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Aim: PIONEER REAL Canada examined real‐world clinical outcomes associated with the use of once‐daily oral semaglutide in adults with type 2 diabetes. Materials and Methods: This was a 34‐ to 44‐week, multicentre, prospective, open‐label, non‐interventional study in adults who were treatment‐naive to injectable glucose‐lowering medication and initiated oral semaglutide in routine clinical practice. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to the end of the study (EoS). Secondary endpoints assessed at EoS were change from baseline in body weight (BW); the proportion of participants reaching HbA1c levels <7% and the composite endpoints, HbA1c reduction ≥1% point with BW reduction ≥3% and ≥5%; and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status and change. Primary analyses were based on the in‐study observation period. Results: In total, 182 participants initiated oral semaglutide (mean age, 58.6 years; HbA1c, 8.0%; BW, 93.7 kg). The estimated changes (95% confidence interval) from baseline to EoS in HbA1c and BW were −1.09% points (−1.24, −0.94; p <.0001) and −7.17% (−8.24, −6.11; p <.0001), respectively. At EoS, 53.7% of participants had HbA1c levels <7%; 39.3% and 31.6% reached HbA1c reduction ≥1% point plus BW reduction ≥3% and ≥5%, respectively. Treatment satisfaction significantly increased (DTSQ status, +4.47 points; DTSQ change, 11.83 points; both p <.0001). At EoS, 75.3% of participants remained on oral semaglutide (55.5% received oral semaglutide 14 mg). No new safety signals were identified for oral semaglutide. Conclusions: In PIONEER REAL Canada, participants treated with oral semaglutide in routine clinical practice experienced clinically relevant reductions in HbA1c and BW and increased treatment satisfaction. [ABSTRACT FROM AUTHOR]

Economically developed countries continue to find that venous thromboembolism (VTE) is a major cause of morbidity and mortality. To compare baseline risk profiles and patient workflow patterns between the United States (U.S.) and Canadian management of VTE patients from 2014 to 2017. The Global Anticoagulant Registry in the FIELD (GARFIELD-VTE) is a prospective, observational study of 10,679 patients with objectively confirmed VTE, followed for 3 years. In total 1101 patients enrolled in the U.S. and Canada were included in this analysis. Median age and body mass index were comparable between the U.S. (60.5; 30.2) and Canadian (59.7; 29) patients. A higher percentage of U.S. patients were black (n = 128, 24.1 %; n = 22, 3.9 %) and had a higher VTE-associated risk profile, including immobilization, hospitalization, and recent surgery. U.S. patients had a higher combined DVT and PE primary diagnoses (20.3 %) and were more likely to be treated in hospitals (77.2 %) than Canadians (13.3 %; 48.1 %). Direct oral anticoagulant therapy (DOAC) was nearly two-fold more frequent in Canadian patients (n = 218, 39.2 %) at the end of 3 years in comparison to the U.S. (n = 118, 23.0 %). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, the risk of all-cause mortality was 51.9 % higher in patients from the U.S. compared to those in Canada after 3 years. Patients from the U.S. also had a higher likelihood of hospitalization, major bleeding, and recurrent VTE after controlling for prior history and comorbid conditions. Higher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies. Global, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD – Venous Thromboembolism (GARFIELD-VTE). 531 U.S. and 557 Canadians patients included in study. DOAC use more frequent in Canadian patients after 3 years than U.S. (39.2 % vs. 23.0 %, respectively). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, all-cause mortality risk remained higher in U.S. patients vs. Canadian patients after 3 years. U.S. patients had higher likelihood of hospitalization, major bleeding, and recurrent VTE. Higher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and composition of specialists and their subsequent treatment strategies. Global, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD – Venous Thromboembolism (GARFIELD-VTE). Higher rates of adverse VTE-associated outcomes were observed in U.S. patients vs Canadian patients, which may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies. [ABSTRACT FROM AUTHOR]

Introduction: This retrospective, observational study aimed to analyze and assess adherence, persistence, dosing, and use of concomitant medications of seven self-administered target drugs (abatacept, golimumab, secukinumab, tocilizumab, ustekinumab, apremilast, and tofacitinib) that are currently available in Canada for the treatment of inflammatory arthritis (IA). Methods: We used IQVIA's longitudinal claims databases, which include private drug plans and public plans. Patients with IA identified using a proprietary indication algorithm who initiated treatment with any of the target drugs between January 2015 and February 2019 were selected and followed for 12 months. Results: Golimumab and apremilast had the highest proportion of patients (~ 75%) who were bio-naïve and secukinumab had the fewest bio-naïve patients (~ 43%). The oral therapies, apremilast and tofacitinib, had the lowest percentage of adherent patients (73% and 71%) followed by abatacept (83%), while the remaining drugs had adherence around 90%. Secukinumab and tofacitinib had the highest 12-month persistence rate (63% and 61%), while abatacept and apremilast had the lowest persistence rate (52% and 47%). Oral corticosteroid (OCS) use was not significantly associated with adherence. Tocilizumab, secukinumab, and ustekinumab had the highest proportion of patients (> 20%) with dose escalation at 3–4 months from index. OCS and conventional disease-modifying antirheumatic drugs (cDMARD) use decreased in post-index period across all target drugs. Conclusion: This study identified substantial differences in patient baseline characteristics. Patients on injectable biologics were more likely to be adherent compared with those on oral drugs, possibly owing to longer dosing intervals. Other outcomes at 12 months appeared similar as evidenced by tapering of concomitant medications, although differences in persistence and dose escalation were noted. [ABSTRACT FROM AUTHOR]

