Physicians' and patients' perception of biosimilars and factors affecting biosimilar prescribing in selected Asian Countries: a survey study.

BACKGROUND: This study evaluated physicians' and patients' beliefs about biosimilars in Hong Kong, India, Pakistan, Singapore, Taiwan, and Thailand. RESEARCH DESIGN AND METHODS: An onlne survey administered to physicians (dermatologists, n = 119; gastroenterologists, n = 148; rheumatologists, n = 161) between 22 October 2021 and 7 January 2022, and patients (n = 90) with rheumatic or inflammatory bowel disease between 25 October 2021 and 12 April 2022. RESULTS: Most (68%) physicians reported having a strong knowledge about biosimilars, yet 49% indicated that biosimilars are readily available to them. Physicians cited potential cost savings (81%) as the main benefit of biosimilars, and cost/coverage support (36%), patient support (25%), and increasing biosimilar awareness/education (24%) as main strategies for improving usage. Few (21%) patients reported having a strong knowledge about biosimilars. Patients cited offering alternatives in case of drug shortages (77%) as the main benefit of biosimilars, and cost/coverage support (53%), increasing awareness of product profile (22%), and providing biosimilars with a good efficacy profile/effective product (19%) as main strategies for improving usage. CONCLUSION: Programs focused on cost/coverage support, patient support, and biosimilar awareness could improve acceptance of biosimilars for chronic immune-mediated inflammatory diseases in Asian countries, thereby increasing patient access to essential biologic therapies.

Biologic medicines come from living organisms such as viruses, bacteria, and animal or plant cells. Biosimilars are approved biologic medicines that are highly similar in structure to original biologic medicines. This study was done to understand what people with diseases that cause long-lasting inflammation of the joints, intestines, or skin (inflammatory diseases for short) and their doctors think about biosimilars. Researchers focused on people and doctors living in six Asian countries (Hong Kong, India, Pakistan, Singapore, Taiwan, and Thailand) with economies and health systems that are advanced or becoming more advanced. Researchers used an online survey to ask people with inflammatory diseases (or people responders) (90 in total) and their doctors (428 in total) what they think about biosimilars. Most doctors (68%) and some people responders (21%) said they had a good understanding of biosimilars. Doctors thought the main benefit of using biosimilars was the possibility of achieving cost savings. People responders thought the main benefit was the possibility of having additional treatment options in case of shortages of the original biologic medicine. Doctors said they sometimes cannot prescribe biosimilars because the cost may still be too high for some patients or because they worry about the quality of biosimilars and how well they work. Programs that increase awareness of biosimilars and that provide financial and other support for biosimilars could improve biosimilar use as treatment for inflammatory diseases in Asian countries, giving more patients access to important biologic medicines in this region.

Psychosocial Burden of Psoriasis: A Systematic Literature Review of Depression Among Patients with Psoriasis.

Psoriasis is associated with various comorbidities with a notable psychosocial burden. This systematic literature review explores the burden of depression in patients with psoriasis, comparing it with that experienced by patients with other chronic medical conditions. Embase via Ovid, PubMed, and Cochrane Database of Systematic Reviews via Ovid were searched for peer-reviewed studies published in English between January 1, 2016 and December 6, 2021 that reported real-world evidence or observational studies involving at least 100 adults (age ≥ 18 years) with general (unspecified) or plaque psoriasis experiencing symptoms of depression (but not restricted to patients with a clinical diagnosis). Any report of depression or suicidality was eligible for inclusion. Systematic literature reviews reporting depression/suicidality in other chronic medical conditions were also included. Statistical analysis was not performed; the study was descriptive only. A total of 1744 records were identified, and after several defined screenings by two independent reviewers for publication year, relevance, and sample size, 82 publications were included. Psoriasis was significantly associated with depression. The prevalence of depression in patients with psoriasis ranged from 0.2% to 74.6%, with incidence from 4.83 to 91.9 per 1000 person-years. The prevalence of depression was generally higher among patients with more severe psoriasis than those with less severe disease (as determined by Psoriasis Area Severity Index [PASI] scoring system) and was more prevalent among women than men with psoriasis. Depression in psoriasis significantly reduced quality of life, including factors such as sexual dysfunction, sleep difficulties, subjective well-being, and addictions. Comorbid hypertension, hyperlipidemia, psoriatic arthritis, obesity, inflammatory bowel disease, diabetes, and statin use were all associated with increased depression risk in patients with psoriasis. This systematic literature review found that the burden of depression in psoriasis is no lower than in other chronic medical conditions. Greater awareness of the psychological impact of psoriasis would improve care and management, which should incorporate psychological interventions.

