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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.

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In this study we report the differences in distribution and retention of Aeromonas salmonicida antigens after vaccination with two different vaccines. Parr of Atlantic salmon (Salmo salar) were given intraperitoneal injections of either a commercial, monovalent furunculosis vaccine (Apoject) or live, attenuated A. salmonicida (DeltaaroA). Fish were sampled at weeks 2, 4 and 12 post-vaccination and head kidney and spleen were collected. Presence of LPS and 16S rDNA in isolated leukocytes were investigated by immunocytochemistry and polymerase chain reaction (PCR).16S rDNA was detected in head kidney and spleen of all DeltaaroA vaccinated and most Apoject-vaccinated fish at weeks 2 and 4. At week 12, 16S rDNA was detected in none of the DeltaaroA vaccinated fish, but it was detected in head kidney of 75% of Apoject-vaccinated fish. LPS was detected in both vaccination groups at all sampling times, but most frequently in the DeltaaroA vaccinated fish (in head kidney 75-83% vs. 50%, in spleen 58-67% vs. 17-25%).

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Body malformation due to shortness of the vertebral column, in most cases of unknown cause, has been observed in fish for more than 100 yr. It periodically occurs with high prevalence in farmed Atlantic salmon Salmo salar in Norway, and this paper describes the results of macroscopic, radiographic and histologic examination of parr and seawater-transferred fish. The vertebral bodies in both age groups did not acquire the length that they normally should due to a growth disturbance leading to the condition of platyspondyly and shortness in the column. The pathologic changes became visible at different ages in both groups and the process apparently starts in intervertebral tissues. There was proliferation of connective tissue and blood vessels, and sometimes infiltration with inflammatory cells, around affected vertebrae, especially in seawater-transferred fish. This is the first description of inflammation in abnormally short-spined fish, and it may indicate an infectious etiology, at least in farmed seawater-transferred salmon.

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Two hundred and five isolates of atypical Aeromonas salmonicida, recovered from a wide range of hosts and countries were characterized by polymerase chain reaction (PCR) targeting four genes. The chosen genes were those encoding the extracellular A-layer protein (AP), the serine protease (Sprot), the glycerophospholipid:cholestrol acetyltransferase protein (GCAT), and the 16S rRNA (16S rDNA). All the atypical A. salmonicida isolates could be assigned to 4 PCR groups. Group 1 comprised 45 strains which tested positive for PCR amplification, using the 16S rDNA, GCAT2, Sprot2, and AP primer-sets. Group 2 comprised 88 strains with produced PCR products using the 16S rDNA, GCAT2 and AP primer-sets. Group 3 comprised 21 strains which produced PCR products using 16S rDNA, GCAT2 and Sprot2 primer-sets, and group 4 comprised 51 strains which produced PCR products using the 16S rDNA and GCAT2 primer-sets only. A. salmonicida subsp. salmonicida isolates tested, belonged to group 1. The PCR primer-sets separated A. salmonicida from other reference strains of Aeromonas species and related bacteria with the exception of Aeromonas hydrophila. The results indicated that PCR typing is a useful framework for characterization of the increasing number of isolations of atypical A. salmonicida.

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Fifty two isolates of atypical Aeromonas salmonicida, recovered from a wide range of hosts and geographical locations, were heterogeneous in terms of molecular and phenotypic characteristics, and represented taxa which could not be accommodated by the current classification of four subspecies. Generally, there was incongruence between the molecular (PCR, RAPD and ribotyping) and phenotypic methods in terms of cluster membership. By PCR, 6 groups were described of which Group 1 encompassed 12 isolates including the type strain of A. salmonicida subsp. smithia. Group 2 accommodated 23 isolates including the reference cultures of subspecies achromogenes and masoucida. The named culture of Haemophilus piscium was recovered in Group 6. By ribotyping and RAPD, the reference cultures were recovered in separate groups. All methods pointed to the uniqueness of subspecies smithia. Most isolates contained 2-6 plasmids, of 2.3 to 150 kb in length. Nevertheless, all isolates possessed certain key characteristics, including Gram-negativity, and the absence of motility.

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The atypical isolates of Aeromonas salmonicida are becoming increasingly important as the frequency of isolation of bacteria belonging to this group continues to rise. The primary object of this study was to compare and evaluate the results obtained in various laboratories concerning the biochemical identification of atypical Aer. salmonicida before and after standardization of media and methods. Five laboratories examined 25 isolates of Aer. salmonicida from diverse fish species and geographical locations including the reference strains of Aer. salmonicida subsp. salmonicida (NCMB 1102) and Aer. salmonicida subsp. achromogenes (NCMB 1110). Without standardization of the methods, 100% agreement was obtained only for two tests: motility and ornithine decarboxylase. The main reason for the discrepancies found was the variation of the incubation time prior to reading the biochemical reactions. After standardization, improvement was obtained with the identification; however, disagreement was still observed between the different laboratories. These findings demonstrate the difficulties involved in a proper identification of atypical Aer. salmonicida and also that data presented in the literature on various strains of Aer. salmonicida are not readily comparable. This paper seems to be the first on standardization of microbiological tests for identification of fish pathogens and the results obtained show the need for standardization of methods both within and between laboratories.

