Safety and Efficacy of Golimumab in Indian Patients with Active Spondyloarthritis of Ankylosing Spondylitis or Psoriatic Arthritis: A Multicenter, Noncomparative, Open-Label, Real-World Study.

BACKGROUND: The safety and efficacy of tumor necrosis factor-α (TNF-α) inhibitor therapy for most common rheumatological diseases, ankylosing spondylitis (AS), and psoriatic arthritis (PsA) in controlled clinical trials is well-studied. This study evaluated subcutaneous (SC) golimumab in Indian patients with active spondyloarthritis (SpA) of AS or PsA in a real-world setting. MATERIALS AND METHODS: This phase 4, multicenter, prospective, non-comparative, interventional, 24-week study was performed in patients (age ≥18 years) with active SpA of AS or PsA (NCT03733925). Golimumab 50 mg was given subcutaneously to the patients every 4 weeks. Safety was assessed. The proportion of patients with AS and PsA achieving ≥20% improvement in the Assessment of SpA International Society 20 (ASAS20) criteria and American College of Rheumatology 20 (ACR20) responses, respectively, at weeks 14 and 24 were efficacy endpoints. RESULTS: Of the 100 patients enrolled (men: 78 [78.0%]; mean age: 36.7 [12.02] years), 94 (94.0%) patients completed the study. Treatment-emergent adverse events with golimumab were observed in 29/100 (29.0%) patients, and nasopharyngitis and upper respiratory tract infection (5.0% each) were the most common (≥5%). Deaths were not reported. At week 14, 74.5% (95% confidence interval [CI]: 59.7; 86.1%) of patients with AS and 84.6% (95% CI: 69.5; 94.1%) of patients with PsA achieved ASAS20 and ACR20 responses, which were sustained at week 24 (ASAS20: 66.0% [95% CI: 50.7, 79.1%]; ACR20: 93.2% [95% CI: 81.3, 98.6%]), respectively. CONCLUSION: Golimumab (50 mg) administered subcutaneously was safe and effective in Indian patients with active SpA of AS or PsA during the 24-week study period with no new safety signals.

Lipid Association of India 2023 update on cardiovascular risk assessment and lipid management in Indian patients: Consensus statement IV.

OBJECTIVE: In 2016, the Lipid Association of India (LAI) developed a cardiovascular risk assessment algorithm and defined low-density lipoprotein cholesterol (LDL-C) goals for prevention of atherosclerotic cardiovascular disease (ASCVD) in Indians. The recent refinements in the role of various risk factors and subclinical atherosclerosis in prediction of ASCVD risk necessitated updating the risk algorithm and treatment goals. METHODS: The LAI core committee held twenty-one meetings and webinars from June 2022 to July 2023 with experts across India and critically reviewed the latest evidence regarding the strategies for ASCVD risk prediction and the benefits and modalities for intensive lipid lowering. Based on the expert consensus and extensive review of published data, consensus statement IV was commissioned. RESULTS: The young age of onset and a more aggressive nature of ASCVD in Indians necessitates emphasis on lifetime ASCVD risk instead of the conventional 10-year risk. It also demands early institution of aggressive preventive measures to protect the young population prior to development of ASCVD events. Wide availability and low cost of statins in India enable implementation of effective LDL-C-lowering therapy in individuals at high risk of ASCVD. Subjects with any evidence of subclinical atherosclerosis are likely to benefit the most from early aggressive interventions. CONCLUSIONS: This document presents the updated risk stratification and treatment algorithm and describes the rationale for each modification. The intent of these updated recommendations is to modernize management of dyslipidemia in Indian patients with the goal of reducing the epidemic of ASCVD among Indians in Asia and worldwide.

Esophageal Stricture and Dermal Pathology Related to Compound Heterozygous Mutations in the TNXB Gene.

The Ehlers-Danlos' syndrome (EDS) constitutes a group of connective tissue disorders that are clinically and genetically heterogeneous. Mutations in the TNXB gene have been recognized as pathogenic causing classical-like EDS due to tenascin-X deficiency. Here, we have reported a unique case of compound heterozygous mutation in TNXB gene leading to esophageal stricture and scarred skin in a 7-year-old boy who presented to us with impacted foreign body in esophagus. The child was also having tendency to atrophic skin scarring secondary to trivial trauma.

