scholarly journals Clinical Experience with Infliximab for Crohn’s Disease: The First 100 Patients in Edmonton, Alberta

2002 ◽  
Vol 16 (3) ◽  
pp. 165-170 ◽  
Author(s):  
Clifford Sample ◽  
Robert J Bailey ◽  
Dennis Todoruk ◽  
Daniel Sadowski ◽  
Gramlich Leah ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Patient Group ◽  
Response Rate ◽  
Complete Response ◽  
Infusion Reaction ◽  
Clinical Response Rate ◽  
Randomized Controlled Clinical Trials ◽  
Duration Of Response

OBJECTIVE: To determine whether the clinical efficacy and safety of infliximab in diverse clinical referral practices was similar to that seen in the randomized, controlled clinical trials.METHODS: Data were gathered from a review of charts of 109 consecutive patients with inflammatory and/or fistulizing Crohn’s disease who received infliximab infusions. Responses were recorded based on the physician’s global clinical assessment and classified as complete, partial or nonresponse.RESULTS: One hundred nine patients were treated with one to nine infusions of infliximab at a dose of 5 mg/kg and followed up for a median of 24 weeks (range one to 40 weeks). Fifty-four patients were treated for inflammatory disease, 38 for fistulizing disease and 17 for both. Clinical response occurred in 73% (17% complete response, 55% partial response). The clinical response rate did not vary relative to patient demographics, disease distribution, indication for infliximab, or the concomitant use of corticosteroids or immune modifiers. For those taking concomitant immune modifiers, the response rate was 75%. The median time to response was two weeks (range one to six weeks). The median duration of response was 12 weeks (range six to 88 weeks). Reduction or cessation of steroids was possible in 17 of 32 patients. Adverse events related to infliximab occurred in 7% of patients. These events were characterized as mild and did not require stoppage of infliximab therapy, except in one patient who had a treatable anaphylactic-like infusion reaction.CONCLUSIONS: The patient group in the present study realized significant clinical benefit, with minimal adverse effects, following treatment with infliximab. Clinical response rates paralleled those previously described in placebo controlled trials and retrospective clinical practice reviews. Nevertheless, the complete response rate (ie, remission) in this patient group was lower than that previously described.

Mucosal Biomarker of Innate Immune Activation Predicts Response to Vedolizumab in Crohn’s Disease

2019 ◽  
Author(s):  
Mark T Osterman ◽  
Ilyssa O Gordon ◽  
Elisabeth M Davis ◽  
Matthew Ciorba ◽  
Sarah C Glover ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Immune Activation ◽  
Clinical Remission ◽  
Response Rate ◽  
Intestinal Inflammation ◽  
Innate Immune ◽  
Clinical Response Rate ◽  
Innate Immune Activation

Abstract Objective Mucosal barrier dysfunction plays a crucial role in intestinal inflammation in Crohn’s disease (CD). Intestinal epithelial cell (IEC) death resulting from innate immune activation, termed pyroptosis, was recently found to be a cause of this barrier defect. The aim of this study was to determine the predictive value of pretreatment ileal biopsy pyroptosis as a biomarker for clinical response to vedolizumab in CD. Design Crohn’s disease patients ranging 18 to 80 years old from 5 IBD centers with pre-vedolizumab ileal biopsies during colonoscopy were enrolled. Biopsies were stained for activated caspases, and levels of ileal IEC pyroptosis levels were quantified. The primary outcome was clinical response 6 months after therapy, defined as a reduction of Harvey-Bradshaw Index (HBI) of ≥5 points from baseline. Secondary outcomes included clinical remission, defined as HBI <5, and endoscopic improvement, as measured by the Simple Endoscopic Score for Crohn’s Disease (SES-CD). Results One hundred CD patients (45 male, 55 female), median age 47 (19, 78) years, were included; clinical response rate was 60%, and clinical remission was 36%. The response rate in patients with ileal pyroptosis <14 positive cells per 1000 IECs was significantly higher than those above the threshold: 89% (25 of 28) vs 49% (35 of 72), odds ratio (OR) 8.8 (95% CI, 2.3–48.6; P < 0.001). Corresponding remission rates were 54% (15 of 28) vs 29% (21 of 72; OR 2.8 [1.03–7.59; P = 0.036]). For endoscopic improvement, ileal pyroptosis of 22 positive cells per 1000 IECs was the optimal threshold that determines the magnitude SES-CD change. Conclusions Ileal biopsy IEC pyroptosis was predictive of clinical response and endoscopic improvement to vedolizmab in CD patients.

