Aseptic pyomyositis in rheumatoid arthritis treated with corticosteroid and DMARDs.

Pyomyositis is a purulent infection of skeletal muscle that is mostly observed in tropical countries. Aseptic pyomyositis is a rare, potentially life-threatening disorder characterized by the formation of sterile pus in muscle. We present a case of 53-years old female, diagnosed case of seropositive rheumatoid arthritis, presented with pain and swelling of the right calf muscle for 2 weeks. There was no history of fever, cough, skin erythema, no history of prolonged standing or immobility, or fetal loss. The diagnosis was made as rheumatoid arthritis with autoimmune pyomyositis, and the patient was treated with oral prednisolone 1mg/kg body weight in tapering dose, cs DMARDS, (methotrexate 25 mg once a week, and leflunomide 20mg daily hydroxychloroquine 200 mg daily orally) and another supportive treatment along with surgical drainage of pus was done. There was complete resolution of the initial lesion and remission of the primary disease in 3 months.

Characteristics and risk factors of COVID-19 breakthrough infections in Idiopathic Inflammatory Myopathies: Results from the COVAD study.

OBJECTIVES: To explore prevalence, characteristics and risk factors of COVID-19 breakthrough infections (BIs) in idiopathic inflammatory myopathies (IIM) using data from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. METHODS: A validated patient self-reporting e-survey was circulated by the COVAD study group to collect data on COVID-19 infection and vaccination in 2022. BIs were defined as COVID-19 occurring ≥14 days after 2 vaccine doses. We compared BIs characteristics and severity among IIMs, other autoimmune rheumatic and non-rheumatic diseases (AIRD, nrAID), and healthy controls (HC). Multivariable Cox regression models assessed the risk factors for BI, severe BI and hospitalisations among IIMs. RESULTS: Among 9449 included response, BIs occurred in 1447 (15.3%) respondents, median age 44 years (IQR 21), 77.4% female, and 182 BIs (12.9%) occurred among 1406 IIMs. Multivariable Cox regression among IIMs showed age as a protective factor for BIs [Hazard Ratio (HR)=0.98, 95%CI = 0.97-0.99], hydroxychloroquine and sulfasalazine use were risk factors (HR = 1.81, 95%CI = 1.24-2.64, and HR = 3.79, 95%CI = 1.69-8.42, respectively). Glucocorticoid use was a risk factor for severe BI (HR = 3.61, 95%CI = 1.09-11.8). Non-White ethnicity (HR = 2.61, 95%CI = 1.03-6.59) was a risk factor for hospitalisation. Compared with other groups, patients with IIMs required more supplemental oxygen therapy (IIM = 6.0% vs AIRD = 1.8%, nrAID = 2.2%, and HC = 0.9%), intensive care unit admission (IIM = 2.2% vs AIRD = 0.6%, nrAID, and HC = 0%), advanced treatment with antiviral or monoclonal antibodies (IIM = 34.1% vs AIRD = 25.8%, nrAID = 14.6%, and HC = 12.8%), and had more hospitalisation (IIM = 7.7% vs AIRD = 4.6%, nrAID = 1.1%, and HC = 1.5%). CONCLUSION: Patients with IIMs are susceptible to severe COVID-19 BI. Age and immunosuppressive treatments were related to the risk of BIs.

Flares in IIMs and the timeline following COVID-19 vaccination: a combined analysis of the COVAD-1 and -2 surveys.

OBJECTIVES: Disease flares in the post-coronavirus disease 2019 (COVID-19) vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs). METHODS: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022, respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history and vaccination details. Flares of IIMs were defined as (a) patient self-reported, (b) immunosuppression (IS) denoted, (c) clinical sign directed and (d) with >7.9-point minimal clinically significant improvement difference worsening of Patient-Reported Outcomes Measurement Information System (PROMIS) PROMISPF10a score. Risk factors of flares were analysed using regression models. RESULTS: Of 15 165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians) and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7% and 19.6% patients by definitions (a) to (d), respectively, with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR 1.2; 95% CI 1.03, 1.6, P = 0.025) were prone to flares, while those receiving rituximab (OR 0.3; 95% CI 0.1, 0.7, P = 0.010) and AZA (OR 0.3, 95% CI 0.1, 0.8, P = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in IS. Asthma (OR 1.62; 95% CI 1.05, 2.50, P = 0.028) and higher pain visual analogue score (OR 1.19; 95% CI 1.11, 1.27, P < 0.001) were associated with disparity between self-reported and IS-denoted flares. CONCLUSION: A diagnosis of IIMs confers an equal risk of flares in the post-COVID-19 vaccination period to AIRDs, with active disease, female gender and comorbidities conferring a higher risk. Disparity between patient- and physician-reported outcomes represents a future avenue for exploration.

COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study.

OBJECTIVES: We investigated COVID-19 vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. METHODS: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares (DF), and AID-related treatment modifications were analyzed upon diagnosis of AID versus healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine. RESULTS: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, p= 0.01; minor AE 40% vs 25.9%, p= 0.03; major AE 17.5% vs 4.6%, p< 0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC with respect to AE. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18.3% of age- and disease-matched non-pregnant and non-breastfeeding patients (n = 262). All pregnant/breastfeeding patients who experienced a DF were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively. CONCLUSION: This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods, helping overcome hesitant attitudes, as the benefits for the mother and the fetus by passive immunization appear to outweigh potential risks.

Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study.

Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb-June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35-58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2-7.0, p < 0.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period.

Flares in autoimmune rheumatic diseases in the post-COVID-19 vaccination period-a cross-sequential study based on COVAD surveys.

OBJECTIVE: Flares of autoimmune rheumatic diseases (AIRDs) following COVID-19 vaccination are a particular concern in vaccine-hesitant individuals. Therefore, we investigated the incidence, predictors and patterns of flares following vaccination in individuals living with AIRDs, using global COVID-19 Vaccination in Autoimmune Diseases (COVAD) surveys. METHODS: The COVAD surveys were used to extract data on flare demographics, comorbidities, COVID-19 history, and vaccination details for patients with AIRDs. Flares following vaccination were identified as patient-reported (a), increased immunosuppression (b), clinical exacerbations (c) and worsening of PROMIS scores (d). We studied flare characteristics and used regression models to differentiate flares among various AIRDs. RESULTS: Of 15 165 total responses, the incidence of flares in 3453 patients with AIRDs was 11.3%, 14.8%, 9.5% and 26.7% by definitions a-d, respectively. There was moderate agreement between patient-reported and immunosuppression-defined flares (K = 0.403, P = 0.022). Arthritis (61.6%) and fatigue (58.8%) were the most commonly reported symptoms. Self-reported flares were associated with higher comorbidities (P = 0.013), mental health disorders (MHDs) (P < 0.001) and autoimmune disease multimorbidity (AIDm) (P < 0.001).In regression analysis, the presence of AIDm [odds ratio (OR) = 1.4; 95% CI: 1.1, 1.7; P = 0.003), or a MHD (OR = 1.7; 95% CI: 1.1, 2.6; P = 0.007), or being a Moderna vaccine recipient (OR = 1.5; 95% CI: 1.09, 2.2; P = 0.014) were predictors of flares. Use of MMF (OR = 0.5; 95% CI: 0.3, 0.8; P = 0.009) and glucocorticoids (OR = 0.6; 95% CI: 0.5, 0.8; P = 0.003) were protective.A higher frequency of patients with AIRDs reported overall active disease post-vaccination compared with before vaccination (OR = 1.3; 95% CI: 1.1, 1.5; P < 0.001). CONCLUSION: Flares occur in nearly 1 in 10 individuals with AIRDs after COVID vaccination; people with comorbidities (especially AIDm), MHDs and those receiving the Moderna vaccine are particularly vulnerable. Future avenues include exploring flare profiles and optimizing vaccine strategies for this group.

Vaccine hesitancy decreases in rheumatic diseases, long-term concerns remain in myositis: a comparative analysis of the COVAD surveys.

