Prevalence and burden of vitiligo in Africa, the Middle East and Latin America.

Vitiligo is a common chronic autoimmune disorder characterized by skin and hair depigmentation that affects 0.5%-2.0% of the global population. Vitiligo is associated with diminished quality of life (QoL) and psychosocial burden. The burden of vitiligo may vary based on skin tone and cultural differences as well as geographical variations in disease awareness, societal stigma, healthcare systems and treatment options. Data on the burden and management of vitiligo in Africa, the Middle East and Latin America are scarce. Literature searches using terms covering vitiligo in Africa, the Middle East and Latin America were conducted using PubMed to identify relevant publications that focused on disease prevalence and burden, QoL and psychosocial impact and disease management between 2011 and 2021. Most of the reviewed studies were conducted in the Middle East, and most Latin American studies were from Brazil. Most studies involved small patient numbers and may not be generalizable. Reported prevalence of vitiligo ranged from 0.18% to 5.3% in Africa and the Middle East, and from 0.04% to 0.57% in Latin America. In several studies, prevalence was higher among female participants. Generally, non-segmental vitiligo was the dominant clinical variant identified and the age at onset varied widely across studies. Common comorbidities include autoimmune diseases such as Hashimoto's thyroiditis, alopecia areata and diabetes. Few treatment guidelines exist in these regions, with the exceptions of guidelines published by the Brazilian and Argentinian Societies of Dermatology. There is a clear unmet need for large epidemiological studies with uniform methodology to accurately ascertain the true prevalence of vitiligo in Africa, the Middle East and Latin America. Additional data on vitiligo burden and management in Africa and Latin America are also needed, along with local disease management guidelines that consider genetic variation, psychosocial burden and socioeconomic diversity in all 3 regions.

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.

Long-Term Adherence to Etanercept in Treatment Effectiveness of Patients with Spondyloarthritis: 7-Year Data from the Iraq National Registry.

INTRODUCTION: The diagnosis and treatment of spondyloarthritis (SpA) is a global challenge, with no cure available. Adherence to treatment with biologic disease-modifying antirheumatic drugs, such as the tumor necrosis factor-α inhibitor etanercept, varies among patients with SpA. Inadequate or poor adherence to treatment may have a negative effect on clinical outcome and quality of life and may lead to greater health-related expense. METHODS: This observational, retrospective study used real-world patient data from the Iraq National Center of Rheumatology database to retrospectively assess long-term adherence to etanercept, specifically evaluating 1- and 7-year adherence to etanercept among Iraqi patients with SpA. RESULTS: In total, data from 763 patients were included in the analysis. The majority of patients were men (82.2%). Mean disease duration at baseline was 5.85 years; 84.0% of patients received concomitant steroids, and 14.2% were treated with concomitant methotrexate. Measures of disease activity and functional status (mean ± SD) at baseline based on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) were 8.06 ± 0.83 (range 6.0-9.5) and 7.75 ± 1.12 (range 4.1-9.7), respectively. Around 30% of patients initiated etanercept treatment within 1 year of diagnosis. After 1 and 7 years, 91.7% (700/763) and 60.6% (80/132) of patients were adherent to etanercept treatment. Mean (± SD) changes from baseline in BASDAI and BASFI scores for adherent versus non-adherent patients at 1 year were 6.73 (± 1.90) versus 4.20 (± 1.85) (p = 0.0001) and 6.43 (± 2.04) versus 4.18 (± 1.88) (p = 0.0001), respectively. CONCLUSIONS: These results suggest that Iraqi patients with SpA benefit from long-term adherence to etanercept treatment; however, additional analyses are needed to further assess the reasons for treatment discontinuation, which may include disease remission. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04507776.

Epidemiology, burden of disease, and unmet needs in the treatment of ulcerative colitis in Asia.