Cisplatin, carboplatin, and cyclophosphamide combination chemotherapy in advanced-stage ovarian carcinoma: an Eastern Cooperative Oncology Group pilot study.

1991 ◽  
Vol 9 (10) ◽  
pp. 1793-1800 ◽  
Author(s):  
J Grem ◽  
P O'Dwyer ◽  
P Elson ◽  
N Simon ◽  
D Trump ◽  
...  
Keyword(s):  
Clinical Response ◽  
Response Rate ◽  
Residual Disease ◽  
Eastern Cooperative Oncology Group ◽  
Dose Intensity ◽  
Complete Response ◽  
Clinical Response Rate ◽  
Hematologic Toxicity ◽  
Survival Times ◽  
Moderate Nausea

Cyclophosphamide (CTX) 600 mg/m2, carboplatin 280 mg/m2, and cisplatin 50 mg/m2 were administered on day 1 every 4 weeks to 41 previously untreated ovarian cancer patients with residual disease greater than 2.0 cm after primary laparotomy. Of 22 patients with measurable disease treated with up to eight cycles of therapy, the overall clinical response rate was 73% (exact 95% confidence interval [CI], 50% to 89%), with 50% complete response (CR). Six of 11 clinical CR (cCR) patients underwent surgical restaging; three pathologic CRs (pCRs) and three pathologic partial responses (pPRs) with residual disease less than 2.0 cm were documented. Fourteen patients had nonmeasurable but assessable disease; the clinical response rate was 57% (Cl, 29% to 82%) with two (14%) CRs. Second-look surgery was performed in one of the two cCR patients; a pPR was documented. Five patients with nonassessable disease were stable during chemotherapy; two underwent surgery and had pCRs. The median time to treatment failure (TTF) was 14.8 months, and median survival for the 41 patients is 26.7 months. Overall, 37% of the patients had progression-free intervals of at least 2 years, and 27% have survival times in excess of 3 years. Hematologic toxicity was substantial but manageable, with 58% and 66% experiencing a granulocyte nadir less than 500/microL and a platelet nadir less than 50,000/microL, respectively. One treatment-associated fatality occurred as a result of leukopenic sepsis and renal failure in the setting of progressive disease and ureteral obstruction. Mild to moderate nausea and vomiting occurred in most patients, but none experienced severe ototoxicity or peripheral neuropathy. Over all courses, 73% of the projected dose intensity of CTX and carboplatin and 86% of cisplatin were delivered. Since granulocytopenia and thrombocytopenia were dose-limiting, the addition of colony-stimulating factors that support both myeloid and megakaryocyte precursors may permit further dose intensification.

scholarly journals P613 Use of adalimumab biosimilar ABP 501 in Crohn’s disease: A real-life experience

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S510-S511
Author(s):  
D G Ribaldone ◽  
M Vernero ◽  
R Pellicano ◽  
M Morino ◽  
G M Saracco ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Clinical Response ◽  
Clinical Remission ◽  
Retention Rate ◽  
Real Life ◽  
University Hospital ◽  
Clinical Response Rate ◽  
Abp 501

