Efficacy and safety of golimumab in Indian patients with rheumatoid arthritis: Subgroup data from <scp>GO</scp>‐<scp>MORE</scp> study

Pal, Sarvajeet; Veeravalli, S. Chandra Mouli; Das, Siddharth Kumar; Shobha, Vineeta; Uppuluri, Ramakrishna Rao; Dharmanand, BG; Nadkar, Milind; Hsia, Elizabeth C.; Fei, Kaiyin; Yao, Ruji; Khalifa, Ayman M.

doi:10.1111/1756-185x.12927

Cited by 6 publications

(8 citation statements)

References 23 publications

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“…In clinical trials, patient‐reported outcomes and QoL measures obtained using health‐related quality of life (HRQoL) instruments are often considered to study the impact of any intervention on RA patients 4‐8 . QoL can be calculated using several generic (EuroQoL 's Five‐Dimensional Questionnaire [EQ‐5D], Short Form [SF]‐6D, Health Utilities Index) 9 and disease‐specific questionnaires (Rheumatoid Arthritis Quality of Life) 10 .…”

Section: Introductionmentioning

confidence: 99%

Health‐related quality of life in rheumatoid arthritis: Systematic review and meta‐analysis of EuroQoL (EQ‐5D) utility scores from Asia

2021

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Introduction Region‐specific health‐related quality of life (HRQoL) scores or utility values are representative and pivotal for economic evaluations as they are influenced by the value judgment of the local population. This study systematically reviewed and pooled EuroQoL‐5 Dimension (EQ‐5D) utility scores of rheumatoid arthritis (RA) across primary studies from Asia. Methods Studies reporting EQ‐5D utility scores among adult RA patients from Asian countries were systematically searched in PubMed‐Medline, Scopus and Embase since inception through February 2020. Selected studies were systematically reviewed and study quality assessment was performed. Meta‐analysis was performed using a random‐effect model with subgroup and meta‐regression analysis to explore heterogeneity. Results Among 1391 searched articles, 37 studies with 31 983 participants were systematically reviewed and meta‐analysis was conducted among 31 studies. The pooled EQ‐5D scores and EQ‐5D visual analog score were 0.66 (95% CI 0.63‐0.69, I2 = 99.65%) and 61.21 (50.73‐71.69, I2 = 99.56%) respectively with high heterogeneity. For RA patients with no, low, moderate and high disease activity based on Disease Activity Score (DAS)‐28, the pooled EQ‐5D scores were 0.78 (0.65‐0.90), 0.73 (0.65‐0.80), 0.53 (0.32‐ 0.74), and 0.47 (0.32‐0.62), respectively. On meta‐regression, age of patients (P < .05) was positively associated and use of glucocorticoids (P < .05) was inversely associated with utility values. Conclusion Lower EQ‐5D scores were associated with severe disease activity, increasing age and female gender among RA patients. The study provides pooled EQ‐5D scores for RA patients that are useful inputs for cost‐utility studies in Asia.

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Section: Introductionmentioning

confidence: 99%

Health‐related quality of life in rheumatoid arthritis: Systematic review and meta‐analysis of EuroQoL (EQ‐5D) utility scores from Asia

2021

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“…Overall, the report indicates that in Indian RA patients who are treated with etanercept (which incidentally has the lowest TB reactivation based on previous data), also report a 5% rate of TB reactivation from the latent stage . In the Indian subset of golimumab development phase 3 program (GO‐MORE trial part 1), none of the patients on golimumab ( n = 105) therapy reported TB reactivation or overt TB infection …”

Section: Latent Tuberculosis In Rheumatic Disease Patients Opting Formentioning

confidence: 83%

“…66,67 In the Indian subset of golimumab development phase 3 program (GO-MORE trial part 1), none of the patients on golimumab (n = 105) therapy reported TB reactivation or overt TB infection. 68 Low predictive value and sensitivity of screening tests Mandatory screening for LTBI using TST and IGRA has reduced the risk for TB flare but has not completely eradicated it. One of the drawbacks of these tests is that their predictive value is only 1-2% for active TB development.…”

Section: Latent Tuberculosis In Rheumatic Disease Patients Opting Formentioning

confidence: 99%

Tuberculosis and biologics in rheumatology: A special situation

et al. 2017

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India has a huge patient burden of rheumatic diseases (RDs) including rheumatoid arthritis. The use of biologics has transformed the treatment paradigm for RD; however, biologic treatment-related infections (especially tuberculosis [TB]) are an area of potential concern for TB-endemic nations like India. Anti-tumor necrosis factor (TNF) therapy impairs the physiological TNF-mediated signaling and may cause reactivation and dissemination of latent TB infection (LTBI). Careful screening is, thus, crucial in RD patients who are about to commence anti-TNF treatment. To date, there is no consensus available for the screening, evaluation and treatment of LTBI as well as on the drug dosage and duration regimen (monotherapy or combination therapy) in the Indian population. An evidence-based algorithm for LTBI screening and management in RD patients undergoing biologic disease-modifying anti-rheumatic drug therapy is suggested in this review for Indian rheumatologists. The proposed algorithm guides physicians through a step-wise screening approach, including medical history, tuberculin skin test, interferon gamma release assay, chest radiograph and management of LTBI with isoniazid therapy or its combination with rifampicin. Further, the provided algorithm can aid the national bodies (such as National TB Control Program) in formulating recommendations for LTBI in this high-risk population.

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“…Recently, a study evaluating efficacy and safety of GLM in patients from India had shown the drug as effective and safe in patients with systemic manifestation of rheumatoid arthritis. [ 12 ] However, there are lack of data on usage of GLM in the management of uveitis from India.…”

Section: Discussionmentioning

confidence: 99%

A case of human leukocyte antigen B-27-associated ocular hypotony successfully treated with golimumab

Majumder

Lakra

Yamuna

et al. 2018

Indian J Ophthalmol

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A 42-year-old male presented to us after an episode of acute anterior human leukocyte antigen (HLA)-B27-associated uveitis, and intraocular pressure (IOP) in the right eye was 4 mmHg. Ultrasound biomicroscopy revealed ciliary body edema with supraciliary effusion. He was on a frequent topical corticosteroid, and oral steroid in addition to receiving a periocular injection depot corticosteroid 20 days back. He was started on treatment with subcutaneous golimumab (GLM). After a month, his IOP in the right eye was 14 mm of Hg with UBM showing resolution of ciliary body edema. GLM can be useful in the management of steroid-resistant cases of HLA B-27-associated ocular hypotony.

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Efficacy and safety of golimumab in Indian patients with rheumatoid arthritis: Subgroup data from GO‐MORE study

Abstract: The efficacy and safety results with add-on golimumab were consistent between RA patients from India and outside India, despite high baseline disease activity in the Indian patients.

Cited by 6 publications

References 23 publications

Health‐related quality of life in rheumatoid arthritis: Systematic review and meta‐analysis of EuroQoL (EQ‐5D) utility scores from Asia

Health‐related quality of life in rheumatoid arthritis: Systematic review and meta‐analysis of EuroQoL (EQ‐5D) utility scores from Asia

Tuberculosis and biologics in rheumatology: A special situation

A case of human leukocyte antigen B-27-associated ocular hypotony successfully treated with golimumab

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