OBJECTIVE: COVID-19 vaccines have a favorable safety profile in patients with autoimmune rheumatic diseases (AIRDs) such as idiopathic inflammatory myopathies (IIMs); however, hesitancy continues to persist among these patients. Therefore, we studied the prevalence, predictors and reasons for hesitancy in patients with IIMs, other AIRDs, non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs), using data from the two international COVID-19 Vaccination in Autoimmune Diseases (COVAD) e-surveys. METHODS: The first and second COVAD patient self-reported e-surveys were circulated from March to December 2021, and February to June 2022 (ongoing). We collected data on demographics, comorbidities, COVID-19 infection and vaccination history, reasons for hesitancy, and patient reported outcomes. Predictors of hesitancy were analysed using regression models in different groups. RESULTS: We analysed data from 18 882 (COVAD-1) and 7666 (COVAD-2) respondents. Reassuringly, hesitancy decreased from 2021 (16.5%) to 2022 (5.1%) (OR: 0.26; 95% CI: 0.24, 0.30, P < 0.001). However, concerns/fear over long-term safety had increased (OR: 3.6; 95% CI: 2.9, 4.6, P < 0.01). We noted with concern greater skepticism over vaccine science among patients with IIMs than AIRDs (OR: 1.8; 95% CI: 1.08, 3.2, P = 0.023) and HCs (OR: 4; 95% CI: 1.9, 8.1, P < 0.001), as well as more long-term safety concerns/fear (IIMs vs AIRDs - OR: 1.9; 95% CI: 1.2, 2.9, P = 0.001; IIMs vs HCs - OR: 5.4 95% CI: 3, 9.6, P < 0.001). Caucasians [OR 4.2 (1.7-10.3)] were likely to be more hesitant, while those with better PROMIS physical health score were less hesitant [OR 0.9 (0.8-0.97)]. CONCLUSION: Vaccine hesitancy has decreased from 2021 to 2022, long-term safety concerns remain among patients with IIMs, particularly in Caucasians and those with poor physical function.

Tofacitinib as an Adjunct Immunomodulator for Treatment of a Patient with Severe COVID-19: A Case Report.

Severe coronavirus disease 2019 can be associated with progressive respiratory failure. In addition to respiratory support and other supportive care, use of corticosteroids has shown to improve outcome. Despite the use of steroids, a significant proportion of patients progressively worsen. Adjunct immunomodulators have been studied in addition to steroids in these patients. Here we present a successful use of tofacitinib, a Janus Kinase inhibitor, in conjunction with dexamethasone for a patient with rapid worsening of respiratory status and with high level of serum inflammatory biomarkers.

Diagnosis and management of gout by clinicians in Nepal: a web-based survey.

Patients with gout in Nepal are usually attended by medical graduates, family medicine, internists, and orthopedic surgeons. The study aimed to evaluate knowledge, attitude, and practice (KAP) of point-of-care clinicians of Nepal regarding diagnosis and management of gout and assess the quality of treatment provided to the patients. A web-based descriptive, cross-sectional study was conducted among doctors managing gout patients. The questionnaire comprises 38 multiple choice questions; 9 questions for demographic data, 8, 11, and 10 questions each for knowledge, attitude, and practice, respectively. A pilot study was conducted to observe comprehensibility of the questionnaire before subjecting it to the participants. Ethical approval was obtained from review committee of National Center for Rheumatic diseases, Nepal. Simple descriptive statistics was used to describe the correct responses. Among 1200 clinicians invited, 32% (380) participated in the survey. Maximum respondents were of age group 25-45 years (82%) with majority being internists (43%). Although only 32% understood that the disease is not curable, knowledge regarding disease was acceptable in majority (60-90%). Around 83% denied attending any gout-related seminars and 34% denied being updated with the recent guidelines. The majority of postgraduates (72%) managed the cases themselves. Although there was acceptable practice accuracy on use of therapy for acute attacks (75%), target urate levels (57%), and use of urate-lowering agents (92%), they lacked in adequate screening of co-morbidities and initiation of long-term treatment. The point-of-care clinicians have adequate knowledge to diagnose and treat acute events. However, there is poor reflection in practice and frequent update of treatment guidelines is warranted.

Late Onset Dipeptidyl Peptidase -4 Inhibitor Associated Seronegative Rheumatoid Arthritis.