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Twenty one isolates of Streptococcus suis were screened for antibiotic resistance by growth on antibiotic-containing media, by measuring minimum inhibitory concentrations, by hybridization to specific DNA and oligonucleotide probes for antibiotic resistance genes, and by PCR. The isolates were from a slaughter house survey of respiratory pathogens in Norwegian pigs in 1986. Fifteen isolates were resistant to tetracycline, with MICs ranging from 4-128 micrograms/ml. Genes coding for the Tet O and Tet M determinants were detected in eight and five isolates, respectively. Genes coding for other Gram positive Tet determinants, Tet K, Tet L, and Tet P, were not detected. One isolate was constitutive resistant to erythromycin with MIC of 128 micrograms/ml. Five other isolates carried inducible erythromycin resistance. All these isolates, and five others, were positive in a PCR assay for erythromycin resistance, and hybridized with the Erm C and/or Erm B probes. No resistance against chloramphenicol (5 micrograms/ml) or rifampin (10 micrograms/ml) could be could be detected, but five isolates were resistant to streptomycin (250 micrograms/ml), four isolates were resistant to kanamycin (10 micrograms/ml), and one isolate was resistant to fusicic acid (10 micrograms/ml). In mating experiments with Enterococcus faecalis JH2-2 as recipient, tetracycline, erythromycin, and kanamycin genes were transferred separately to the recipient strain at a rate of 10(-7) transconjugants/recipient cell.

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A total of 855 pig lungs were collected at slaughter and evaluated macroscopically. Bacteriological examinations were carried out on tissue samples from chronic pleuropneumonic lesions (n = 196) and from chronic bronchopneumonic lesions with suppuration (n = 14). Samples from normal lung tissue (n = 22) were also included. Pasteurella multocida was isolated from 54%, Actinobacillus (Haemophilus) pleuropneumoniae from 11%, and Streptococcus spp. from 14% of the pneumonic lesions, respectively. From normal lung tissue P. multocida was isolated from 3 (14%) of the samples, A. pleuropneumoniae was not recovered and streptococci were isolated from only 1 (5%) of these samples. The above mentioned bacterial species were recovered either in pure cultures or mixed with various other microbes. A total of 109 P. multocida strains were further characterized by capsular serotyping and testing for production of dermonecrotic toxin. Ninety-nine (91%) of the strains were capsular type A 10 (9%) were type D. Out of the type A and the type D strains 94% and 90% were toxigenic, respectively. Most of the A. pleuropneumoniae strains were serotype 2. Strains of serotypes 1 and 7 were also identified. The majority of the streptococci were identified as either Streptococcus suis or Streptococcus dysgalactiae. Actinomyces pyogenes was isolated from 14% of the lesions and anaerobic bacteria from 18%, respectively. The significance of the various bacterial species in relation to the development of chronic pneumonic lesions is discussed. Special attention is paid to P. multocida, and it is concluded that this bacterial species is probably of importance for the development of both types of chronic pneumonias.

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Lungs from 191 slaughter pigs with gross lesions indicative of enzootic pneumonia of pigs (EPP) and 80 grossly normal lungs, all originating from 9 different herds, were subjected to microbiological and pathological examinations. The microbiological studies included both bacterial and mycoplasmal culture and also testing for Mycoplasma hyopneumoniae antigen in tissue by indirect immunofluorescent technique. M. hyopneumoniae, Pasteurella multocida and Mycoplasma hyorhinis were detected in 83%, 43% and 37% of the pneumonic lungs, respectively. Mycoplasma flocculare was the most frequently isolated organism in the non-pneumonic lungs. The greatest amounts of macroscopic pneumonia (25.2%) were recorded in lungs with all the three agents M. hyopneumoniae, P. multocida and M. hyorhinis present. The amounts of pneumonia in lungs with M. hyopneumoniae alone and in concurrence with P. multocida, were 9.3% and 15.6%, respectively. M. hyorhinis was also, in this study, associated with higher frequency of diffuse pleuritis. These findings indicate that M. hyorhinis might be involved in the pathogenesis of pneumonia in slaughter pigs. Ninety-six per cent of the isolates of P. multocida from pneumonic lungs could be characterized as type A. In the herds which had the most severe pneumonia problems, toxin production was detected in 83% of the P. multocida strains while only 28% were toxigenic in herds with subclinical to moderate pneumonia problems.

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When small amounts of DNase produced by Staphylococcus aureus, S. intermedius or S. hyicus were added to Toluidine Blue DNA Agar (TDA), a medium for demonstration of staphylococcal antiDNases was produced. By applying this medium in microtitre plates, a test system for titration of staphylococcal antibodies in serum samples was developed. A colour change from blue to pink could be observed when the DNase was allowed to act, i.e. when no staphylococcal antiDNases were present in the samples. When serum with neutralizing antibodies were applied, no colour change developed. An end-point could easily be demonstrated in dilutions of the serum. A description of the method, including certain of its limitations is given.

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An agar diffusion method using microtiter plates was used to detect antibodies to the DNases produced by Staphylococcus aureus, S. intermedius, and S. hyicus. Antibodies to DNase from S. aureus were demonstrated in most of the sera from the species investigated, except dogs, only 11% of whose sera were positive. Positive titers to S. intermedius DNase were found in 84% of deg sera, 61% of Icelandic pony sera, 41% of pig sera, 21% of human sera, and 20% of cow sera but in only 2 and 4% of goat and sheep sera, respectively. Although antibodies to DNase from S. hyicus were not found in sera from humans, dogs, goats, or sheep, 84% of sera from pigs and cows and 29% of sera from Icelandic ponies were positive in this respect. The good accordance between the findings from bacteriological investigations performed elsewhere and the results of serologic tests performed in this study indicates that the results obtained with the serological method in this study properly reflect the actual antigenic exposure to and distribution of the three Staphylococcus spp. in animals and humans.

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