Patients’ perspectives after switching from infliximab to biosimilar CT-P13 in patients with inflammatory bowel disease: A 12-month prospective cohort study

BackgroundPatients’ perspectives after switching from infliximab to a biosimilar have yet to be assessed.AimTo assess patients’ perspectives in a prospective manner after switching from infliximab to CT-P13.Methods113 consecutive patients with inflammatory bowel disease (IBD) on maintenance therapy with infliximab were switched to CT-P13. Patients’ perspectives were assessed by questionnaires, including the Beliefs about Medicines Questionnaire (BMQ) and FACIT-F (questionnaire regarding fatigue), and patient-reported outcomes (IBD disability index) at the inclusion and after the fourth CT-P13 infusion.ResultsAfter one year, the patients’ perspectives did not change after the switch according to BMQ-general, BMQ-specific necessity and BMQ-specific concerns subscales. No difference was observed in the mean IBD-DI score, while a significant improvement in fatigue was observed according to the FACIT-F questionnaire. Patients’ concerns were raised about the use of biosimilars and the risks of switching with a significant improvement after switching (65% vs. 42%, respectively, p = 0.01). Fourteen (12.4%) patients experienced loss of response to CT-P13, including 12 with restoration of steroid-free clinical remission after CT-P13 dose optimization.ConclusionAlthough some concerns were reported, no difference was observed in patients’ perspectives after switching from infliximab to CT-P13.     

New technique of aortic root reconstruction with aortic valve annuloplasty in ascending aortic aneurysm

We describe a new technique of aortic valve conservation for ascending aortic aneurysm with aortic valvular insufficiency. This technique allows a total anatomic aortic root reconstruction associated with an aortic annuloplasty preventing late annulus dilation and reoperation. Preliminary results demonstrate the feasibility and the safety of this new original procedure.     

Stents for palliation of obstructive metastatic colon cancer: impact on management and chemotherapy administration

HYPOTHESIS: The more rapid and less complicated recovery after palliative stent insertion compared with surgery may theoretically facilitate the early administration of chemotherapy. DESIGN: A retrospective study. SETTING: University tertiary care referral center. PATIENTS: From January 1, 1996, to September 15, 2005, 58 patients with obstructing colon cancer and nonresectable synchronous metastases were treated with self-expanding colonic metallic stent (SEMS) (n = 31) or surgery (n = 27). MAIN OUTCOME MEASURES: Comparison of the use of SEMS and emergency surgery as palliative measures to treat obstructing colon cancer with special reference to time to chemotherapy administration and survival. RESULTS: Mortality and morbidity were comparable between the 2 groups. Median hospital stay was shorter after SEMS insertion than after surgery (median, 8.0 vs 13.5 days, respectively; P < .01). Incidence of stoma creation was lower in patients treated with SEMS than in patients treated with surgery (6% vs 37%, respectively; P = .02). The median time to chemotherapy administration was shorter after SEMS insertion than after surgery (14.0 vs 28.5 days, respectively; P = .002). Three patients with SEMS and 0 patients in the surgical group underwent a curative colonic and hepatic resection after downstaging by chemotherapy (P = .27). Two patients (6%) with SEMS and undergoing chemotherapy had a tumor perforation requiring emergency surgery. There was no difference in survival between the 2 groups (median survival, 13.7 months for SEMS vs 11.4 months for surgery; P = .19). CONCLUSIONS: Insertion of SEMS should be the first step to treat obstructing colon cancer with nonresectable synchronous metastases because it allows chemotherapy to be administered earlier, may increase the resectability rate of metastases, and favorably impacts survival. The risk of tumor perforation while receiving chemotherapy requires attention.     

Detection of neuroendocrine tumors: 99mTc-P829 scintigraphy compared with 111In-pentetreotide scintigraphy.

The aim of this study was to evaluate the diagnostic value of a new somatostatin analog, 99mTc-P829, compared with that of 111In-pentetreotide. METHODS: Forty-three patients (32 men, 11 women; age range, 24-78 y; mean age, 56 y) with biologically or histologically proven neuroendocrine tumors were prospectively included: 11 patients with Zollinger-Ellison syndrome, 16 patients with carcinoid tumors, and 16 patients with other types of functioning (n = 6) or nonfunctioning (n = 10) endocrine tumors. 111In-Pentetreotide planar images (head, chest, abdomen, and pelvis) were obtained 4 and 24 h after injection of 10 microg somatostatin analog labeled with 148 +/- 17 MBq 111In, and SPECT was performed 24 h after injection. Similar (99m)Tc-P829 planar images were obtained at 1, 4-6, and 24 h after injection of 50 microg peptide labeled with 991.6 +/- 187.59 MBq 99mTc. Abdominal SPECT was performed 4-6 h after injection. RESULTS: 111In-Pentetreotide detected 203 tumoral sites in 39 (91%) of 43 patients, whereas 99mTc-P829 detected 77 sites in 28 (65%) of 43 patients (P < 0.005). In the liver, 129 sites (in 24 patients) were detected by 111In-pentetreotide scintigraphy and 34 sites (in 10 patients) were detected by 99mTc-P829 scintigraphy. CONCLUSION: In patients with endocrine tumors, the detection rate of 99mTc-P829 scintigraphy was lower than that of 111In-pentetreotide scintigraphy, which appeared to be more sensitive, especially for liver metastases.     