Abstract Background The use of biologics in Crohn’s disease (CD) entails an increasing cost on national health systems. The use of biosimilars of adalimumab in CD is based on the concept of extrapolation of the results obtained in rheumatoid arthritis and in psoriasis, while no study about the efficacy and safety on CD of the biosimilars approved in Europe have been published. The aim of our study was to analyse, for the first time in literature, the effectiveness and safety of ABP 501 in CD patients naïve to adalimumab and its retention rate in CD patients who switched from adalimumab originator. Methods We performed an observational study on patients prospectively followed at the gastroenterology clinic of the Turin University Hospital. Inclusion criteria are (a) CD diagnosed according to ECCO criteria; (b) age ≥16 years; (c) initiation of therapy with ABP 501. Exclusion criterian is follow-up duration of less than 3 months for adalimumab-naïve patients, less than 6 months for patients who switched to ABP 501. Primary outcomes were (a) for patients treated with ABP 501 as first adalimumab: clinical response rate at 12 weeks and (b) for patients who switched to ABP 501: drug retention at 24 weeks. Secondary outcomes were (a) clinical remission rate at week 12 (for patients treated with ABP 501 as first adalimumab); (b) HBI and CRP reduction at week 12 (for patients treated with ABP 501 as first adalimumab), no significant change in HBI and CRP values at week 24 (for patients who switched to ABP 501); (c) analysis of predictors; and (d) adverse events incidence. Results Eighty-seven patients were included, of which 25 were naïve to adalimumab originator and 62 were switched to ABP 501. In adalimumab-naïve patients, the clinical response at 3 months was 60% (15/25), clinical remission at 3 months was 56% (14/25). At 6 months, 95.2% (59/62) of the patients switched to ABP 501 were still in therapy, without a significant increment of clinical activity (Harvey–Bradshaw Index from 3.4, 95% CI = 2.4 – 4.4, to 3.8, 95% CI = 2.7 – 4.9, p = 0.23), and inflammatory biomarker (CRP from 4.2 mg/l, 95% CI = 2.5 mg/l – 5.9 mg/l, to 3.6 mg/l, 95% CI = 2.2 mg/l – 5 mg/l, p = 0.32). No unexpected adverse events occurred during the study period. Conclusion Our results support ABP 501 as an efficacious and well-tolerated drug, at least in the short-term, and its interchangeability with its originator in the treatment of CD.

S-1 plus oxaliplatin compared with fluorouracil/leucovorin/oxaliplatin as neoadjuvant chemotherapy for locally advanced gastric carcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 147-147
Author(s):  
Jiren Yu ◽  
Yijun Wu ◽  
Yuan Gao ◽  
Qianyun Shen ◽  
Qing Zhang ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Gastric Carcinoma ◽  
Clinical Response ◽  
Response Rate ◽  
Locally Advanced ◽  
Preoperative Staging ◽  
Complete Response ◽  
Clinical Response Rate ◽  
R0 Resection ◽  
Advanced Gastric Carcinoma

147 Background: Perioperative chemotherapy could improve the prognosis compared with surgery alone. This study is to compare the efficacy and safety of S-1 and oxaliplatin (SOX) with fluorouracil, leucovorin and oxaliplatin (FOLFOX) as neoadjuvant chemotherapy for locally advanced gastric carcinoma. Methods: Patients with histologically confirmed locally advanced gastric carcinoma were enrolled and divided into two groups. Preoperative staging and response evaluation was achieved mainly by gastroscopy and abdominal computer tomography. Neoajuvant chemotherapy consisted of 2-6 cycles of S-1 80mg/m2 (2-week administration and 1-week rest) plus oxaliplatin 130mg/m2 on Day1 in SOX group, or 2 h infusion of 130mg/m2 oxaliplatin plus 2h infusion of 400 mg/m2 leucovorin, followed by infusion of 400 mg/m2 5-fluorouracil on Day 1 and 46 h 2.4 g/m2 bolus in FOLFOX group. The clinical response was evaluated after 2 cycles of chemotherapy, and surgery was attempted. Results: From 2009.9 to 2011.5, 88 patients were enrolled in this study(56 in SOX and 32 in FOLFOX). The clinical response rate was significant higher in the SOX compared with FOLFOX (54.7% vs. 31.2%, p=0.03). 68 patients received surgery(45 in SOX and 23 in FOLFOX), R0 resection rate was similar in both group (SOX: 93.3% vs. FOLFOX: 82.6%, p=0.22). Pathological complete response was observed in 3 patients in SOX group. All enrolled patients were evaluated for the adverse events (AE). The most common non-hematological AE was nausea (57.1% in SOX and 50% in FOLFOX) and vomiting (41.1% in SOX and 40.6% in FOLFOX). The major hematological AE included thrombocytopenia (37.5% in SOX and 21.9% in FOLFOX), neutropenia (33.9% in SOX and 53.1% in FOLFOX) and leukocytopenia (32.1% in SOX and 40.6% in FOLFOX). Conclusions: SOX had higher response rate and acceptable toxicity compared with FOLFOX as neoadjuvant chemotherapy.