Drug-induced arthritis is not an uncommon scenario. DPP-4 inhibitors could potentially cause adverse-events mediated by cytokine-induced inflammation leading to arthritis. The activity of the DPP-4 enzyme could be inversely related to the development of rheumatoid arthritis, explaining the increased inflammatory activity with its inhibition by a drug. We discuss a 72-year-old gentleman with twenty-three years of history of type 2 diabetes mellitus, who after 6 years of treatment with a DPP-4 inhibitor, developed features of inflammatory arthritis and fulfilled the criteria for seronegative rheumatoid; which eventually subsided after stopping the drug. Keywords: DDP-4 inhibitor; diabetes mellitus; Nepal; rheumatoid arthritis; seronegative.

A Study of Metabolic Parameters in Patients with Gout: A Single Center Study from Nepal.

BACKGROUND AND AIMS: To study the prevalence of deranged metabolic parameters in patients with gout. METHODS: This was a prospective, cross-sectional observational study conducted at a tertiary level rheumatology center in Nepal. Patients over 18 years and diagnosed as gout using the ACR/EULAR 2015 classification criteria were included in the study. Known cases of chronic kidney disease, liver disease and heart diseases were excluded. Baseline demographic data along with records of weight, waist circumference, lipid profile, glucose profile, blood pressure measurement, serum uric acid level and inflammatory markers were taken. Diagnosis of metabolic syndrome (MS) was made according to the National Cholesterol Education Program criteria. Approval was obtained from the ethical review board of the National Center for Rheumatic Diseases. RESULTS: A total of 523 patients with gout were enrolled in the study, out of which 97.0% were male. The mean age at diagnosis was 49.1±12.8 years. Most of the patients were overweight with a mean BMI of 27.0±3.6 kg/m2. About 8.1% had preexisting diabetes mellitus, 24.6% had hypertension, 5.1% had hypothyroidism and 45.1% had dyslipidemia. Patients fulfilling 2 out of 5 criteria of MS were 60.6% whereas 30.6% fulfilled 3 out of 5 criteria. CONCLUSION: Gout was commonly observed in middle-aged men. The prevalence of metabolic syndrome and its components was high in patients with gout. Management of gout should also include screening and management of the metabolic syndrome.

Adverse Events Profile of Low-dose Methotrexate in Nepalese Patients with Rheumatoid Arthritis: an Observational Study.

BACKGROUND: Methotrexate is considered as the anchor drug for the treatment of rheumatoid arthritis. However, various adverse effects limit its use leading to frequent discontinuation of treatment. This study aimed to evaluate the common adverse effects of methotrexate in patients with rheumatoid arthritis. METHODS: A prospective observational study was conducted at National Center for Rheumatic Diseases from June 2018 to May 2019 among patients with rheumatoid arthritis using methotrexate monotherapy. Laboratory tests like liver function tests, renal function tests, complete blood count, C-reactive protein, erythrocyte sedimentation rate were done at baseline and every 3 months. Data on patients' comorbidities, disease activity and side effects of drug were collected on every follow- up. Statistical analysis was carried out with the help of SPSS 23.0. RESULTS: Out of 232 patients experiencing at least one adverse effect while on methotrexate monotherapy, 87.5% were female and mean age was 46.9±10.8 years. The mean dose of methotrexate was 16.6 ± 3.9 mg/week with the most frequently used dose of 20mg/week. Among the variety of adverse reaction observed, the most common was transaminitis (75.0%) with approximately 50.0% as isolated liver function abnormality, followed by nausea (19.4%), anorexia (12.9%), leukopenia (12.5%), oral ulcer (8.2%) and psychological intolerance (4.7%). Multiple regression analysis showed significant predictive value of body mass index for transaminitis (p-value 0.007). CONCLUSIONS: Asymptomatic liver function test derangement was the most frequent adverse-effect of methotrexate observed, whereas nausea and anorexia were the most common patient reported events. The frequent dose associated with side-effects in Nepalese patients was around 20mg/week.

Clinico-demographic Profile of Undifferentiated Inflammatory Arthritis Patients.