Prevalence of patent foramen ovale and usefulness of percutaneous closure device in carcinoid heart disease

The aim of this study was to assess (1) the incidence of patent foramen ovale (PFO) in carcinoid syndrome (CS) and (2) the feasibility of percutaneous closure procedure in selected patients with CS. One hundred eight patients were prospectively studied: 54 with CS and an age- and gender-matched control group. All patients underwent conventional and contrast echocardiography. Patients with clinical signs of dyspnea (New York Heart Association class > or =III), cyanosis, carcinoid heart disease (CHD), and severe PFO were referred for the percutaneous closure of PFO. The prevalence of PFO was 41% in patients with CS and 22% in the control group (p = 0.03) and was significantly higher in patients with CHD (59%, p = 0.009). Four patients (14% of those with CHD) were referred for the percutaneous closure of PFO, and 3 patients ultimately underwent PFO closure (using Amplatzer septal occluders). At 6-month follow-up, New York Heart Association class was improved in all patients, as well as arterial blood gas results (p = 0.04) and 6-minute walking distance (p = 0.03), but all patients presented residual right-to-left shunts. In conclusion, this prospective study demonstrates that in patients with CHD, the prevalence of PFO is high and that percutaneous closure of PFO is feasible, with a reduction in symptoms but with residual shunting.     

Mitral annulus calcification: determinants of repair feasibility, early and late surgical outcome.

OBJECTIVE: The aim of this study was to determine the factors influencing the feasibility of valve repair and the surgical outcome in patients with mitral annulus calcification. METHODS: In 124 patients with mitral annulus calcification undergoing surgery, two entities were distinguished: Barlow disease (myxomatous leaflets, n=60) and fibroelastic deficiency (FED) (normal leaflets, n=64). The calcification score was lower (1.9 vs 2.8); the annulus was more dilated (ring 35 vs 32 mm) and ruptured chordae were more frequent (77% vs 37%) in Barlow than in FED (p<0.001). The clinical profile was different: age (60+/-14 vs 73+/-8 years, p<0.001), systemic hypertension (22% vs 70%, p<0.001), chronic renal insufficiency (5% vs 22%, p<0.01), cancer (7% vs 25%, p<0.01). Multifocal atherosclerosis was less frequent in Barlow than in FED: carotid disease (17% vs 54%, p<0.001), aortic atheroma (21% vs 51%, p<0.001) and coronary disease (22% vs 56%, p<0.01). Echocardiography showed two different patterns in Barlow and FED: aortic valve stenosis (1.7% vs 31%), left atrial diameter (54 vs 49 mm), left ventricular end-diastolic diameter (62 vs 54 mm), interventricular septal thickness (11 vs 13 mm), and systolic pulmonary pressure (40 vs 56 mmHg), respectively (p<0.001). Bacterial endocarditis was observed in 24 cases (19%). RESULTS: The surgical technique was a valve repair in 68% and a replacement in 32%. The repair rate depended upon the extent of annulus calcifications (p<0.001) and the type of degenerative disease (95% vs 44% in Barlow and FED p<0.001). In-hospital mortality was 14% (Barlow: 5% vs FED: 23%, p<0.01). The mean follow-up was 50+/-41 months. Overall 5-year year survival was 76% (Barlow: 90% vs FED: 64%, p<0.001) and survival free from cardiac event was 69% at 5 years (Barlow: 87% vs FED: 52%, p<0.001). Five-year survival was higher following repair than replacement (84% vs 64% p<0.001). Chronic renal insufficiency and bacterial endocarditis were two predictors of early and late death (p<0.01). CONCLUSIONS: The aetiopathogeny of the degenerative mitral disease responsible for annulus calcifications corresponded to distinct anatomical, clinical and echographic patterns. It was a main determinant of repair feasibility, early and late surgical outcome.