient’s symptoms resolved rapidly without any antibiotics. Infliximab was definitively stopped and adalimumab was introduced. : Forty-eight hours after the second infusion, he developed an acute onset of muscle pain and stiffness on both of his shoulders. A musculoskeletal ultrasound was performed and revealed a hypoechoic widening of both subacromial bursae. It was more severe on the left side. Conclusions: Musculoskeletal side effects of infliximab infusion are uncommonly reported. Among them, bursitis has been reported in only a few cases. Ultrasonography can help early diagnosis of bursitis. The time of occurring of this reaction regarding infliximab infusion, screening of Antibodies to Infliximab (ATI) and clinical outcome after drug discontinuation are the main helpful arguments.

scholarly journals Combined Therapy With Early Initiation of Infliximab After Surgery for Perianal Fistulising Crohn’s Disease : A Retrospective Cohort Study

2021 ◽  
Author(s):  
Ping Zhu ◽  
Jin-fang Sun ◽  
Yun-fei Gu ◽  
Hong-jin Chen ◽  
Min-min Xu ◽  
...  
Keyword(s):  
Cohort Study ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Combined Therapy ◽  
Early Initiation ◽  
Combination Group ◽  
Fistula Closure ◽  
Infliximab Infusion

Abstract Background: Recent studies have recognized that combined surgery and anti-TNF therapy could improve clinical outcomes in patients with perianal fistulising Crohn’s disease (PFCD). However, the optimal timing for infliximab infusion after surgical intervention is uncertain. We aimed to determine the long-term efficacy of early initiation of infliximab after surgery among patients who received combination therapy for PFCD.Methods: We performed a retrospective cohort study of PFCD patients who received combined infliximab and surgical treatment between 2010 and 2018 at a tertiary referral hospital. Patients were grouped according to the time interval between surgery and infliximab infusion, with < 6 weeks into early combination group and > 6 weeks into conventional combination group. The primary outcome was to compare fistula closure and surgical re-intervention between early and conventional combination groups. The secondary outcomes were predictors associated with these outcomes of early combination approach.Results: One hundred and seventeen patients were included (73 in early combination, 44 in conventional combination). The median interval between surgery and initial infliximab infusion was 9.0 (IQR 5.5-17.0) days in early combination group and 188.0 (IQR 102.25-455.75) days in conventional combination group. After followed-up for a median of 36 months, 61.6% of patients in early combination group and 65.9% patients in conventional combination group derived fistula closure (p=0.643). The cumulative re-intervention rate was 23%, 32%, 35% in early combination group and 16%, 24%, 24% in conventional combination group, at 1, 2, and 3 years respectively (P=0.235). Presence of abscess (HR = 5.283; 95% CI, 1.61-17.335; p = 0.006) and maintenance infliximab therapy > 3 times (HR = 3.691; 95% CI, 1.233-11.051; p = 0.02) were associated with re-intervention in early combination group. Presence of abscess also negatively influences fistula closure (HR = 3.429, 95% CI, 1.216-9.668; p = 0.02).Conclusion: Combined therapy with early initiation of infliximab after surgery could achieve promising results for PFCD patients. Durable drainage should be established for patients with concomitant abscess or requiring infliximab maintenance before infliximab initiation.

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