Intravenous tocilizumab versus standard of care in the treatment of severe and critical COVID-19-related pneumonia: A single center, double-blind, placebo controlled, phase 3 trial

Background@#Severe and critical COVID-19 disease is characterized by hyperinflammation involving pro-inflammatory cytokines, particularly IL-6. Tocilizumab is a monoclonal antibody that blocks IL-6 receptors. @*Objectives@#This study evaluated the efficacy of tocilizumab in Filipino patients with severe to critical COVID-19 disease. @*Methods@#This phase 3 randomized double-blind trial, included patients hospitalized for severe or critical COVID-19 in a 1:1 ratio to receive either tocilizumab plus local standard of care or placebo plus standard of care. Patients were eligible for a repeat IV infusion within 24-48 hours if they deteriorated or did not improve. Treatment success or clinical improvement was defined as at least two categories of improvement from baseline in the WHO 7-point Ordinal Scale of patient status, in an intention-to-treat manner. @*Results@#Forty-nine (49) patients were randomized in the tocilizumab arm and 49 in the placebo arm. There was no significant difference in age, comorbidities, COVID-19 severity, need for mechanical ventilation, presence of acute respiratory distress syndrome, or biomarker levels between groups. Use of adjunctive therapy was similar between groups, with corticosteroid used in 91.8% in tocilizumab group and 81.6% in the placebo group, while remdesivir was used in 98% of participants in both groups. There was no significant difference between groups in terms of treatment success in both the intention-to-treat analysis (relative risk=1.05, 95% CI: 0.85-1.30) and per-protocol analysis (relative risk=0.98, 95% CI: 0.80 to 1.21). There was no significant difference in time to improvement of at least two categories relative to baseline on the 7-point Ordinal Scale of clinical status. @*Conclusion@#The use of tocilizumab on top of standard of care in the management of patients with severe to critical COVID-19 did not result in significant improvement as defined by the WHO 7-point Ordinal Scale of patient status, nor in significant improvement in incidence of mechanical ventilation, incidence of ICU admission, length of ICU stay, and mortality rate.

Clinical profile of Filipino patients with young-onset gout

Objectives@#Recent studies show that patients with young-onset gout present with visible tophi or nephrolithiasis on diagnosis. In the Philippines, where gout is prevalent, there is no published work on this subset of patients. This study presents the clinical characteristics of a cohort of Filipino patients with gout whose symptoms started at 30 years of age or younger. @*Methods@#The case records of all patients who fulfilled the 1977 American College of Rheumatology (ACR) criteria for gout seen in four adult rheumatology services were reviewed. We selected those whose age of onset of gout was at 30 years or younger. The demographic characteristics, medical history, laboratory parameters, and presenting manifestations were described. @*Results@#Six hundred sixty-nine records of patients with gout were reviewed; 101 (15%) fulfilled the young-onset gout criteria. The mean age of onset was 25±4.40 years (range 14-30), and the mean disease duration before diagnosis was 12.64±11.91 years. All of the patients were male and most were married; 76% were alcoholic beverage drinkers and 38% were smokers. A family history of gout was noted in 47%. Most patients (66%) were already on nonsteroidal anti-inflammatory drugs (NSAIDs), 24% on colchicine, and 14% on urate-lowering therapy before consult at the rheumatology clinic. By history, at onset, the most common pattern of joint involvement was monoarthritis (95%), affecting the ankles (60%), knees (52%), and 1st metatarsophalangeal (MTP) joint (51%). However, on the first rheumatology clinic visit, 34% of arthritis was polyarticular, more than 68% had more than three arthritis attacks per year, and there were tophi in 35%. The mean duration before visible tophi formation was 2.81±6.75 years. Around 21% had nephrolithiasis or a history thereof. The mean serum uric acid (SUA) was 9.18 mg/dL and the mean serum creatinine was 1.5 mg/dL. Thirty-seven percent had estimated glomerular filtration rate (GFR) <60 mL/min. @*Conclusion@#Young-onset gout was present in 15% of our patients and gout was familial in 47%. There was a delay in diagnosis of as long as ten years in most of the patients. On presentation at the rheumatology clinic, more than 34% had polyarticular arthritis, 35% had tophi, and 37% had low estimated GFR. This emphasizes the importance of awareness and prompt diagnosis to ensure correct treatment and prevention of complications

