The Use of Tocilizumab in Combination with Methotrexate in Indonesian Rheumatoid Arthritis Patients (PICTURE INA Study) | Author : Bambang Setyohadi, Harry Isbagio, Rachmat Gunadi Wachjudi, Joewono Soeroso, Handono Kalim, Deddy Nur Wachid Achadiono | Abstract | Full Text | Abstract :Background Aim of this research is to assess the efficacy and safety of tocilizumab (TCZ) in combination with methotrexate (MTX) in Indonesian patients with moderate to severe active rheumatoid arthritis (RA) who have an inadequate response to non-biologic DMARDs.
Methods This was a interventional, prospective, single arm, multicenter, study in Indonesian male or female patients aged = 18 years old, with a diagnosis of RA for > 6 months based on ACR 1987 revised criteria with moderate to severe disease activity (DAS28 score > 3.2) after = 12 weeks of non-biologic DMARDs treatment. The treatment consisted of tocilizumab, 8 mg/kg, intravenous (IV), every 4 weeks for a total of 6 infusion in combination with oral MTX (10-25 mg) every week. Efficacy was assessed based on the percentage of patients achieving low disease activity state (DAS28 < 3.2), percentage of patients achieving reduction > 1.2 point of DAS28, percentage of patients achieving remission (DAS28 < 2.6), and percentage of patients with ACR20, ACR50, and ACR70 responses. Descriptive statistics will be used for presentation of results.
Results 100% patients reached low disease activity (DAS28 = 3.2) at last study visit (week 24) and clinically significant improvement (reduction at least 1.2 units) at every visit in DAS28, both for ITT or PP patients. Remission (DAS28 < 2.6) was observed in 82.1% (ITT patients) and 93.1 % (PP patients) on last study visit. ACR20, ACR50, and ACR70 were achieved in 20%, 34%, and 34% (ITT patients), and 7%, 24%, and 62% (PP patients) on week 24. There were 3 out of 39 patients (7.69%) with adverse events (AE) and serious adverse events (SAE) that resulted in discontinuation of TCZ treatment, consisting of 1 patient with SAE of sepsis ec acquired community pneumonia, 1 patient with SAE of pneumonia tuberculosis, and 1 patient with AE of candidiasis. Most common adverse events were hepatic dysfunction (30.7%), hypercholesterolemia (23.1%), followed by arthralgia (20.5%) Twelve percent of patients needed dose modification due to elevated liver enzyme (elevated ALT/SGPT level).
Conclusion Tocilizumab seems to be efficacious and likely to have good safety profile in non- biologic DMARD nonresponsive RA patients of PICTURE INA study. |
| Clinical Manifestation and Laboratory Finding of Sclerosis Systemic Patient in Dr. Hasan Sadikin General Hospital Bandung : A Descriptive Quantitative Study | Author : Annisa Meivira Budiman, Sumartini Dewi, Marietta Shanti Prananta | Abstract | Full Text | Abstract :Background Systemic sclerosis is a chronic progressive multisystem autoimmune disease in connective tissue, characterized by its heterogeneous clinical manifestation. The purpose of this study is to give information regarding clinical manifestations and laboratory findings of systemic sclerosis patients to establish diagnosis of disease.
Methods This study was conducted using descriptive quantitative design in September-October 2016. Data was collected from medical records of patients visiting Rheumatology Clinic Dr. Hasan Sadikin General Hospital from 1 July 2015-30 June 2016 using total sampling method. The collected data were expected to comprise patient’s clinical manifestation and laboratory finding.
Results Most of patients had cutaneous 57 (100.0%) and musculoskeletal 40 (70.2%) involvement. Some of the disease manifestations were Raynaud’s phenomenon 38 (66.7%), fingertip lesion 33 (57.9%), stiffness in skin 34 (59.6%), and arthalgia 29 (50.9%). Gastrointestinal involvements were present in 29 (50.9%) patients. Renal involvement were determined from urinalysis result showed proteinuria 10 (17.5%) and hematuria 8 (14.0%), found in 24 (42.1%) patients, while pulmonary and cardiac involvements were found in 30 (52.6%) patients, acknowledged from clinical symptoms such as dyspnea 12 (21.1%). Identification of autoantibodies was found in 12 (21.1%) patients, with 10 (17.5%) patients had reactive ANA and 3 (3.5%) had positive anti-Scl70.
Conclusion Most of systemic sclerosis patients had cutaneous involvement. Renal, pulmonary, and cardiac involvement were concluded based on laboratory findings. |
| Clinical Manifestation and Laboratory Finding of Sclerosis Systemic Patient in Dr. Hasan Sadikin General Hospital Bandung : A Descriptive Quantitative Study | Author : Annisa Meivira Budiman, Sumartini Dewi, Marietta Shanti Prananta | Abstract | Full Text | Abstract :Background Systemic sclerosis is a chronic progressive multisystem autoimmune disease in connective tissue, characterized by its heterogeneous clinical manifestation. The purpose of this study is to give information regarding clinical manifestations and laboratory findings of systemic sclerosis patients to establish diagnosis of disease.
Methods This study was conducted using descriptive quantitative design in September-October 2016. Data was collected from medical records of patients visiting Rheumatology Clinic Dr. Hasan Sadikin General Hospital from 1 July 2015-30 June 2016 using total sampling method. The collected data were expected to comprise patient’s clinical manifestation and laboratory finding.
Results Most of patients had cutaneous 57 (100.0%) and musculoskeletal 40 (70.2%) involvement. Some of the disease manifestations were Raynaud’s phenomenon 38 (66.7%), fingertip lesion 33 (57.9%), stiffness in skin 34 (59.6%), and arthalgia 29 (50.9%). Gastrointestinal involvements were present in 29 (50.9%) patients. Renal involvement were determined from urinalysis result showed proteinuria 10 (17.5%) and hematuria 8 (14.0%), found in 24 (42.1%) patients, while pulmonary and cardiac involvements were found in 30 (52.6%) patients, acknowledged from clinical symptoms such as dyspnea 12 (21.1%). Identification of autoantibodies was found in 12 (21.1%) patients, with 10 (17.5%) patients had reactive ANA and 3 (3.5%) had positive anti-Scl70.
Conclusion Most of systemic sclerosis patients had cutaneous involvement. Renal, pulmonary, and cardiac involvement were concluded based on laboratory findings. |
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