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.

Treatment use and satisfaction among patients with psoriasis and psoriatic arthritis: results from the NORdic PAtient survey of Psoriasis and Psoriatic arthritis (NORPAPP).

BACKGROUND: There are scarce data in Scandinavia about treatment satisfaction among patients with psoriasis (PsO) and/or psoriatic arthritis (PsA). The number of patients receiving systemic treatment is unknown. OBJECTIVE: To describe patients' experience of treatments for PsO/PsA in Sweden, Denmark and Norway, addressing communication with physicians, satisfaction with treatment and concerns regarding treatment options. METHODS: The NORdic PAtient survey of Psoriasis and Psoriatic arthritis (NORPAPP) asked 22 050 adults (randomly selected from the YouGov panels in Sweden, Denmark and Norway) whether they had PsO/PsA. A total of 1264 individuals who reported physician-diagnosed PsO/PsA were invited to participate in the full survey; 96.6% responded positively. RESULTS: Systemic treatment use was reported by 14.6% (biologic: 8.1%) of respondents with PsO only and by 58.5% (biologic: 31.8%) of respondents with PsA. Biologic treatments were more frequently reported by respondents considering their disease severe (26.8% vs 6.7% non-severe) and those who were members of patient organizations (40.7% vs 6.9% non-members). Discussing systemic treatments with their physician was reported significantly more frequently by respondents with PsA, those perceiving their disease as severe (although 35.2% had never discussed systemic treatment with their physician) and those reporting being a member of a patient organization (P < 0.05). Many respondents reported health risk concerns and dissatisfaction with their treatment. Of special interest was that respondents aged 45-75 years reported less experience with biologics (8.1%) than those aged 18-44 years (21.5%). The older respondents also reported more uncertainty regarding long-term health risks related to systemic treatments (most [66.7-72.9%] responded 'do not know' when asked about the risk of systemic options). CONCLUSION: It appears likely that substantial numbers of Scandinavians suffering from severe PsO/PsA are not receiving optimal treatment from a patient perspective, particularly older patients. Also, one-third of respondents with severe symptoms had never discussed systemic treatment with a physician.

Quality of life and contact with healthcare systems among patients with psoriasis and psoriatic arthritis: results from the NORdic PAtient survey of Psoriasis and Psoriatic arthritis (NORPAPP).

Psoriasis (skin psoriasis, PsO) is a chronic inflammatory condition. In about one-third of cases, the joints are affected (psoriatic arthritis, PsA). Both conditions, especially PsA, profoundly impact patients' health-related quality of life (HRQoL). To describe the impact of psoriasis on HRQoL and patients' contact with the healthcare system in Sweden, Denmark, and Norway, the NORdic PAtient survey of Psoriasis and Psoriatic arthritis (NORPAPP) asked 22,050 adults randomly selected in Sweden, Denmark and Norway if they had psoriasis. 1264 individuals who reported physician-diagnosed PsO/PsA were invited to the full survey; 1221 responded (74.6% diagnosed with PsO alone; 25.4% with PsA ± PsO). Respondents with PsA most frequently consulted a rheumatologist; however, 14.3% had never seen a rheumatologist. Respondents with PsO alone most frequently consulted a general practitioner and 10.7% had never seen a dermatologist (although those with severe symptoms visited dermatologists more often). Negative impacts on HRQoL were reported by 38.1% of respondents with PsO [mostly limitations on clothing (22.6%), sleep disorders (16%), and depression/anxiety (16%)] and by 73% of respondents with PsA [mostly limitations on clothing (41.8%), sports/leisure (44.0%), or daily routine (45.1%) and sleeping disorders]. Absence from work/education was more common with PsA ± PsO (51.9%) than PsO alone (15.1%). In this survey in Sweden, Denmark, and Norway, the impact of psoriasis on the respondents' HRQoL was profound and was greater for PsA than for PsO, as was sickness absence. Sleeping disorders and depression were common and should not be overlooked.

Casual sexual experience abroad in patients attending an STD clinic and at high risk for HIV infection.

OBJECTIVE: To study possible "import" routes of HIV infection to Norway (by obtaining information on casual sexual contacts abroad from patients attending an STD clinic), and to assess their behavioural risk factors (such as alcohol intake, use of condom) for HIV infection. DESIGN AND SETTING: Patients visiting the clinic for sexually transmitted diseases (STD), April-June 1989, received a questionnaire. SUBJECTS: 606 consecutive persons of whom 599 agreed (98.8%) to participate. We grouped the patients in four categories. 1: Sex with a prostitute during the last 5 years, 2: Homosexuals/bisexuals, 3: prostitutes/intravenous drug abusers (IVDUs) and 4: Other heterosexuals. RESULTS: 245 patients (41%) reported having a casual sex partner abroad (M: 182, F: 63), mainly in Europe, particularly in Spain, Denmark and Greece. Outside Europe such contacts were most frequently reported from USA, Brazil and Thailand. Among men who had had sex with a prostitute, 93.5% reported such sex abroad (homosexuals/bisexuals: 63.6%, prostitutes/IVDUs: 66.7%, "other heterosexuals: 32.1%). Homosexual/bisexual men with casual partner(s) abroad used a condom more frequently than did others. CONCLUSION: 245 of 599 persons reported casual sex abroad during 1985-1989, and the different "risk groups" reported countries where most HIV infected persons belonged to their own "risk group". We have reason to believe that alcohol intake increased the likelihood of casual sexual activity and decreased the use of condom. Norwegian travellers need more information on the risks of casual sex abroad, the use of condoms and the combination of alcohol intake and casual sex.