INTRODUCTION: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the colon, characterized by relapsing and remitting symptoms. Although traditionally viewed as a Western disease, the incidence and prevalence of UC is increasing in developing regions, including Asian countries. AREAS COVERED: A PubMed search identified articles describing epidemiology, disease burden, patient demographics, clinical characteristics, risk factors, and treatment of UC across Asia. We review the epidemiology and disease course of UC across Asia, including region-specific factors that may aid development of more cost-effective treatment approaches tailored to the needs of Asian populations. EXPERT OPINION: The opinion of non-Pfizer-affiliated practicing gastroenterologists is that epidemiological data from the last four decades have shown 1.5-fold to almost 20-fold increases in the incidence and prevalence of UC in some Asian countries, although prevalence remains generally lower than in the West. As the prevalence of UC rises, so will overall healthcare costs. Disparities in healthcare systems and funding mean that different Asian countries face unique challenges in how best to use available resources, including selection from a growing number of emerging treatment options. More clinical trial and real-world data are required to help define treatment approaches that will most benefit Asian populations.

The Economic and Psychosocial Comorbidity Burden Among Adults with Moderate-to-Severe Atopic Dermatitis in Europe: Analysis of a Cross-Sectional Survey.

INTRODUCTION: Atopic dermatitis (AD) is a common inflammatory disease of the skin, which may have a substantial impact on patients' health-related quality of life (HRQoL). The aim of this study was to quantify the economic burden (direct and indirect costs) of moderate-to-severe AD and evaluate the prevalence and impact of psychosocial comorbidities among patients in the European Union-5 (France, Germany, Italy, Spain, and the UK). METHODS: Data were analyzed from the 2017 EU5 National Health and Wellness Survey. Respondents with a physician diagnosis of AD/eczema who were considered to have moderate-to-severe AD based on a Dermatology Life Quality Index (DLQI) score ≥ 6 were included. Direct costs, indirect costs, and psychosocial comorbidities (sleep difficulties and anxiety based on self-report, depression based on the Patient Health Questionnaire-9) were reported descriptively. Generalized linear models were used to examine the relationship between psychosocial comorbidities and health outcomes (the Short Form-36 version 2 [SF-36v2], EuroQoL 5-dimension 5-level, Work Productivity and Activity Impairment questionnaire, and healthcare resource utilization). RESULTS: Overall, 1014 patients were included in the analysis. Total annual direct costs ranged from €2242 to €6924 and total annual indirect costs ranged from €7277 to €14,236, depending on the level of disease severity. Sleep difficulties, anxiety, and depression were reported by 61.6%, 52.7%, and 75.8% of patients, respectively. These comorbidities were significantly associated with reduced physical and mental component summary scores from SF-36v2 and increased overall work impairment (p < 0.05 for all). CONCLUSIONS: A significant economic burden was observed for patients with moderate-to-severe AD. Sleep difficulties, depression, and anxiety were observed in more than half of moderate-to-severe AD patients and were significantly associated with decrements in HRQoL and with work-related impairment. Reducing the burden of these psychosocial comorbidities in AD could have significant benefit to patients and society.

Epidemiology, Diagnosis, and Treatment of Atopic Dermatitis in the Developing Countries of Asia, Africa, Latin America, and the Middle East: A Review.

Atopic dermatitis (AD), the leading cause of skin-related burden of disease worldwide, is increasing in prevalence in developing countries of Asia, Africa, Latin America, and the Middle East. Although AD presents similarly across racial and ethnic groups as chronic and relapsing pruritic eczematous lesions, some features of the disease may be more or less prominent in patients with darker skin. Despite a similar presentation, consistent diagnostic criteria and consistent treatment guidelines are lacking. Because of these and other challenges, adherence to treatment guidelines is difficult or impossible. Previous studies have stated that many patients with AD receive ineffective or inappropriate care, such as oral antihistamines, oral corticosteroids, or traditional medicines, if they are treated at all; one study showed that approximately one-third of patients received medical care for their dermatologic condition; of those, almost three-quarters received inappropriate or ineffective treatment. In addition, other challenges endemic to developing countries include cost, access to care, and lack of specialists in AD. Furthermore, most of the available diagnostic criteria and treatment guidelines are based on European and North American populations and few clinical trials report the racial or ethnic makeup of the study population. Drug pharmacokinetics in varying ethnicities and adverse effects in different skin physiologies are areas yet to be explored. The objective of this review is to describe the diagnosis, treatment, and management of AD in developing countries in Asia, Africa, Latin America, and the Middle East; to discuss the differences among the countries; and to establish the unmet needs of patients with AD in them. The unmet medical need for treatment of AD in developing countries can be addressed by continuing to train medical specialists, improve access to and affordability of care, and develop new and effective treatments.Funding Pfizer Inc.