BACKGROUND: Undifferentiated inflammatory arthritis is a group of inflammatory joint diseases that do not fulfil the classification criteria for any other rheumatic or connective tissue disorders. This study aims to describe the clinical, demographic and serological features of undifferentiated inflammatory arthritis cases presenting at a tertiary level rheumatology centre from Nepal. METHODS: A descriptive cross-sectional study conducted at National Centre for Rheumatic Diseases, Kathmandu, Nepal which represents a midterm analysis of the undifferentiated inflammatory arthritis registry maintained at the centre. Patients more than 18 years of age, who consented for the study having least one swollen or tender joint were enrolled. Ethical approval was obtained from Nepal Health Research Council. RESULTS: A total of 1120 patients were enrolled in the study out of which 941 (84%) were females. The mean age at diagnosis was 46.0±12.8 years and most of them were in overweight range (mean BMI: 27.0±5.8) with 818 (73%) patients having BMI more than 24.0. Patients mostly had low disease activity at presentation (DAS 28 score of 2.5±0.8). Other markers of inflammation and patient reported outcome measures (health assessment questionnaire, patient global assessment and visual analogue scale) were also in the moderate range. Seropositivity for anti-citrullinated peptides and anti-nuclear antibodies was seen in 5 (0.45%) and 43 (3.8%) patients respectively. Majority of patients were non-smokers (77%). Inflammatory arthritis on musculoskeletal ultrasonography was seen in 638 (57%). CONCLUSIONS: Undifferentiated inflammatory arthritis was more common in overweight females. Serological markers and smoking status are not common features in these patients.

Knowledge, Attitudes, and Practice Regarding COVID-19 among Patients with Musculoskeletal and Rheumatic Diseases in Nepal: A Web-Based Cross-Sectional Study.

PURPOSE: The global health crisis created by coronavirus disease in 2019, ie, COVID-19, is of serious concern to rheumatologists. The relationship of rheumatic diseases, their therapies, and COVID-19 with multiple genuine and malicious information available online can influence the knowledge and attitudes of rheumatic patients. This Google Forms study was conducted to understand the knowledge, attitudes, and practices of rheumatology patients with regard to COVID-19 in Nepal. METHODS: A web-based cross-sectional study was conducted among patients with rheumatic diseases. A modified version of a questionnaire was used after consent had been obtained. It was then translated into Nepali for comprehensibility. The final questionnaire contained a total of 29 questions: six on demographic parameters and twelve, five, and six on knowledge, attitudes and practice, respectively. Simple descriptive statistics were used to describe the positive responses in each domain. Logistic regression analysis was done to observe demographic variables associated with knowledge, attitudes, and practice. RESULTS: Among 380 participants, 63.2% were female, the majority (42.1%) aged 18-29 years, and all were literate. Most were aware of the clinical features of COVID-19 (91.6%), 71.5% had positive attitudes toward its control, some (31.5%) thought that they had a greater chance of contracting COVID-19 than others, and 18.9% believed that antirheumatic medications could increase their susceptibility to infection. A majority (>94.7%) of them practiced preventive measures. CONCLUSION: Patients with rheumatic diseases were aware of the general clinical features, routes of transmission, and general preventive measures regarding COVID-19 and did not significantly change their treatment practices.

A Qualitative Study of Patients' Beliefs and Perception on Medicinal Properties of Natural Hot Spring Bath for Musculoskeletal Problems.

Natural therapy modalities such as thermal therapy and balneotherapy are commonly being practiced for the management of chronic aches and pain all over the world. Nepal has many such natural hot water springs among which few are famous for therapeutic purposes. Thousands of people with some musculoskeletal problem visit those places in the hope of getting rid of their problems. This study aimed to understand their belief in such therapies, expectations, and satisfaction after treatment along with their knowledge of the safety of hot spring water bath. Among 126 participants interviewed, 31% had inflammatory arthritis, followed by degenerative disorders in 29.4% and soft-tissue rheumatism in 12.7%. Around three-quarters believed that hot spring water has natural healing power and thus can improve their pain. Many even believed that water in natural springs is devoid of any chemicals. So, it is a safe treatment option. Regarding the expectation of cure, they had mixed opinions. Naïve participants hoped they might find a permanent cure in thermal baths. However, repeated visitors said that the effect usually lasted for a few months and they have to visit there regularly. Almost two-thirds of people thought that such natural treatment does not have any side effects. Few stated that they had faced certain problems after the treatment. The water tested from the study site showed that it contained a higher amount of chlorine and sulfate in comparison to other hot water springs in Nepal. The minerals present in water might be a cause of temporary relief of pain. Also, outbreaks of infection from common spring baths have to be considered as such cases have been reported in the past. In conclusion, the medicinal benefits of such natural hot water springs have to be studied further and awareness regarding safety should be given to the people seeking treatment.