Induction in locally advanced uterine cervix carcinoma with cisplatin, paclitaxel, and capecitabine: Response and tolerability.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16521-e16521
Author(s):  
Juan J. Rodriguez-Riao ◽  
George Oblitas ◽  
Virgilio Colon
Keyword(s):  
Clinical Response ◽  
Induction Chemotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Complete Response ◽  
Cervix Cancer ◽  
Clinical Response Rate ◽  
Hematologic Toxicity ◽  
Cervix Carcinoma ◽  
Grade 3

e16521 Background: Cervix cancer is a public health problem in developing countries, and the locally advanced disease is the most common stage and patiente with complete response after concurrent radiotherapy and cisplatin is low. In this study we use induction chemotherapy in orden to reduce the tumor before radiotherapy administration. Methods: 47 patients with pathological confirmed cervix cancer stage Ib2 to IVa received induction chemotherapy for three cycles with cisplatin, paclitaxel and capecitabine prior to treatment with concurrent chemotherapy-radiotherapy. The primary end points were clinical response rate, pathological response and imaging after induction and secondary end point was safety (NCI toxicity version 3.0). Results: A total of 47 patients found that the average age was 45 years, stage IIB was the most common, squamous histology representing 89.4% of the patients. The clinical response rate was 100%, without disease progression during the period of following. Pathological complete response was 48.9%. The most common hematologic toxicity was anemia (55%) and grade 3 neutropenia (14.8%) but both were manageable, all patients had hand-foot syndrome and alopecia. Neuropathy grade 3 was 12.7%. Conclusions: Induction chemotherapy whith cisplatin, paclitaxel and capecitabine for three cycles prior to standard treatment offers an effective and safety alternative in patients with locally advanced cervical carcinoma.

scholarly journals P556 Safety and efficacy of ustekinumab in the treatment of Crohn’s Disease: A systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S521-S521
Author(s):  
M Khorshid Fasge ◽  
A Cordie ◽  
S Abd-Elsalam
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Adverse Effects ◽  
Cohort Studies ◽  
Clinical Response ◽  
Observational Studies ◽  
Response Rate ◽  
Meta Analysis ◽  
Clinical Response Rate

Abstract Background This systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment for Crohn’s disease (CD) in clinical trials and observational studies. Methods We retrieved all the related publications from PubMed, Cochrane, EBSCO, Google Scholar and EMBASE using a systematic search strategy. We only included the clinical trials and observational studies that were published in English. Results Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. Twenty-one studies reported the clinical response rate; three of these were clinical trials, and the other 18 were cohort studies. The overall clinical response rate in the cohort studies was 0.539, 95% CI (0.419–0.659) with significant heterogeneity (I2 = 96.22%, P &lt; 0.001) and that in the clinical trials was 0.428, 95% CI (0.356–0.501). The pooled clinical remission rate was 0.399, 95% CI (0.295–0.503) in randomised control trials (RCTs) and 0.440, 95% CI (0.339–0.542) in cohort studies. Twenty-one studies reported the incidence of adverse effects. The rate of adverse effects was 0.158, 95% CI (0.109–0.207) in cohort studies and 0.690, 95% CI (0.633–0.748) in RCTs. Three RCTs had an infection rate of 0.275, 95% CI (0.245–0.295), while the 18 cohort studies had a rate of 0.076, 95% CI (0.047–0.105). Only ten studies reported the incidence of injection or infusion reaction; it was 0.035, 95% CI (0.027–0.043) for RCTs and 0.012, 95% CI (0.002–0.022) for cohort studies. Conclusion Ustekinumab is effective in the treatment of CD. However, more research is required on the safety profiles because there was considerable variation among the included studies.

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