Burden of atopic dermatitis in Asia.

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense pruritus and eczematous lesions. It is considered one of the most common chronic conditions, with an estimated global prevalence of nearly 230 million. As in the rest of the world, prevalence of atopic dermatitis has been increasing in Asian countries over the last few decades. This increased prevalence in Asian countries has been attributed to factors such as rapid urbanization, increasingly Westernized lifestyles, and improved standards of living and education. As a result, it is important to understand the increasing burden of disease in Asian countries and the differences between the countries in terms of epidemiology, diagnostic criteria, management, quality of life and economic burden.

Efficacy and safety of tofacitinib for the treatment of rheumatoid arthritis in patients from the Asia-Pacific region: Post-hoc analyses of pooled clinical study data.

AIM: We report tofacitinib efficacy and safety in Asia-Pacific patients who participated in the rheumatoid arthritis (RA) clinical development program. METHOD: This post-hoc analysis included pooled data from patients with RA in the Asia-Pacific region treated with tofacitinib with/without conventional synthetic disease-modifying antirheumatic drugs in Phase (P)1, 2, 3, and long-term extension (LTE) studies (one LTE ongoing; January 2016 data-cut). Efficacy was assessed over 24 months in patients who received tofacitinib 5 (N = 397) or 10 (N = 382) mg twice daily or placebo (N = 243) in three P2 and five P3 studies. Endpoints included American College of Rheumatology (ACR)20/50/70 responses, Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]) and Clinical Disease Activity Index (CDAI) remission rates, and change from baseline in Health Assessment Questionnaire-Disability Index (∆HAQ-DI). Safety data pooled over 92 months from one P1, four P2, six P3, and two LTE studies for all tofacitinib doses (N = 1464) included incidence rates (IRs) (patients with events/100 patient-years) for adverse events (AEs) of special interest. RESULTS: At month 3, patients receiving tofacitinib 5/10 mg twice daily improved vs placebo in ACR20 (69.2%/77.9% vs 27.5%), ACR50 (36.9%/44.4% vs 9.5%), and ACR70 (15.1%/22.4% vs 2.7%) responses, remission rates for DAS28-4(ESR) (8.5%/18.5% vs 2.6%) and CDAI (6.1%/12.3% vs 0.5%), and ∆HAQ-DI (-0.5/-0.6 vs -0.1); improvements were sustained through 24 months. IRs (95% CI) were 9.4 (8.5, 10.3) for serious AEs, 9.1 (8.3, 10.1) for discontinuations due to AEs, 3.7 (3.2, 4.3) for serious infections, 5.9 (5.2, 6.7) for herpes zoster, and 0.8 (0.6, 1.1) for malignancies (excluding non-melanoma skin cancer). CONCLUSION: In Asia-Pacific patients, tofacitinib improved signs/symptoms over 24 months. Safety over 92 months was generally consistent with global tofacitinib studies; however, infection IRs were higher in Asia-Pacific patients.

A Review on the Effect of Tumor Necrosis Factor Inhibitors on Structural Progression in Early Axial Spondyloarthritis Using Magnetic Resonance Imaging.

