A Patients' Perspective Towards the Injection Devices for Humira® and Imraldi® in a Nationwide Switching Program.

OBJECTIVE: Due to a tender process in Iceland, all patients on Humira® were switched nationwide to its biosimilar Imraldi® in March 2019. The study aimed to explore the patient's perspective of the Humira® and Imraldi® injection devices. METHODS: A standard telephone interview was carried out among patients with inflammatory arthritis, inflammatory bowel disease and psoriasis, who underwent this nationwide switching program a few months earlier. RESULTS: The response rate was 84.5% (n = 198). The average age was 50.8 years, and 53.5% were female. The patients self-administered the drugs in 96% of the cases. The majority (90.5%) stated that they received individualized instruction on using the Humira® pen, compared to 18.2% who accepted instruction in the case of the Imraldi® pen. Almost half (46.6%) of the patients found it more difficult to use the Imraldi® pen than the Humira® pen, while only 12.5% found the Imraldi® pen easier to use. Firstly, these differences were due to more painful insertion of the needle (62.2%) and secondly, due to the experience, the injection process was different (63.0%). CONCLUSION: Patients with inflammatory disorders who have been treated regularly with adalimumab preferred the Humira® injection device over the Imraldi® device, according to our results. After all, these injection devices' structure and content are not the same, although both contain the same active ingredient, i.e. adalimumab. Our results highlight the importance of thorough information, not only with an information letter but also with the possibilities for individualized introduction in planning switching to biosimilars.

The majority of patients with psoriatic arthritis are not eligible for randomised clinical trials.

OBJECTIVES: To identify the proportion of patients with psoriatic arthritis (PsA) who would meet inclusion criteria of the randomised clinical trials that were performed leading up to registration of the tumour necrosis factor inhibitors (TNFi). METHODS: Data from 329 patients with PsA were obtained from an Icelandic database, ICEBIO, medical records at the University Hospital of Iceland, and the private out-patient clinic Laeknasetrid Ltd. The patients were classified according to whether they met the inclusion criteria of the clinical trials that were performed ahead of the registration of each respective TNFi. The reasons for exclusion were also explored. RESULTS: 34% of the patients with complete data available met the inclusion criteria. Clinical data in respect to exclusion and inclusion criteria were incomplete for 13% of the cases. The proportion of patients who met the inclusion criteria was highest among those who received adalimumab and etanercept (53%). Patients who received in iximab had the lowest inclusion rate (23%). The main reason why patients did not meet the inclusion criteria was too few swollen and/or tender joints, or in 45% of excluded cases. CONCLUSIONS: Our results demonstrate that two thirds of patients with PsA in Iceland who are treated with TNFi would not have qualified for the randomised clinical trials performed leading up to the registration of the medications. Further studies with regards to whether outcomes are different between those who met the inclusion criteria and those who did not remain to be performed.

Factors that influence prescribers in their selection and use of COX-2 selective inhibitors as opposed to non-selective NSAIDs.

OBJECTIVE: To identify factors that influence prescribers in their selection and use of cyclo-oxygenase-2 (COX-2) selective inhibitors as opposed to non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and report the tendency to co-prescribe gastro-protection with these agents. SETTING: All 579 general practitioners (GPs) in one geographical area, Lothian, Scotland, UK. METHOD: Postal questionnaires; simple and factorial designed case series questionnaire. MAIN OUTCOME MEASURES: Categorisation of responses to clinical and non-clinical factors into highly, partially or not influential. The quantitative influence of the most prominent clinical factors on prescribing choice and the tendency of co-prescription of gastro-protection with these agents. RESULTS: Responses from 229 (40%) GPs suggested the following as most influential: Drug Evaluation Panel recommendations, Lothian Joint Formulary, local practice formulary, history of peptic ulcer disease (PUD), history of gastro-intestinal (GI) adverse effects with NSAIDs and advanced age. Advice from other physicians, patient demand, history of alcohol gastritis, history of gastro-oesophageal reflux disease, history of functional dyspepsia, concomitant use of low dose aspirin and concomitant use of gastro-protective agents were regarded to have moderate influence. Information directly from pharmaceutical industry and regular smoking were regarded as having weak influence. An 18% response to the factorial designed questionnaire using the most prominent clinical factors suggested that history of either GI adverse effects associated with non-selective NSAIDs or PUD resulted in more pronounced increase in the frequency (15%) of decision to prescribe COX-2 selective inhibitors than advanced age (10%). Concomitant use of low dose aspirin had little effect on GPs' decisions. The mean percentage of GPs choosing to co-prescribe gastro-protection was higher with non-selective NSAIDs (64%) than with COX-2 selective inhibitors (22%). CONCLUSION: Local authoritative guidance and history of GI complications highly influenced the GPs in their use and choice of either COX-2 selective inhibitors or non-selective NSAIDs. As expected the use of gastro-protection was more frequently chosen with non-selective NSAIDs than COX-2 selective inhibitors.