Rheumatoid arthritis management in the APLAR region: Perspectives from an expert panel of rheumatologists, patients and community oriented program for control of rheumatic diseases.

Rheumatoid arthritis (RA) is a major health burden in Asia Pacific affecting the quality of life of patients and consuming healthcare resources. According to recent estimates from the World Health Organization-International League Against Rheumatism-Community Oriented Program for Control of Rheumatic Diseases, prevalence is around 0.3%-0.5%. Management guidelines have helped to improve treatment across this diverse region. To gain better insight into current real-world management applications in view of these guidelines, virtual meetings were conducted in mid-2020 to explore perspectives of rheumatologists and patients, as well as discuss the impact of coronavirus disease 2019 on RA management. Patients and rheumatologists from Hong Kong, Malaysia, Singapore, the Philippines, Thailand, India, Pakistan, and Taiwan were included, representing a diverse mix of healthcare systems, wealth, ethnicity and culture. Despite many countries having prospered in recent years, similar challenges in RA diagnosis and treatment were identified. The daily impact and patient experience of RA were also similar across countries, marked by "silent" pain and disability, and universal misunderstanding of the disease. Late diagnosis and treatment, and barriers to access to appropriate treatment, remain problematic. The experience shared by Taiwan offers a glimmer of hope, however, wherein patient advocacy groups have succeeded in being included in policy-making decisions and securing access to advanced treatment. Real-world solutions that pay heed to the unique local needs and diversity of Asia Pacific are required to improve RA management, which will take time. In the interim, help can be sought from the trained, non-rheumatologist community to reduce some of the disease burden.

The role of orthobiologics in foot and ankle surgery: Allogenic bone grafts and bone graft substitutes.

Orthobiologics are biological substances that are used therapeutically for their positive effects on healing skeletal and soft-tissue injuries. The array of orthobiological products currently available to the foot and ankle surgeon is wide, and includes bone allografts, bone substitutes, growth factors, and chondral scaffolds. Nonetheless, despite the surge in interest and usage of orthobiologics, there remains a relative paucity of research addressing their specific applications in foot and ankle surgery. In this review, we attempt to provide an overview of the literature on commonly available allogenic bone grafts and bone substitutes.There is Level II, III and IV evidence addressing allogenic bone grafts in primary arthrodesis and osteotomy procedures in foot and ankle surgery, which compares favourably with autogenic bone grafts in terms of fusion rates and clinical outcomes (often with fewer complications), and supports a Grade B recommendation for its use.Pertaining to bone substitutes, the multiplicity of products, coupled with a lack of large prospective clinical trials, makes firm recommendations difficult. Level II and IV studies of calcium phosphate and calcium sulphate products in displaced intra-articular calcaneal fractures have found favourable results in addressing bone voids, maintaining reduction and promoting union, meriting a Grade B recommendation. Evidence for TCP is limited to level IV studies reporting similarly good outcomes in intra-articular calcaneal fractures, warranting a Grade C recommendation. The use of demineralised bone matrix products in hindfoot and ankle fusions has been described in Level II and III studies, with favourable results in achieving fusion and good clinical outcomes, supporting a Grade B recommendation for these indications.Overall, despite the general lack of high-level evidence in foot and ankle surgery, allogenic bone grafts and bone substitutes continue to hold front-line roles in treating the bone defects encountered in trauma, tumour, and deformity correction surgery. However, more investigation is required before firm recommendations can be made. Cite this article: EFORT Open Rev 2017;2:272-280. DOI: 10.1302/2058-5241.2.160044.

CCM8: the eighth international symposium on inorganic carbon uptake by aquatic photosynthetic organisms.

The articles in this special issue of Photosynthesis Research arose from the presentations given at the Eighth International Symposium on Inorganic Carbon Uptake by Aquatic Photosynthetic Organisms held from May 27 to June 1, 2013 in New Orleans, Louisiana USA. The meeting covered all the aspects of CO2 concentrating mechanisms (CCMs) present in photosynthetic bacteria, microalgae and macrophytes, and spanned disciplines from the molecular biology of CCMs to the importance of CCMs in aquatic ecosystems. The publications in this special issue represent our current understanding of CCMs and highlight recent advances in the field. The influences of CCMs on algal biofuel production as well as recent efforts to use the CCM to improve crop plants are also explored.