INTRODUCTION: Considering the progressive nature of axial spondyloarthritis (axSpA), it is important to determine whether tumor necrosis factor alpha (TNFα) inhibitors have an effect on early inflammatory and structural lesions detected using magnetic resonance imaging (MRI). METHODS: A search of MEDLINE/PubMed for full-text, English-language articles on randomized controlled trials (RCTs) of adalimumab, certolizumab, etanercept, golimumab, or infliximab published since January 2007 was conducted in February 2018 and again in December 2018. The collected articles reported on inflammatory or fatty lesion progression in the spine or sacroiliac joint (SIJ), determined using MRI, in a population that included at least 40% of patients with early axSpA, defined as non-radiographic axSpA. RESULTS: Of the 105 articles retrieved, 19 were included in this review, of which the majority were on etanercept (n = 11). A majority of selected articles included information on inflammatory lesions (SIJ 15/19; spine 12/19). All five TNFα inhibitors showed benefits on inflammation, assessed by MRI, in patients with early axSpA for up to 204 weeks of treatment. Structural progression in SIJ and the spine was assessed in 6/19 and 3/19 articles, respectively, with mixed evidence on benefits of TNF-inhibitor treatment. CONCLUSIONS: In conclusion, treatment with TNFα inhibitors reduces MRI-evident inflammatory lesions in the SIJ and spine of patients with early axSpA for up to 4 years. There is less evidence of benefits on structural lesions. Additional studies are required to determine whether TNFα-inhibitor therapy can limit or delay radiological progression in patients with early axSpA. FUNDING: Pfizer.

Anti-tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region.

Although anti-tumor necrosis factor (TNF) agents have greatly improved the management of rheumatic diseases, their cost limits access to many patients throughout the world. As a result, patients and clinicians have turned to biosimilars to provide similar efficacy at a lower cost. Many of the regulatory guidelines in the Asia Pacific region are largely based on those of the European Medicines Agency and the World Health Organization; however, there are variations between countries. Additionally, in some countries, intended copies are available that were approved prior to the development of guidelines and have not fulfilled the requirements of a biosimilar. We review the various regulatory requirements for biosimilars in the Asia Pacific region, the anti-TNF biosimilars and intended copies approved in the region, and whether clinical data are available for these agents. We discuss concerns about the need for additional regulations and education, and we provide recommendations for a multidisciplinary pharmacovigilance approach that closely monitors the safety of biosimilar use.

Tuberculosis and viral hepatitis infection in Eastern Europe, Asia, and Latin America: impact of tumor necrosis factor-α inhibitors in clinical practice.

Tumor necrosis factor-α (TNF-α) inhibitors are increasingly becoming the standard of care for treating a number of inflammatory diseases. However, treatment with TNF-α inhibitors carries an inherent risk of compromising the immune system, resulting in an increased susceptibility to infections and malignancies. This increased risk of infection is of particular concern in Asia, Eastern Europe, and Latin America where tuberculosis (TB) and viral hepatitis are endemic. In this brief review, we examine the literature and review the impact of TNF-α inhibitors on the incidence and the reactivation of latent disease with respect to TB, hepatitis C infection, and hepatitis B infection. Our findings show that TNF-α inhibitors are generally safe, if used with caution. Patients should be screened prior to the initiation of TNF-α inhibitor treatment and given prophylactic treatment if needed. In addition, patients should be monitored during treatment with TNF-α inhibitors and after treatment has stopped to ensure that infections, if detected, are treated promptly and effectively. Our analysis is consistent with other reports and guidelines.

Efficacy and safety of etanercept in patients from Latin America, Central Europe and Asia with early non-radiographic axial spondyloarthritis.

