Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.

BACKGROUND AND OBJECTIVES: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures. METHODS: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. RESULTS: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. CONCLUSION: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.

Neonatal meningitis caused by Flavobacterium meningosepticum type F.

Two infants, one premature and one full-term, died from meningitis due to Flav. meningosepticum type F. Careful bacteriological studies are required to prevent possible confusion with other Gram-negative bacilli which may cause meningitis in this age group.

Is there morphological separation between the spinal cord motor nuclei which innervate the heads of a multiheaded muscle?

Horseradish peroxidase was injected into the individual heads of the pectoralis muscles of the dog or applied to the nerve which supplies each of these heads. The location and numbers of labeled motoneurons in the spinal cord were studied using light microscopy. There was longitudinal overlap of the pectoral nuclei, but no separation in their mediolateral or dorsoventral positions. The cutaneous trunci muscle motor nucleus is distinctly separate from the motor nuclei of the pectoral muscles, even though they share a common nerve supply. The methods of horseradish peroxidase application to the cut nerve or injection into the muscle are compared.

Location of the cutaneous trunci motor nucleus in the dog.

Using the methods of muscle injection of horseradish peroxidase (HRP) and application of HRP to the proximal stump of the cut lateral thoracic nerve (LTN), the motor nucleus of the cutaneous trunci muscle (CTM) has been located predominantly in C8 and T1 spinal cord segments in the ventral and ventrolateral nuclei of Rexed's Lamina IX. Cells of the nucleus are somatotopically arranged rostro-caudally to correspond to the rostro-caudal segmentation. There was a higher average number of HRP-filled cells per section and greater rostro-caudal extent of the nucleus for the cut nerve technique than for the muscle injection technique. Evidence is presented that the CTM is an appendicular muscle in spite of its obvious axial position on the trunk.

Omnipaque vs. Hexabrix in intravenous DSA of the carotid arteries: randomized double-blind crossover study.

A randomized double-blind crossover study using Omnipaque 350 mg l/ml (iohexol) and Hexabrix 320 mg l/ml (ioxaglate) in 53 patients undergoing intravenous digital subtraction angiography of the carotid arteries revealed no significant differences in image quality. Some differences were found in subjective side effects that favored Omnipaque. Nausea was reported in four patients after injection of Hexabrix, and a metallic taste was significantly more frequent (p less than 0.01) with this contrast medium. The patients' preference for Omnipaque was also statistically significant (p less than 0.01). It was concluded that both contrast media are suitable for intravenous digital subtraction angiography.

Prognostic variables in patients with prostate cancer: influence of blood group ABO (H), the Rhesus system, age, differentiation, tumour stage and metastases.

Among 279 patients with carcinoma of the prostate no relationship was observed in survival between blood groups ABO (H) or the rhesus system. Age at diagnosis is relevant for the outcome of the disease, but grade of differentiation, tumour stage and metastases are more important predictors of survival.

Empyema of the gallbladder: a case with unusual presentation.

A case of gallbladder empyema associated with multiple complications caused by a delay in diagnosis is presented. Recent literature is reviewed especially emphasizing the clinical presentation with scanty physical signs. Greater awareness of the indolent and chronic presentation might reduce the considerable morbidity and mortality that are associated with delayed operative intervention.

[Treatment principles in urethral stricture in Denmark. A questionnaire study]. / Behandlingsprincipper for urethrastrikturer i Danmark. En enquete.

A questionnaire presented to 79 danish surgical departments showed that about 2,000 urethral strictures are treated in Denmark per annum. These were mainly incised by Sachse's method. 8% of the patients do not have postoperative catheterisation, while the remainder have indwelling catheter from 1-28 days, mainly between 1-3 days. The reasons for the chosen regimes are presented.

[Emergency ultrasonic examinations]. / Akutte ultralydundersøgelser.

The employment and yields of emergency examinations carried out outside normal working hours in Bispebjerg Hospital, Copenhagen, in 1987 are illustrated. This facility is employed particularly by surgical departments for examination of patients with acute abdominal and retroperitoneal conditions and it is frequently supplemented by immediate ultrasonically guided drainage. The possibility of emergency examinations contributed to rapid, certain and gentle diagnosis in the treatment of patients.

[Surgery of penile deviation by Ebbehøj's method]. / Operation for deviatio penis a.m. Ebbehøj.

A questionnaire investigation to evaluate the results of surgery for penile angulation by plicature of tunica albuginea by Ebbehøj's method is presented. In 31 patients with congenital penile angulation, 24 (77%) were satisfied with the functional result and 20 (65%) with the cosmetic result of the operation. In 14 patients with Peyronie's disease, eight (57%) were satisfied with the functional result and six (43%) with the cosmetic result of the operation. This is in accordance with previously published surveys of the results of surgery using this method. However, a high prevalence of late sequelae was observed, especially penile shortening and pain. In conclusion, the method yields acceptable functional and cosmetic results and is easy to perform. However, optimal surgical technique is imperative to reduce the prevalence of late sequelae which also necessitate detailed preoperative information and restrictive indications for surgery.