Graft infection following arthroscopic anterior cruciate ligament reconstruction: a report of four cases.

Septic arthritis following arthroscopic anterior cruciate ligament reconstruction (ACL) is a rare complication and associated with severe morbidity. Its risk factors include (1) concomitant procedures during the reconstruction, (2) previous knee surgery, (3) allograft usage, (4) peri-operative wound contamination, and (5) presence of intra-articular foreign bodies. We present a series of 3 men and one woman aged 22 to 35 years who developed septic arthritis following ACL reconstruction. The risk factors identified were local infection (n=2), previous ipsilateral knee surgery (n=2), and the use of an allograft (n=1). All patients underwent emergency knee washout and debridement with graft retention within 24 hours, together with a course of intravenous antibiotic therapy. All the patients achieved eradication of their infections (with intact ACL grafts) and satisfactory functional outcome at a mean follow-up of 32 (range, 25-45) months.

The relationship between body mass index and physical activity levels in relation to bone mineral density in premenopausal and postmenopausal women.

UNLABELLED: We prospectively analyzed 283 women to evaluate the effects of body mass index (BMI) and physical activity levels on bone mineral density (BMD) progression in pre- and postmenopausal women over 2 years. In postmenopausal women, lower BMI was linked with worsening BMD, and moderate activity levels were associated with a lower likelihood of worsening BMD at 2 years. PURPOSE: The aim of our study is to evaluate the effects of BMI and physical activity levels on BMD progression in pre- and postmenopausal Asian women over 2 years. METHODS: We prospectively analyzed 283 women from 2006 to 2009. They were divided into two groups (159 pre- and 124 postmenopausal) and analyzed separately to avoid confounding by age and menopausal hormonal status. The mean follow-up period was 771 days. Demographic data was obtained, including medical history, calcium supplementation, BMI, and physical activity levels (IPAQ scale). Bilateral femoral neck BMD was determined at the time of recruitment, 1 year, and after 2 years. Generalized linear modeling was used to evaluate the effects of BMI and physical activity levels on BMD progression over a 2-year period. RESULTS: Amongst premenopausal women, lower initial femoral neck BMD scores were linked to worsening BMD (p = 0.048). In postmenopausal women, lower BMI was linked with worsening BMD (p = 0.012). Postmenopausal patients with moderate activity levels had a lower likelihood of worsening BMD at 2 years (p = 0.038). High physical activity levels were linked to a lower risk of BMD worsening (p = 0.066). CONCLUSIONS: Higher BMI scores are protective for osteoporosis in postmenopausal women. Moderate levels of physical activity are beneficial for bone health in postmenopausal women, while low physical activity levels are not helpful. We recommend that, in the secondary prevention of osteoporosis, postmenopausal women should be encouraged to participate regularly in moderate physical activities. A practical approach would be walking 30 min a day for at least 5 days per week.

Massive haemorrhage from the internal iliac artery following a low energy superior pubic ramus fracture in a 73-year-old man.

We report a case of a 73-year-old man with a background of aspirin use who fell and sustained a minimally displaced right superior pubic ramus fracture. He subsequently developed hypotension that necessitated fluid resuscitation, associated with a significant drop in blood haemoglobin levels that required a packed red blood cell transfusion. CT scans revealed the presence of two pelvic haematomas, with ongoing bleeding. An angiogram demonstrated bleeding from the superior vesical branch of the anterior division of the right internal iliac artery, which was successfully embolised with gelfoam slurry. The patient recovered uneventfully thereafter. This is a unique case involving an unexpected injury to the superior vesical branch of the anterior division of the internal iliac artery following low energy trauma to an elderly man. We recommend that patients who develop hypotension following a seemingly-benign isolated pubic ramus fracture be evaluated for concomitant arterial injuries with the relevant CT imaging and angiography.

Total hip arthroplasty in above-knee amputees: a case report.

There are previous case reports in the literature that describe total knee and total hip arthroplasty (THA) in below-knee amputees, but we could find no case reports on above-knee amputees (AKAs) who have severe osteoarthritis of the hip. We present a case involving an AKA who developed severe osteoarthritis of the ipsilateral hip. Out patient underwent THA with a satisfactory postoperative outcome. Technical considerations for AKAs undergoing THA are also reviewed.

