Background and objectivesThe 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.MethodsPatients 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.ResultsBaseline 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.ConclusionThe 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.

Maternal training during pregnancy has been the subject for numerous investigations lately, which are presented in this survey. No studies in human beings have shown any negative effect of training on the embryogenesis. During physical training a small rise in foetal heart rate of 5-25 bpm is a common finding. This could be due to a reduction in oxygen delivery or more likely stimulation from maternal vasoactive hormones or training-induced uterine contractions. Foetal growth seems to be influenced by maternal activity, as some investigations have found significantly bigger babies born by moderately trained females compared to non-trained or heavily trained women. In the latter group the reduction could be explained by a reduced neonatal fat mass. Increased maternal temperature during training has not been found to lead to any foetal abnormalities. The results indicate that moderate training during pregnancy can be recommended with observance of simple directives.

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All eight production workers from a small trout-processing factory were studied because of respiratory or rhinitis symptoms when working next to the automatic gutting machine. Seven of the eight had positive histamine provocation tests. Four patients had elevated total IgE levels while one had a slightly elevated eosinophil count. All workers had either weakly or moderately positive RAST against contaminated water from the outlet drain of the gutting machine. This water contained 1 microgram endotoxin/ml. We concluded that five of the workers had probably developed occupationally related asthma from inhalation of contaminated aerosol from the gutting machine. Inhalation of endotoxin from gram-negative bacteria may be the cause of this disorder. An alternative explanation is a Type I allergy caused by fish or bacterial protein with or without a simultaneous effect of endotoxin.