AIM: To evaluate etanercept in patients from Latin America, Central/Eastern Europe, and Asia with non-radiographic axial spondyloarthritis (nr-axSpA). METHODS: A subset analysis was performed on nr-axSpA patients from Argentina, Colombia, the Czech Republic, Hungary, Russia and Taiwan who were enrolled in EMBARK (NCT01258738). Patients received either etanercept 50 mg or placebo once weekly. The primary endpoint was proportion of patients achieving 40% improvement from baseline based on Assessment of SpondyloArthritis International Society (ASAS) criteria. Secondary endpoints included other efficacy assessments, health-related quality of life (HRQoL) and safety. RESULTS: Of the 117 patients in this subset, 59 were treated with etanercept and 58 received placebo. At week 12, numerically greater improvements from baseline were observed for all efficacy endpoints in etanercept-treated patients compared with those receiving placebo. Statistically significant differences between the two treatment groups were observed for proportion of patients achieving ASAS40 (P = 0.0413, at week 8), ASAS5/6 (P = 0.0126), Ankylosing Spondylitis Disease Activity Score - C-reactive protein (CRP) inactive disease (P = 0.0093), Spondyloarthritis Research Consortium of Canada magnetic resonance imaging of sacroiliac joint scores (P = 0.0014), high-sensitivity CRP (P=0.032), and erythrocyte sedimentation rate (P = 0.0082). Statistically significant improvements in the etanercept-treated group compared with placebo group were observed for nocturnal back pain (P = 0.040), total back pain (P = 0.025), physician global assessment of disease (P = 0.023), and Work Productivity and Activity Impairment Questionnaire percent impairment while working (P = 0.047). Adverse events were similar between the two treatment groups. CONCLUSIONS: In this subset of patients with nr-axSpA from Latin America, Central/Eastern Europe, and Asia, treatment with etanercept, compared with placebo, resulted in improved disease symptoms and patient HRQoL. Etanercept was well tolerated.

Dosing down and then discontinuing biologic therapy in rheumatoid arthritis: a review of the literature.

AIM: To review the published studies that dose down and then discontinue biologic therapy in patients with rheumatoid arthritis (RA), particularly concerning the criteria for such dosing and the impact on clinical outcomes. METHODS: Published studies conducted in patients with RA that sequentially decreased the dose and then discontinued therapy were included if one or more of the following biologic disease modifying antirheumatic drugs (bDMARDs) was evaluated: abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab. RESULTS: Five studies qualified for inclusion. The populations of patients with RA were heterogeneous among the studies; patients were required to have low disease activity (LDA) or to be in remission prior to dose titration. Approximately 25-65% of patients successfully decreased and in some cases, discontinued the bDMARD. However, the flare rate was higher than for the patients who remained on a standard dose. The only variable that predicted relapse in more than one study was down-titration of the bDMARD dose. CONCLUSION: In patients who have achieved LDA or remission, down-titration and discontinuation of bDMARD therapy may be attempted, with careful monitoring. However, it is likely that some patients will flare, and it is not known how to predict these patients.

The prevalence and clinical characteristics of nonradiographic axial spondyloarthritis among patients with inflammatory back pain in rheumatology practices: a multinational, multicenter study.

BACKGROUND: Patients with ankylosing spondylitis (AS), who by definition have radiographic sacroiliitis, typically experience symptoms for a decade or more before being diagnosed. Yet, even patients without radiographic sacroiliitis (i.e., nonradiographic axial spondyloarthritis [nr-axSpA]) report a significant disease burden. The primary objective of this study was to estimate the prevalence and clinical characteristics of nr-axSpA among patients with inflammatory back pain (IBP) in rheumatology clinics in a number of countries across the world. A secondary objective was to estimate the prevalence of IBP among patients with chronic low back pain (CLBP). METHODS: Data were collected from 51 rheumatology outpatient clinics in 19 countries in Latin America, Africa, Europe, and Asia. As consecutive patients with CLBP (N = 2517) were seen by physicians at the sites, their clinical histories were evaluated to determine whether they met the new Assessment of SpondyloArthritis international Society criteria for IBP. For those who did, their available clinical history (e.g., family history, C-reactive protein [CRP] levels) was documented in a case report form to establish whether they met criteria for nr-axSpA, AS, or other IBP. Patients diagnosed with nr-axSpA or AS completed patient-reported outcome measures to assess disease activity and functional limitations. RESULTS: A total of 2517 patients with CLBP were identified across all sites. Of these, 974 (38.70 %) fulfilled the criteria for IBP. Among IBP patients, 29.10 % met criteria for nr-axSpA, and 53.72 % met criteria for AS. The prevalence of nr-axSpA varied significantly by region (p < 0.05), with the highest prevalence reported in Asia (36.46 %) and the lowest reported in Africa (16.02 %). Patients with nr-axSpA reported mean ± SD Ankylosing Spondylitis Disease Activity Scores based on erythrocyte sedimentation rate and CRP of 2.62 ± 1.17 and 2.52 ± 1.21, respectively, indicating high levels of disease activity (patients with AS reported corresponding scores of 2.97 ± 1.13 and 2.93 ± 1.18). Similarly, the overall Bath Ankylosing Spondylitis Disease Activity Index score of 4.03 ± 2.23 for patients with nr-axSpA (4.56 ± 2.17 for patients with AS) suggested suboptimal disease control. CONCLUSIONS: These results suggest that, in the centers that participated in the study, 29 % of patients with IBP met the criteria for nr-axSpA and 39 % of patients with CLBP had IBP. The disease burden in nr-axSpA is substantial and similar to that of AS, with both groups of patients experiencing inadequate disease control. These findings suggest the need for early detection of nr-axSpA and initiation of available treatment options to slow disease progression and improve patient well-being.