Aim: To investigate once‐weekly (OW) semaglutide, a glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), in patients with type 2 diabetes (T2D) in routine clinical practice. Methods: The SURE Canada study was a multicenter, prospective, observational study. Adults with T2D and one or more documented HbA1c values 12 weeks or less before semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~30 weeks). Secondary endpoints included change in body weight (BW), waist circumference and patient‐reported outcomes (PROs) and the proportion of patients achieving HbA1c of less than 7.0%, weight loss (WL) of 5% or higher, and a composite of HbA1c reduction of 1% or higher and WL of 3% or higher at EOS. Data were analysed and presented for patients on semaglutide at EOS overall and for the following baseline medication subgroups: oral antihyperglycaemic drugs (OADs) only; GLP‐1RA experienced; insulin ± OADs without GLP‐1RA. Results: In total, 452 patients initiated semaglutide and 356 completed the study on treatment. For the 452 patients, mean baseline HbA1c was 8.1%; 86 (19.0%) patients had HbA1c of less than 7.0%. Mean dose of semaglutide at EOS was 0.76 ± 0.31 mg. Mean HbA1c was reduced by 0.9%‐point (95% confidence interval [CI]: 0.97; 0.78). Mean BW was reduced by 4.3 kg (95% CI: 4.79; 3.76). At EOS, 46.9% of patients achieved HbA1c of less than 7.0%, 40.9% achieved WL of 5% or higher and 24.1% achieved the composite endpoint. PROs improved from baseline to EOS. No new safety concerns were reported. Conclusions: In SURE Canada, patients treated with OW semaglutide in routine clinical practice experienced clinically significant improvements in HbA1c, BW and other outcomes, supporting semaglutide use in routine clinical practice. [ABSTRACT FROM AUTHOR]

Purpose Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. Objective The objective of this study was to examine generic drug reviews in Japan and Canada. Methods We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. Results This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. Conclusions The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada. [ABSTRACT FROM AUTHOR]

Linked Article: Alavi et al. Br J Dermatol 2022; 186:803–813. Hidradenitis suppurativa (HS) is a rare chronic skin condition with painful nodules (bumps) and abscesses (liquid‐filled lesions) that may result in tunnel formation and scarring. There are currently limited options to treat HS, and responses to medication and duration of responses varies among patients. The authors of this study are from the USA and Canada. An oral drug (INCB054707) that targets a process called 'Janus kinase‐mediated inflammation' was tested in two clinical trials of adult patients with HS. Across the two studies, 45 patients received one of four dosage strengths of INCB054707 or a placebo pill (which looked like the drug being tested but did not contain any medicine) for 8 weeks. They checked for adverse side‐effects. The number of HS lesions over time were measured to see if the treatment was working. Patients were asked to describe their worst skin pain and quality of life at various times during the study. In patients treated with INCB054707 the side‐effects were generally mild, and only one of the 36 patients treated with INCB054707 stopped taking the drug completely for safety reasons. Patients taking higher doses of the drug had improved skin condition at the end of 8 weeks compared with those who received placebo. More patients who took INCB054707 also had less skin pain and felt that their quality of life was better during treatment compared with the patients who got placebo pills only. In conclusion, this may be a possible new treatment for HS. Additional studies with larger numbers of patients are underway. Linked Article: Alavi et al. Br J Dermatol 2022; 186:803–813. [ABSTRACT FROM AUTHOR]

Linked Article: van Zuuren et al. Br J Dermatol 2021; 185:36–51. Acne is a common skin disease that causes a lot of burden and distress. Acne can be treated with medication applied to the skin (e.g. creams) and with oral medication (e.g. tablets). It is important to know how satisfied people with acne actually are with their treatment. So this should be measured in studies that evaluate acne treatments. Ideally, all researchers should measure patient satisfaction with acne treatment in exactly the same way. Only then those studies and treatments can be compared. Our aim was to find out how researchers measured treatment satisfaction in acne, and if there were any methods that could be recommended. We, a team from the Netherlands and Canada, found 255 studies that mentioned satisfaction with acne treatment. Of these, there was only one study that described a method of how patients' treatment satisfaction with acne medication could be measured. However, we judged that method not scientifically good enough to recommend. Sixty‐six studies appeared, after thorough examination, not to report treatment satisfaction or were published more than once. The remaining 188 studies did measure patient satisfaction: 91 studies on treatment of acne with medication and 97 on treating acne scars. Some used one question, some a questionnaire. There were many differences in how the questions could be answered and scored. This makes comparing studies on patient satisfaction with acne treatment very difficult. The conclusion of our study is that there is not yet a method that measures patients' satisfaction with treatments in acne that is good enough to be used by all researchers. We recommend that such a method is developed and then used in all studies so that in the future the results of those studies on treatment satisfaction can be compared. Linked Article: van Zuuren et al. Br J Dermatol 2021; 185:36–51. [ABSTRACT FROM AUTHOR]