Casual sex, extramarital sex, condom use and alcohol intake among heterosexual patients attending an STD clinic in Norway.

A study excluding homosexuals was performed to study casual sex, extramarital sex, the use of a condom with a casual sexual partner and the combination of alcohol intake and casual sex among patients attending a clinic for sexually transmitted diseases (STDs). Heterosexual patients (467) received a questionnaire, and 458 were included. Men reported more (94%) casual sexual partners than did women (76%). According to a multiple logistic regression analysis a condom was used significantly less frequently in "old" respondents, those having a permanent sexual partner, those having low education, those infected with STDs (earlier STDs), those who had had more than 4 sexual partners over the last year, and those combining alcohol intake and casual sex. Intravenous drug users/prostitutes used a condom more often than did men with paid sex and "other heterosexuals". To have an effect on STD patients, innovative forms of health education may be necessary, and greater emphasis should be placed on more informal means of information, including interactive health education and communication strategies to promote positive attitudes regarding condom use.

PIP: This study examined casual sex, extramarital sex, the use of a condom with a casual sexual partner, and the combination of alcohol intake and casual sex among heterosexual patients attending a sexually transmitted disease (STD) clinic. 467 patients received a questionnaire, and 458 were included in the study. Men reported casual sex more frequently than did women (94% and 76%, respectively). According to a multiple logistic regression analysis a condom was used significantly less frequently in "old" respondents, those having a permanent sexual partner, those having low education, those infected with STDs (earlier STDs), those who had had more than 4 sexual partners over the last year, and those combining alcohol intake and casual sex. Intravenous drug users/prostitutes used a condom more often than did men with paid sex and "other heterosexuals". To have an effect on STD patients, innovative forms of health education may be necessary, and greater emphasis should be placed on more informal means of information, including interactive health education and communication strategies to promote positive attitudes regarding condom use.

Knowledge of HIV infection and the fear of mixing socially with HIV-infected and AIDS-sick patients among STD patients in Bergen, Norway.

This is a study of data from 599 STD (sexually transmitted disease) clinic patients in Bergen, Norway who visited the clinic in April-June 1989. We studied the patients' knowledge of modes of HIV transmission and their degree of ignorance of how HIV is not transmitted. Particular interest was focused on how misconceptions influenced the respondents' perception of HIV/AIDS sick persons and the importance of confidence in AIDS information from the health authorities. The objective of the study was to compare the data from this investigation of STD patients with data from similar studies in the general public conducted in Norway between 1986 and 1991. HIV-infected blood (98.3%; 589/599) and unprotected vaginal intercourse (91%; 545/599) were frequently suggested as a mode of HIV transmission, while 22.4% (134/599) did not recognize anal sex as an unsafe sexual practice. There was no statistically significant difference in their knowledge of modes of HIV transmission between the following patient subgroups: homosexuals/bisexuals, intravenous drug users (IVDUs)/prostitutes, sex customers and respondents classified as 'other heterosexuals'. Regarding ways in which HIV is not transmitted, ignorance was first and foremost related to whether the HIV virus could be passed on by oral kissing (wrong: 38.5%). Knowledge of how HIV is not transmitted was positively correlated with education (p < 0.05) and confidence in the HIV/AIDS information from health authorities (p < 0.05), and negatively correlated with age (p < 0.05). Respondents knowing how HIV is not transmitted considered social contact with HIV/AIDS sick persons to be harmless (p < 0.001). The present information campaigns on HIV/AIDS have been less effective than expected. In the future we must find new ways of informing the public by identifying the essential components that are missing from the information campaigns we have today.

HIV-seropositive rate and HIV test activity among STD clinic attendees in Bergen, Norway.

We wanted to determine the HIV seropositive rate and to study the connection between previous HIV testing, acceptance of HIV testing and sexual behaviour among STD clinic patients in Bergen, Norway. Patients attending the STD clinic in 1986-93 requesting HIV testing were registered, and all patients visiting the clinic in April-June 1989 received a questionnaire and were asked if they wanted to be HIV tested. The overall HIV seropositive rate was 0.4% (14/3805); in homo-/bisexual men: 2.9% (8/278); IVDUs: 0.4% (1/236) and in heterosexual non-IVDUs: 0.2% (5/3291). Among the 599 individuals offered anonymous HIV testing, 42.2% were HIV tested and 69.2% did not object to HIV-testing. IVDUs/prostitutes (p < 0.001), customers of prostitutes (p < 0.001), homo-/bisexuals (p < 0.01), and patients receiving blood transfusion (p < 0.005) had all been HIV tested more frequently than 'other heterosexuals'. Respondents reporting casual sex, casual sex abroad, infection with STDs, and a greater number of partners were more frequently HIV tested and also accepted HIV testing more frequently than respondents without such behaviour, indicating that there is some rationale behind the decision to be tested.