Assessment of clinical efficacy and safety in a randomized double-blind study of etanercept and sulfasalazine in patients with ankylosing spondylitis from Eastern/Central Europe, Latin America, and Asia.

Despite the demonstrated efficacy of etanercept for the treatment of ankylosing spondylitis (AS), sulfasalazine is often prescribed, especially in countries with limited access to biologic agents. The objective of this subset analysis of the ASCEND trial was to compare the efficacy of etanercept and sulfasalazine in treating patients with AS from Asia, Eastern/Central Europe, and Latin America. A total of 287 patients, 190 receiving etanercept 50 mg once weekly and 97 receiving sulfasalazine 3 g daily, from eight countries were included in this subset analysis. Differences in disease activity and patient-reported outcomes assessing health-related quality-of-life (HRQoL) parameters in response to treatment were analyzed using the Cochran-Mantel-Haenszel test for categorical efficacy endpoints and analysis of covariance model for continuous variables. At week 16, a significantly greater proportion of patients receiving etanercept achieved ASAS20 (79.0 %) compared with patients receiving sulfasalazine (61.9 %; p = 0.002). At week 16, treatment with etanercept also resulted in significantly better responses than sulfasalazine for ASAS40 (64.7 vs. 35.1 %; p < 0.001), ASAS5/6 (48.1 vs. 26.3 %; p < 0.001), proportion of patients achieving 50 % response in Bath AS Disease Activity Index (65.8 vs. 42.3 %; p < 0.001), partial remission (35.3 vs. 17.5 %; p = 0.002), and all HRQoL parameters. Both treatments were well tolerated. Etanercept was significantly more effective than sulfasalazine in the treatment of patients with AS from Asia, Central/Eastern Europe, and Latin America.

Determination of normative bone mineral density values in Filipino women

OBJECTIVE: To obtain reference values of bone mineral density (BMD) for Filipino women in order to make a population-specific diagnosis of osteoporosis.SETTING: Osteoporosis Unit, Joint and Bone Center, Section of Rheumatology and Clinical Immunology, Department of Medicine, University of Santo Tomas Hospital, Manila, Philippines. PARTICIPANTS: 442 healthy Filipino women volunteers recruited from the outpatient department, Rheumatology and Clinical Immunology Clinic of the University of Santo Tomas Hospital and from within the University of Santo Tomas campus. Subjects with known underlying illness or conditions or intake of drugs that predispose to osteoporosis were excluded from the study. INTERVENTION: Bone mineral density (BMD) measurements, expressed in grams per square centimenter of the lumbar spine, non-dominant femur and non-dominant forearm were done in 442 consecutive healthy Filipino women using the LUNAR DPX-IQ machine. RESULTS: Means and standard deviations of BMD measurements at each site were calculated using Kwikstat software Version 3.6, Release 7. Results were grouped in decades to serve as reference per decade. CONCLUSION: BMD of these 442 healthy Filipino women may serve as an initial reference guide for the diagnosis of osteoporosis in Filipino women.

Consensus statements on osteoporosis diagnosis, prevention, and management in the Philippines.