Translation, validation and cross-cultural adaptation of the Revised Fibromyalgia Impact Questionnaire (FIQR) in Nepali language.

OBJECTIVE: To translate, cross-culturally adapt and test the psychometric properties of the Revised Fibromyalgia Impact Questionnaire (FIQR) in Nepali language (Nepali FIQR). METHODS: The translation was performed following the methodological standards described by Beaton. Comprehensibility testing of the preliminary version was done in 40 fibromyalgia patients, and a pre-final version was prepared after making changes in the original version to maintain the equivalence with the target version. Psychometric testing was done in another group of 130 fibromyalgia patients to test for content validity and reliability. Construct validity was tested with visual analog score (VAS) for pain and Short Form (SF)-36. RESULTS: Nepali FIQR was comprehensible to 92.5% patients. The internal consistency was also acceptable with Cronbach's alpha of 0.900, 0.714 and 0.863 for function, overall and symptoms domain, respectively. Construct validity was also acceptable with a moderate correlation between Nepali FIQR and VAS and SF-36. Test-retest reliability of the total Nepali FIQR and of each item were acceptable with intraclass correlation coefficient (ICC) of >0.7 in all items except for question 1 of function domain (ICC: 0.65). CONCLUSIONS: Nepali FIQR is a comprehensible, reliable and valid tool for evaluation of the functional status of Nepalese patients with fibromyalgia and should be implemented in routine clinical care and research settings.

Efficacy of Vitamin E in Methotrexate-Induced Hepatotoxicity in Rheumatoid Arthritis: An Open-Label Case-Control Study.

OBJECTIVE: To examine the efficacy of vitamin E in methotrexate- (MTX-) induced transaminitis in patients with rheumatoid arthritis (RA). METHODS: A case-control study was conducted at a tertiary rheumatology center for 12 months. Patients with RA on MTX and deranged aminotransferases were included. Patients with previous liver diseases, baseline transaminitis before methotrexate initiation, alcohol intake, muscle diseases, under hepatotoxic drugs, and aminotransferases > 3 times the upper normal limit were excluded. The patients were divided into treatment (vitamin E 400 mg bid for 3 months) and control groups (no vitamin E) using a random number table. The dose of MTX was unaltered. Follow-up was done after 3 and 6 months. Independent t-test was done to compare means of two groups. Paired t-test was done to compare differences in mean. RESULTS: Among 230 patients, 86.5% were female with a mean BMI of 25.9 ± 4.5 kg/m2. In the treatment group, SGPT and SGOT at baseline were 73.1 ± 20.4 and 60.2 ± 24.5 IU/L, respectively; at 3-month follow-up 44.6 ± 34.2 and 38.3 ± 20.8 IU/L, respectively; and at 6-month follow-up 40.4 ± 35.7 and 34.2 ± 21.9 IU/L, respectively. In the control group, SGPT and SGOT at baseline were 63.4 ± 15.1 and 46.8 ± 13.7 IU/L, respectively, and at 3-month follow-up 55.8 ± 45.9 and 45.5 ± 30.9 IU/L, respectively. Significant decrease in the level of aminotransferases was seen in the treatment group (p value < 0.001) and not in the control group (p values 0.161 and 0.728, respectively). The change in levels of SGPT and SGOT from baseline to 3 months of follow-up was statistically significant in between two study groups (p values 0.007 and <0.001, respectively). From the control group, 29 patients were crossed over to vitamin E for the next 3 months. SGPT and SGOT decreased from 97.6 ± 44.1 to 46.1 ± 40.9 and 69.3 ± 34.9 to 29.1 ± 11.6 IU/L, respectively (p values 0.031 and 0.017, respectively). CONCLUSION: Vitamin E significantly attenuates MTX-induced transaminitis.