[Diagnosis and treatment of vesico-intestinal fistula]. / Diagnosticering og behandling af vesikointestinal fistel.

In a retrospective study of 28 patients with vesico-intestinal fistula, the maximal diagnostic latency was eight years. The most common causes were diverticulitis (16 patients) and carcinoma of the colon (4 patients). Recurrent urinary tract infections with pneumaturia and/or faecaluria were found in 23 patients. The diagnosis was most accurately confirmed by cystoscopy and barium enema which showed evidence of a fistula in 20 patients. Patients suffering from diverticulitis were managed with excellent results while surgical intervention in malignancy was associated with brief survival. Diverting colostomy as a sole procedure in patients with infravesical obstruction involves the risk of rectal miction.

[Late postoperative wound infection]. / Sene postoperative sårinfektioner.

In a retrospective study during the last ten years of postoperative wound infections, six cases of late infections were found with a maximum latency of 30 years. A combination of non-absorbable suture materials together with underlying disease seems to have initiated the late formation of wound abscesses. The use of non-absorbable suture seems to involve a life long risk of infection.

[Vasectomy: who regrets it and why?]. / Vasektomi: hvem har fortrudt og hvorfor?

In order to determine the real percentage of sterilised men who regretted their sterilisation and for which reasons, a retrospective questionnaire survey was conducted in 1990-1991 on 244 men sterilised between 1980 and 1983. Information was also collected from their case records. 7.4% of the sterilised men regretted their decision. Of these, 39% were younger than 30, and 94% had started a relation with another woman. The lower age limit for sterilisation according to the law is 25 years, 37% found this age limit too low and 6% found it too high. We conclude that it should be considered whether the legal lower age limit for sterilisation is too low. It is important to thoroughly inform the patient about problems in sexual relations and alternative methods of contraception before he decides on sterilisation.

PIP: During January 1980-February 1983, a total of 421 men were referred to the urological department of Bispebjerg Hospital, Copenhagen, for vasectomy operations, of whom 19 opted out. In 1990, questionnaires were mailed out to 367 of these men. 246 (68%) returned them, but 2 were incomplete, thus a sample was left for analysis of 244 men who had been sterilized 8-10 years before. The inquiry concerned the percentage of regret among them and its causes. 18 (7.4%) regretted their decision, of whom 7 (39%) had been under 30 years of age at the time of operation. In contrast, of the remaining 226 who did not regret it, only 27 (12%) were under 30. A total of 61 (25%) established a new relationship after sterilization. 17 of those who regretted vasectomy had a new relationship, constituting 94% of all those regretting. 37% of the whole sample thought that the legal age limit for sterilization was low, 57% thought it was acceptable, and 6% thought it was too high. At the time of sterilization, 235 (96%) were in steady relationship and 9 were single. 50% of men who regretted their decision and subsequently underwent sterilization reversal operations were under 30 years of age with a median age of 29, compared to 39 years for those regretted it but did not attempt sterilization reversal. The average number of children before sterilization was 2.1, among those regretting it was 2.6, and among those not regretting 2.1. Among the causes of sterilization 210 (86%) cited the desire not to have more children, 120 (49%) cited their relationship, and some referred to the many side effects of oral contraceptives, previous miscarriage, complicated birth, and the desire to have a better sex life. The questions concerning changes in sex life was answered by 77 (32%) as better, 157 (64%) experienced no change, and 10 (4%) said it had become worse. 166 patients (68%) were satisfied with prior instruction from their physician, 161 (66%) from the department, and 217 (89%) had been counseled with at least one case illustration.

[EMLA cream (lidocaine/prilocaine) versus infiltration analgesia with carbocaine (mepivacaine) in vasectomy]. / Emla-creme (lidocain/prilocain) over for infiltrationsanalgesi med Carbocain (mepivacain) ved vasektomi. En randomiseret undersøgelse.

The analgesic efficacy of EMLA cream was compared with infiltration with 1% carbocaine in 13 bilateral vasectomies. Twelve patients preferred infiltration analgesia. EMLA analgesia was only effective in the skin, and had to be supplemented as the incision reached subcutaneous tissue.

Accuracy of distributed multipoles and polarizabilities: comparison between the LoProp and MpProp models.

Localized multipole moments up to the fifth moment as well as localized dipole polarizabilities are calculated with the MpProp and the newly developed LoProp methods for a total of 20 molecules, predominantly derived from amino acids. A comparison of electrostatic potentials calculated from the multipole expansion obtained by the two methods with ab initio results shows that both methods reproduce the electrostatic interaction with an elementary charge with a mean absolute error of approximately 1.5 kJ/mol at contact distance and less than 0.1 kJ/mol at distances 2 A further out when terms up to the octupole moments are included. The polarizabilities are tested with homogenous electric fields and are found to have similar accuracy. The MpProp method gives better multipole moments unless diffuse basis sets are used, whereas LoProp gives better polarizabilities.