A randomized controlled trial of center-based and home-based exercise programs among patients with rheumatoid arthritis

Background@#Rheumatoid arthritis (RA) patients benefit from aerobic and strengthening exercises. @*Objective@#To compare the effectiveness of a home exercise program against center-based aerobic and strengthening exercises on the grip strength, endurance, function, and fatigue among patients with RA. @*Methodology@#In this assessor-blind, randomized trial, 50 RA patients were assigned to either center-based physical therapy (CPT) or home exercise program (HEP) that included aerobic and strengthening exercises performed for four weeks. The grip strength, 6-minute walk test (6MWT), health assessment questionnaire disability index (HAQ-DI), and the multidimensional assessment of fatigue (MAF) index were determined at weeks 0 (baseline), 2 and 4 weeks.

SLICC-based Phenotype of Juvenile Systemic Lupus Erythematosus in the Philippines

Objective@#To describe the clinical profile of Filipino pediatric SLE patients as determined using the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. @*Methods@#We checked which among the SLICC criteria were fulfilled by Filipino pediatric SLE patients when we examined them and their case records, as part of a nationwide genetic study on SLE conducted from October 2015 to March 2017. @*Results@#Ninety-seven (out of 321) who were diagnosed to have SLE before 19 years of age were evaluated.The mean age of the population at the time of evaluation was 19.8 ± 6.9 years. Females comprised 94% of our population. Mean age of onset was 14.4 ± 2.7 years, while the mean age of diagnosis was at 14.5 ± 2.6 years. Acute cutaneous rash was found in 87%; oral ulcers 65%; renal disorder 63%; non-scarring alopecia 61%; arthritis 58%; chronic cutaneous rash 36%; leukopenia 35%; hemolytic anemia 34%; serositis 25%; thrombocytopenia 23%, and neurologic disorder 8%. Anti-nuclear antibody was present in 85%; low complement 32%; anti-dsDNA 28%; direct Coombs’ 16%; antiphospholipid antibody 3%; and anti-Smith antibody 1%. Kidney biopsy was performed in only 14% (14/97) of patients, of whom 27% had class III histopathologic characteristic.@*Conclusions@#Filipino pediatric SLE patients typically present with mucocutaneous, renal, and musculoskeletal involvement. Cardiopulmonary and neurologic manifestations are found to be less common among them. Finally, renal biopsy is not commonly performed among these patients.

Association of sarcopenia with osteoporosis in patients with chronic obstructive pulmonary disease

Objectives@#Systemic consequence of Chronic Obstructive Pulmonary Disease (COPD) is associated with progressive loss of muscle mass and function. Preliminary studies showed presence of sarcopenia in COPD leads to reduced pulmonary function and quality of life; studies on whether this condition results in consequent loss of bone mineral density (BMD) is still inconsistent. This study aims to examine the association of sarcopenia in COPD with osteoporosis. @*Methods@#This is a post-hoc analysis of a study on forty-one (n ¼ 41) participants with COPD seen in a tertiary public hospital in Manila, Philippines who underwent pulmonary function test and dual-energy x-ray absorptiometry. Sarcopenia was defined using a Philippine-based criteria of low fat free mass index (FFMI) and low muscle strength - hand grip strength, and osteoporosis using World Health Organization T-score diagnostic criteria. @*Results@#The prevalence of osteoporosis among COPD is 44%, and 63% in COPD with sarcopenia. There was no statistical difference seen in pulmonary function variables between COPD with and without osteoporosis. Significant positive correlations were observed between Forced Expiratory Volume in 1 s, FFMI, and appendicular lean muscle with total body BMD. Sarcopenia in COPD was associated with significantly increased risk for osteoporosis. @*Conclusions@#High prevalence rate of osteoporosis, and even higher among sarcopenic Filipino COPD patients should be further studied. The findings also suggest that sarcopenia in COPD is associated with increased risk of osteoporosis, and osteoporosis alone does not seem to affect lung function.

