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All Journal Acta Interna : The Journal of Internal Medicine Journal of the Medical Sciences (Berkala Ilmu Kedokteran) Indonesian Journal of Rheumatology
Deddy Nur Wachid Achadiono
Division Of Rheumatology, Department Of Internal Medicine, Faculty Of Medicine, Public Health And Nursing, Universitas Gadjah Mada/ Dr. Sardjito General Hospital
Health Professions Immunology & microbiology Medicine & Pharmacology Neuroscience

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Journal : Indonesian Journal of Rheumatology

 1 
The Use of Tocilizumab in Combination with Methotrexate in Indonesian Rheumatoid Arthritis Patients (PICTURE INA Study) Setyohadi, Bambang; Isbagio, Harry; Wachjudi, Rachmat Gunadi; Soeroso, Joewono; Kalim, Handono; Achadiono, Deddy Nur Wachid
Indonesian Journal of Rheumatology Vol 10, No 1 (2018)
Publisher : Indonesian Rheumatology Association

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (577.723 KB)

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.   Keywords: Rheumatoid Arthritis, Tocilizumab, DMARD, DAS28
The Use of Tocilizumab in Combination with Methotrexate in Indonesian Rheumatoid Arthritis Patients (PICTURE INA Study) Bambang Setyohadi; Harry Isbagio; Rachmat Gunadi Wachjudi; Joewono Soeroso; Handono Kalim; Deddy Nur Wachid Achadiono
Indonesian Journal of Rheumatology Vol. 10 No. 1 (2018): Indonesian Journal of Rheumatology
Publisher : Indonesian Rheumatology Association

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (577.723 KB) | DOI: 10.37275/ijr.v10i1.91

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.   Keywords: Rheumatoid Arthritis, Tocilizumab, DMARD, DAS28
Correlation Between Mex-Sledai and Mean Platelet Volume In Systemic Lupus Erythematosus Patients Ayu Paramaiswari; Dody Hendro Susilo; Deddy Nur Wachid Achadiono
Indonesian Journal of Rheumatology Vol. 12 No. 2 (2020): Indonesian Journal of Rheumatology
Publisher : Indonesian Rheumatology Association

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/ijr.v12i2.158

Abstract

A B S T R A C TBackground. Systemic lupus erythematosus (SLE) is a chronic autoimmunedisease which has a variety of clinical phenotypes with a complex clinical course.The clinical phenotypes are highly variable which can be characterized by acuteattacks, active periods, controllable or remission. Mean platelet volume (MPV) is astraightforward accessible indicator of platelet activity and is associated withsystemic inflammation. The routine usage of MPV as markers for disease activityin SLE remains problematic. Early detection of disease progression is pivotal in themanagement of SLE for obtaining better outcomes. Objective. The study aimed toconfirm that the measurement of the disease severity in patients with SLE usingMex-SLEDAI has a negative correlation with the decrease of MPV value. Methods.This cross-sectional analytic descriptive study was conducted using secondary datafrom the medical records of patients with SLE older than 18 years of age who werenot taking antiplatelets in the Internal Medicine policlinic of Dr. Sardjito GeneralHospital in 2018. Patients with a previous history of cardiovascular andcerebrovascular events, malignancies, receiving a treatment for infections,including sepsis, chronic infections (i.e. tuberculosis, cytomegalovirus, herpessimplex, herpes zoster), HIV, hepatitis B or hepatitis C, and incomplete data ofmedical record were excluded. The correlation between SLEDAI Mex and MPVvalues was evaluated using the Spearman's correlation test. Results. Sixty-sevensubjects (65 women, 2 men) aged 34 ± 11 years were recruited in the study. Themedian duration of diagnosis was 38,2 ± 45,7 months. Arthritis, skin rash andphotosensitivity were identified in 81,1%, 53,7%, and 46,3% of patients,respectively. The Mex-SLEDAI score ranged from 0 to 16. The average of MPV valueis 9.73 ± 1.21 fL. A significant correlation between MPV and SLEDAI Mex wasobserved (p = 0.03 (p <0.05), r = -0.255). Conclusion. The more severe SLE diseaseactivity (based on the Mex-SLEDAI scoring), the more negative correlation with theMPV value.
Co-Authors Andika Ilham Rahmatullah Anggi Wahyu Nugroho Asdie, Achmad Husain Ayu Paramaiswari Ayu Paramaiswari Ayu Paramaiswari Bambang Setyohadi Bambang Setyohadi Bambang Udji Djoko Riyanto, Bambang Udji Djoko Dody Hendro Susilo Eko Nugroho Handono Kalim Handono Kalim Harry Isbagio Harry Isbagio I Dewa Putu Pramantara Joewono Soeroso Joewono Soeroso Muhipah Muhipah Nyoman Kertia Rachmat Gunadi Wachjudi Rengganis, Anggraeni Ayu Retnowulan, Heni Tiara Putri Utami Yulyani Werdhiningsih