Fibromyalgia and mental health in rheumatoid arthritis: a cross-sectional prevalence study from the COVID-19 pandemic.

OBJECTIVES: This study evaluated the prevalence of fibromyalgia (FM), anxiety and depression in patients with rheumatoid arthritis (RA) and their effects on the clinical parameters of RA during the COVID-19 pandemic. DESIGN: Cross-sectional, outpatient clinic, observational, non-interventional. SETTING: Single-centre, tertiary care, multispecialty, service and research hospital, north-central India. PARTICIPANTS: Adult patients with RA, controls. RESULTS: This cross-sectional study included 200 patients with RA diagnosed with the American College of Rheumatology/European League Against Rheumatism 2010 (ACR) criteria and 200 controls. FM was diagnosed using the revised 2016 ACR FM Criteria. Disease activity, quality of life and functional disability in patients with RA were assessed using multiple Disease Activity Scores. The presence of depression and anxiety was determined using the Hospital Anxiety and Depression Scale. FM was present in 31% of patients with RA compared with 4% of controls in our study. Patients with RA with FM were older, predominantly females with longer disease duration, and more likely to be on steroids. Patients with RA with FM had a higher disease activity, and none of our RA with FM patients were in remission. The multivariable analysis found FM to be an independent predictor of the Simplified Disease Activity Index for RA. Patients with RA with FM had worse functional ability and poorer quality of life. The prevalence of anxiety and depression was 12.5% and 30%, significantly higher in RA with FM patients. CONCLUSION: During the COVID-19 pandemic, around one-third of our study patients had FM and depression, significantly higher than pre-COVID-19 times. Thus, mental health assessment should be incorporated into the routine management of patients with RA.

Validation of Hindi version of the Pittsburg Sleep Quality Index.

BACKGROUND: Sleep quality is poorly understood in the Indian population. Lack of a suitable tool to assess sleep quality in Hindi language is the main reason behind this. Pittsburg sleep quality index (PSQI) is widely used in different population groups to assess subjective sleep quality over last one month. OBJECTIVES: To assess the reliability and validity of the Hindi translated version of Pittsburgh Sleep Quality Index (PSQI-H). gt;Methods: The PSQI-H was developed from PSQI according to following steps: (a) translation, (b) back-translation, (c) comparison between translation and back-translation performed by a group of experts, and (d) pre-pilot test in intended population. The PSQI-H was applied to 105 bilingual individuals knowing Hindi and English. The internal consistency of PSQI-H was assessed by Cronbach's alpha. For test-retest reliability assessment intraclass correlation coefficient (ICC) was measured between PSQI-H at baseline and PSQI after 4 weeks. The Pearson's coefficient was used to assess the correlation between the score of the questions and the PSQI-H scores. RESULTS: The seven components of PSQI-H shows acceptable level of internal consistency with Cronbach's alpha of 0.776. There is good test-retest reliability between PSQI-H and PSQI as measured by ICC of 0.979. The score of individual items and global scores of PSQI-H were highly correlated with each other (p< 0.001). The mean of the seven individual components score and global scores of PSQI-H at baseline and original PSQI after 4 weeks did not differ significantly. CONCLUSION: This study results demonstrate that the PSQI-H is a valid and reliable instrument for the assessment of sleep quality. PSQI-H can be used for the assessment of sleep quality in the predominantly Hindi speaking population.

Screening for Hydroxychloroquine Retinal Toxicity in Indian Patients.