Association of obesity and sarcopenia among adult Filipinos

OBJECTIVES: Studies on the association of obesity and sarcopenia are conflicting. Some studies showed that obesity is associated with muscle loss and frailty while others showed that lower body mass index (BMI) is associated with increased sarcopenia. To date, there is paucity of data on sarcopenia and obesity among Filipinos. This study aims to determine the association of obesity and sarcopenia among Filipinos. METHODS: This is a cross sectional analytic study comparing sarcopenic versus nonsarcopenic in terms of obesity as measured by BMI and waist circumference (WC). Filipinos older than 40 years old were included. Obesity was defined using the World Health Organization (WHO) cutoff for BMI and WC. Sarcopenia was defined as low muscle mass and low muscle strength or physical performance. Population-specific cutoff points were used to define low muscle mass, strength, and performance. RESULTS: A total of 164 participants were included. The mean age is 60.33 years. Ten (6.10%) were sarcopenic and 4 (40.00%) of them were obese. Regression analysis showed that obesity is not significantly associated with increased sarcopenia (Incidence risk ratio [IRR], 14.62; 95% confidence interval [CI], 0.96–221.92; P = 0.05). However, age (IRR, 1.15; 95% CI, 1.09–1.21; P ≤ 0.01),WC (IRR, 0.92; 95% CI, 0.85–0.99; P = 0.02), smoking (IRR, 3.17; 95% CI, 1.11–9.03; P = 0.03), and alcoholic beverage drinking (IRR, 3.71, 95% CI, 1.26–10.89; P = 0.02) were found to be significant predictors of sarcopenia. CONCLUSIONS: There is no statistically significant association between obesity and increased risk of sarcopenia among participants, however, older age, smaller WC, smoking, and alcoholic beverage drinking were significant predictors of sarcopenia.

Determination of normative reference for the definition of sarcopenia among Filipinos

BACKGROUND: At present, there is no normative value that can be used in the definition of sarcopenia in the Philippines. OBJECTIVE: We identified the reference cut-off values for: 1) muscle mass using bioimpedance analysis; 2) grip strength; 3) usual gait speed; 4) timed get-up-and-go; and 5) short physical performance battery in the Philippines in order to adapt the European Working Group on Sarcopenia in Older People (EWGSOP) criteria for the definition of sarcopenia. METHODS: Two hundred seventy six (135 males and 141 females) healthy Filipino adults, between 20 and 40 years, were included in this cross sectional study. A Fresenius Body Composition Monitor was used to measure lean tissue mass (LTM) and lean tissue index (LTI). A dynamometer was used to measure grip strength. Usual gait speed, timed get-up-and-go, and short physical performance battery were also determined. RESULT: The normative references for males and females, respectively, for LTI were 17.10 + 2.337 kg/m² and 12.63 + 2.119 kg/m²; for usual gait speed were 1.06 + 0.251 m/sec and 0.930 + 0.144 m/sec; and for grip strength were 39.76 + 7.567 kg and 26.68 + 5.243 kg. The sarcopenia cut-points for the males and females, respectively, for LTI were <12.50 kg/m² and <8.33 kg/m²; for usual gait speed were <0.55 m/sec and <0.65 m/sec; and for grip strength were <24.54 kg and <16.10 kg. CONCLUSION: This study presents cut-points for the determination of sarcopenia at-risk population among Filipinos.

Corrigendum to “Determination of normative reference for the definition of sarcopenia among Filipinos” Osteoporos. Sarcopenia 2 (2016) 186–190

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