Improved clinical outcomes after high-flexion total knee arthroplasty: a 5-year follow-up study.

The purpose of this study was to determine if high-flexion total knee arthroplasty resulted in improved outcomes compared with conventional total knee arthroplasty. This was a prospective, double-blind, randomized controlled trial involving 76 patients over 5 years. We compared the postoperative flexion range, Knee Society scores, Oxford knee scores, and SF-36 scores between 2 groups. The high-flexion group was able to achieve a significant sustainable increase in postoperative knee flexion angle; and this correlated to a significant improvement in the General Health, Vitality, and Physical Functioning scales of SF-36 at 5 years postoperatively. Our results signify that high-flexion total knee arthroplasty has additional benefits to the quality of life in patients who require higher degrees of knee flexion in their activities of daily living.

Massive wear and metallosis of an Acetabular Cup System presenting as pseudodislocation.

In primary and revision total hip arthroplasty (THA), the acetabular component continues to pose greater challenges than the femoral component. Numerous factors lead to polyethylene wear, which subsequently affects primary THA survival. Progressive polyethylene wear is associated with the occurrence of osteolysis, especially overlying the acetabulum, which can lead to component loosening and subsequent revision. Polyethylene failure usually manifests as massive liner wear up to the metal shell, fracture of the liner, or a combination of both. There is often a small amount of metallosis associated with this pathology. To our knowledge, massive wear of the acetabular metal shell, however, has not previously been reported in the literature. This article describes a case of massive wear through a polyethylene liner and the acetabular metal shell of an Acetabular Cup System (DePuy, Leeds, United Kingdom) that presented as an apparent dislocation 13 years following the index operation. The pseudodislocation was intraoperatively found to be penetration of the femoral head through the acetabular shell. The acetabular component was consequently revised to a larger cementless cup. The femoral component was mechanically stable and required no revision. Patients with long-standing Acetabular Cup System THA may experience acetabular metal shell wear-through phenomena presenting as a pseudodislocation, and this possibility should be taken into consideration during preoperative planning.

The safety and efficacy of sildenafil citrate (Viagra TM) in the treatment of erectile dysfunction among Filipino men: A real-world study

Objective: The aim of the study was to assess the safety/tolerability and the efficacy of sildenafil citrate (Viagra TM) in Filipino patients diagnosed with erectile dysfunction (ED) of different etiologies and severityMethodology: This is an open-label, multi-center study, with the primary objective of obtaining adverse reactions that may occur with the use of sildenafil citrate (Viagra TM) 25 mg, 50 mg or 100 mg once daily on as per needed basis, in the out-patient clinic setting across the Philippines. As a secondary endpoint, the study evaluates the efficacy of sildenafil citrate (Viagra TM) in the everyday clinical practice of Filipino physicians, using the Patient Global Efficacy Assessment Questions. Safety and toleration were assessed on the follow-up visit using unsolicited and non-leading questioning. All observed and reported events were recorded regardless of a suspected causal relationship to the study drugResults: Within a three year period, a total 3,955 study participants were enrolled in the study. Majority (57.4 percent) of the patients were suffering from organic or mixed type (a combination of both psychogenic and organic) of erectile dysfunction while 39.5 percent were of psychogenic origin. Among the adverse events reported by the patients, headache (4.5 percent), vasodilatation (2.4 percent) and dizziness (1.7 percent), showed the highest proportions. Majority (75.1 percent) reported that these were mild in nature. There were no reported serious adverse events nor were there reported deaths with the use of sildenafil citrate (Viagra TM) during the study. Majority (78.9 percent) reported improvement in their erection after taking the treatment. A fifth (19.8 percent) of the respondents failed to provide information on this item. However, almost all of the patients were either satisfied or very satisfied with the treatment representing 91.6 percent of the patientsConclusion: Sildenafil citrate (Viagra TM) is a safe and effective medication for the treatment of erectile dysfunction of various etiologies in the Filipino population. Almost all of the patients taking sildenafil citrate (Viagra) were satisfied with the treatment. The results of this study reinforce the proven safety and efficacy profile of sildenafil citrate (Viagra) among Filipino patients with erectile dysfunction. (Author)