OBJECTIVE: Several studies have reported hydroxychloroquine (HCQ) retinal toxicity in East Asian patients. However, at present, there are limited data from Indian patients. The aim of this study was to investigate the prevalence and pattern of HCQ retinal toxicity in Indian population and to see if screening protocol for retinal toxicity in Indian patients should be any different to others. METHODS: This was a cross-sectional study involving adult patients with autoimmune rheumatic diseases who had received HCQ for at least 5 years or a cumulative dose of at least 500 g. Retinal toxicity was evaluated using fundus examination, visual fields 10-2 and 30-2 protocol, and spectral domain optical coherence tomography. RESULTS: Of 110 patients screened, retinal toxicity was found in 7 patients (6.36%). A parafoveal pattern was found in 4 patients, whereas a mixed parafoveal and perifoveal pattern was found in 3 patients. None of the patients had isolated perifoveal pattern. Except for the one patient, all the patients with retinal toxicity had more than 10 years (mean, 13 ± 4.89 years; range, 5-20 years) of HCQ usage with a mean cumulative dose of 1573.7 ± 771.5 g. The mean daily dose was 5 ± 1.6 mg/kg per day. CONCLUSIONS: Hydroxychloroquine retinal toxicity is more common than previously recognized in patients who have used the drug for more than 5 years. The toxicity manifests as a parafoveal or a mixed parafoveal and perifoveal pattern in Indian patients.

Anti-drug antibodies and low serum trough infliximab levels correlate with disease activity measures in spondyloarthritis patients on an as-needed infliximab treatment.

AIM: In India, many centers use infliximab at lower doses of 3-5 mg/kg without the loading dose for spondyloarthritis (SpA) patients. It is then continued on an as-required basis, rather than a fixed schedule. Our study was undertaken to see if the trough drug levels and anti-drug antibodies in patients with SpA treated with as-needed infliximab dosing correlated with the disease activity measures. METHODS: Thirty-five adult SpA patients in the age group 18-70 years were recruited. They had received three or more infusions of infliximab at 3-5 mg/kg over the past 6 to 12 months. Patient's serum tumor necrosis factor-α, trough infliximab levels and anti-drug antibodies were measured by enzyme-linked immunosorbent assay technique. The disease activity was quantified by Ankylosing Spondylitis Disease Activity Score - erythrocyte sedimentation rate/ C-reactive protein (ASDAS-ESR/CRP) scores. Correlation between quantitative variables was analyzed by the Spearman's correlation assay. The difference in mean trough infliximab and ASDAS between the drug antibody positive and negative patients was assessed using the Mann-Whitney U test. RESULTS: There was a significant negative correlation between the trough infliximab levels and the ASDAS-ESR (rs = -0.57, P < 0.01) and ASDAS-CRP scores (rs = -0.53, P < 0.01). Anti-drug antibodies were positive in 68.7% of the patients and in comparison to the antibody negative patients, had significantly higher ASDAS-ESR and ASDAS-CRP scores. CONCLUSIONS: Spondyloarthritis patients on low-dose, as-needed infliximab therapy, have both the trough infliximab and anti-drug antibodies correlate significantly with the measures of disease activity. We hypothesize that trough infliximab levels and anti-drug antibodies may be used to predict a suboptimal response due to secondary resistance in SpA patients.

Tuberculosis and biologics in rheumatology: A special situation.

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.

Lack of clinical association with antibodies to ribosomal P proteins in Indian patients with systemic lupus erythematosus.

OBJECTIVE: We examined the prevalence and clinical association of the antiribosomal antibodies in our cohort of patients with systemic lupus erythematosus (SLE). METHODS: IgG antiribosomal P protein (anti-P) antibodies were detected in 202 consecutive patients with SLE and 212 age and sex matched healthy subjects by an in-house ELISA, using the 22-mer C-terminal peptide. In 13 patients, IgG anti-P antibodies were also tested in paired cerebrospinal fluid (CSF) and sera samples. Clinical variables were compared in the antibody-positive and negative groups using appropriate statistical tests. RESULTS: Of the 202 patients, 15 were male. Their median age was 30 years and the median disease duration was 36 months. Thirty-one patients (15.35%) were positive for IgG anti-P antibodies, of which 24 were also positive by Western blot. No association with SLE Disease Activity Index, nervous system disease, nephritis, hepatitis, skin disease, arthritis, and juvenile onset disease could be demonstrated. Levels of IgG anti-P antibodies in CSF were 100-fold less compared to levels in serum, and correlated well with the latter (r = 0.86; p < 0.01). CONCLUSION: The prevalence of IgG anti-P antibodies is similar in Indian and Caucasian patients with SLE. No association with specific organ involvement or age at onset could be demonstrated.