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1.
J Intern Med ; 285(6): 653-669, 2019 06.
Article in English | MEDLINE | ID: mdl-30762274

ABSTRACT

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.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Arthritis/drug therapy , Colitis, Ulcerative/drug therapy , Infliximab/therapeutic use , Psoriasis/drug therapy , Adult , Antibodies, Monoclonal/adverse effects , Double-Blind Method , Drug Substitution , Female , Humans , Male , Middle Aged , Norway , Time Factors , Treatment Outcome
2.
J Int Med Res ; 9(3): 181-5, 1981.
Article in English | MEDLINE | ID: mdl-7016626

ABSTRACT

The rate of side-effects should today be more important for the choice of an agent for treatment of acute urinary tract infections than the cure rate, as this usually is above 90%. The side effects with co-trimoxazole (trimethoprim-sulphamethoxazol) have been viewed as caused mainly by the sulphonamide component. In this randomized, double-blind trial Group A has been treated with trimethoprim 200 mg x 2 and Group B with nitrofurantoin 50 mg x 4 for a duration of 10 days. There was no difference in cure rate between the two groups. The rate of side-effects was 26% in Group A and 12% in Group B. In Group A 12% had skin eruptions, mostly appearing on Day 7 or later, in Group B 1.3% had eruptions. These differences are statistically significant (p less than 0.05). This result, together with a survey of the literature, indicates that the frequency of these rashes might be related both to dosage and duration of treatment. The origin of the side-effects caused by co-trimoxazole should be reconsidered. The in vitro sensitivity against trimethoprim and nitrofurantoin was tested using a disc diffusion method in 98 infecting strains from patients in this study. Two per cent were resistant against trimethoprim and 81% against nitrofurantoin. We found no correlation between the size of the inhibition zone and bacteriological cure rate. This makes the value of the disc diffusion method in out-patients with acute urinary tract infections questionable.


Subject(s)
Bacterial Infections/drug therapy , Nitrofurantoin/therapeutic use , Trimethoprim/therapeutic use , Urinary Tract Infections/drug therapy , Adolescent , Adult , Aged , Clinical Trials as Topic , Double-Blind Method , Female , Humans , In Vitro Techniques , Male , Middle Aged , Nitrofurantoin/adverse effects , Trimethoprim/adverse effects
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