OBJECTIVE: The consensus statements were developed to assist healthcare practitioners in providing optimal care to postmenopausal individuals at risk for osteoporosis and fragility fractures in the local setting. METHODOLOGY: The Technical Review Committee formed by the Osteoporosis Society of the Philippines Foundation Inc. in cooperation with the Philippine Orthopedic Association drafted, retrieved available published evidence, and appraised important issues on osteoporosis and fragility fractures. The Appraisal of Guidelines Research and Evaluation instrument was used to appraise published guidelines while a systematic way of validating the quality of evidence and the level of recommendation was done using the GRADE system. A multidisciplinary panel of experts and stakeholders in an en banc meeting conferred and approved the recommendations. RESULTS AND CONCLUSION: There were five key issues on preventive, seven on diagnostic, nine on therapeutic aspects of osteoporosis with four other surgical concerns on fragility fractures. All were approved by a panel of stakeholders through a majority vote. These statements will best inform the clinicians and the specialists including orthopedic surgeons and general care practitioners on issues of postmenopausal Filipino women at risk for osteoporosis and fragility fractures.

Pregabalin in neuropathic pain syndromes: A post-marketing surveillance study on efficacy,safety and tolerability

CONTEXT: Pregabalin has shown efficacy in the treatment of multiple chronic pain syndromes. OBJECTIVES: The objective was to evaluate the overall safety and tolerability of pregabalin in the treatment of a several neuropathic pain syndromes in a naturalistic setting using a flexible dosage regimen.METHODS: Patients aged >- 18 years with neuropathic pain of various etiologies participated in an open-label, non-comparative study at 95 sites in the Philippines. Treatment included pregabalin for 4 weeks, with upward dosage titration to 600 mg/day at investigator discretion. Efficacy was rated with an 11-point pain visual analog scale (VAS). Physicians and patients rated pregabalin on treatment satisfaction, efficacy and safety using a Clinical Global Impression (CGI) rating scale. Descriptive statistics were used for quantitative variables and categorical frequency counts for qualitative variables. RESULTS: The efficacy analysis (intent-to-treat) included 1603 patients. Mean VAS pain score improved from baseline (7.2 +- 1.6) to 3.8 +- 1.8 at second visit and 2.3 +- 1.4 at last visit. Physicians' and patients' impression of pregabalin regarding treatment satisfaction, efficacy and safety using a CGI rating scale showed> 75% who gave a rating of excellent at second visit gave the same rating at final visit. Adverse events (AEs) were generally mild to moderate, with dizziness and somnolence most frequently reported. DISCUSSION: Improvement in mean VAS pain scores as well as physicians' and patients' overall satisfaction with tolerability and efficacy support the usefulness of pregabalin in the treatment of various neuropathic pain syndromes in Asian patients. WHAT'S KNOWN? Pregabalin is effective for the treatment of chronic pain syndromes, including painful diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. WHAT'S NEW? This open-label, non-comparative study demonstrates safety, tolerability and efficacy for neuropathic pain syndromes in Asian patients.

Validation of OSTA among Filipinos.

Osteoporosis is the most common metabolic bone disease in humans. It is a special concern not only among postmenopausal women, but men as well. In developing countries where there are meager resources, it will definitely be helpful to search for ways to identify patients with low bone mineral density who have a high risk of future fractures. These people need to be identified for treatment consideration in order to reduce the incidence of the disease and its complications. A simple risk index called the Osteoporosis Screening Tool for Asians (OSTA), based only on two variables, age and body weight, performed well in identifying the risk of osteoporosis among postmenopausal women. This index has been validated in Japan, Korea and other Caucasian populations as a useful tool in identifying individuals who will require BMD measurement. This is the first study that validated the said index in 1,597 Filipino women and men referred to a tertiary center for BMD measurement. It had sensitivity of 97 and 90% and specificity of 59 and 66% with areas under the curve of 0.8506 and 0.8475, respectively, for women and men. We conclude that OSTA performed just as well or even better than other indices used in other populations to identify individuals who are at varying degrees of risk for osteoporosis. The tool also proves to be a useful and practical guide to help clinicians to be more prudent and judicious in employing bone mineral density measurement.