scholarly journals Continuation of Methotrexate Resulted in Better Clinical and Radiographic Outcomes Than Discontinuation upon Starting Etanercept in Patients with Rheumatoid Arthritis: 52-week Results from the JESMR Study

2011 ◽  
Vol 38 (8) ◽  
pp. 1585-1592 ◽  
Author(s):  
HIDETO KAMEDA ◽  
KATSUAKI KANBE ◽  
ERI SATO ◽  
YUKITAKA UEKI ◽  
KAZUYOSHI SAITO ◽  
...  

Objective.The aim of the Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan (JESMR) study is to compare the efficacy of continuation versus discontinuation of methotrexate (MTX) when starting etanercept (ETN) in patients with active rheumatoid arthritis (RA).Methods.In total, 151 patients with active RA who had been taking MTX were randomized to either ETN 25 mg twice a week with 6–8 mg/week MTX (the E+M group), or ETN alone (the E group). The primary endpoint at Week 52 was the radiographic progression assessed by van der Heijde-modified Sharp score.Results.The mean progression in total score at Week 52 was not significantly different, statistically, between the E+M group and the E group (0.8 vs 3.6, respectively; p = 0.06). However, a significant difference was observed in radiographic progression between Weeks 24 and 52 (0.3 vs 2.5; p = 0.03), and the mean progression of the erosion score was negative in the E+M group, which was significantly better than the E group at Week 52 (–0.2 vs 1.8; p = 0.02). Clinically, the cumulative probability plot of the American College of Rheumatology (ACR)-N values at Week 52 clearly demonstrated a superior response in the E+M group than in the E group. ACR20, 50, and 70 response rates at Week 52 in the E+M group (86.3%, 76.7%, and 50.7%) were significantly greater than those in the E group (63.8%; p = 0.003, 43.5%; p < 0.0001 and 29.0%; p = 0.01, respectively).Conclusion.MTX should be continued when starting ETN in patients with active RA. (ClinicalTrials.gov: NCT00688103)

2011 ◽  
Vol 38 (12) ◽  
pp. 2572-2580 ◽  
Author(s):  
PETER C. TAYLOR ◽  
CHRISTOPHER RITCHLIN ◽  
ALAN MENDELSOHN ◽  
DANIEL BAKER ◽  
LILIANNE KIM ◽  
...  

Objective.To evaluate the efficacy/safety of subcutaneous (SC) golimumab in patients with rheumatoid arthritis (RA) who previously received intravenous (IV) golimumab with or without methotrexate (MTX).Methods.Adult patients with RA (n = 643) with persistent disease despite MTX (≥ 15 mg/wk for ≥ 3 months) were randomized to IV placebo + MTX (n = 129) or IV golimumab 2–4 mg/kg (± MTX) every 12 weeks (n = 514). Patients who completed the study through Week 48 could participate in the longterm extension (LTE), comprising open-label golimumab 50 mg SC every 4 weeks (± MTX) for 24 weeks (LTE-0 to LTE-24) followed by 16 weeks of safety followup (LTE-24 to LTE-40; MTX could be adjusted).Results.At Week 48, 28% (nominal p < 0.001 vs placebo), 11%, and 8% of patients who received IV golimumab + MTX, golimumab alone, and placebo + MTX, respectively, achieved ≥ 50% improvement in the American College of Rheumatology response criteria (ACR50). Among the 505 patients who entered the LTE and were still participating, the proportion of patients treated with golimumab 50 mg SC (± MTX) achieving an ACR50 response increased to 44% at both LTE-14 and LTE-24. ACR20, ACR70, and 28-joint Disease Activity Score using C-reactive protein exhibited similar response patterns as ACR50. Infections were the most commonly reported adverse events through the end of IV golimumab dosing (37% placebo + MTX, 45% golimumab, 51% golimumab + MTX) and with SC golimumab from LTE-0 through LTE-40 (35% golimumab, 36% golimumab + MTX). Concomitant MTX use yielded lower incidences of antibodies to SC golimumab and injection-related reactions.Conclusion.Clinical improvements observed in golimumab-treated patients were sustained or improved in patients switched from IV (2–4 mg/kg ± MTX) to open-label SC (50 mg ± MTX) golimumab. Both IV and SC golimumab demonstrated acceptable safety profiles (Clinicaltrials.govNCT00361335).


2009 ◽  
Vol 36 (7) ◽  
pp. 1429-1441 ◽  
Author(s):  
PAUL EMERY ◽  
MARK C. GENOVESE ◽  
RONALD van VOLLENHOVEN ◽  
JOHN T. SHARP ◽  
KAUSHIK PATRA ◽  
...  

Objective.To determine the relationship between radiographic progression and clinical response for adalimumab plus methotrexate (MTX) versus either monotherapy in patients with early rheumatoid arthritis (RA) in the PREMIER study.Methods.Patients with early RA who received adalimumab plus MTX (n = 240), adalimumab (n = 222), or MTX (n = 216) were grouped by American College of Rheumatology (ACR) response, 28-joint Disease Activity Score (DAS28), or remission-like state [tender joint count (TJC) = 0; DAS28 < 2.6; swollen joint count = 0; ACR100] at 26 and 104 weeks. Radiographic progression was assessed by cumulative probability plots, mean changes in total Sharp score (ΔTSS), and percentages of progressors (ΔTSS > 0.5).Results.Across the spectrum of clinical outcomes, including ACR20 nonresponses and remission-like responses, therapy with adalimumab plus MTX permitted less radiographic progression at Weeks 26 and 104 than MTX monotherapy. Adalimumab monotherapy was generally intermediate. A strong, proportional relationship was observed between clinical response and radiographic efficacy only for MTX monotherapy. The monotherapies approximated the radiographic efficacy of adalimumab plus MTX only among remission-like responders, although progression was significantly greater with MTX monotherapy versus adalimumab plus MTX for patients with TJC = 0. Concurrent clinical (DAS28 < 2.6) and radiographic (ΔTSS ≤ 0.5) remission was significantly more frequent at Week 104 with adalimumab plus MTX (45%) than with adalimumab (25%) or MTX (18%) monotherapy.Conclusion.In patients with early RA, adalimumab plus MTX resulted in less radiographic progression than MTX monotherapy across the spectrum of clinical response, including ACR20 non-responses and remission-like responses.


2021 ◽  
pp. jrheum.210346
Author(s):  
Désirée van der Heijde ◽  
Cynthia E. Kartman ◽  
Li Xie ◽  
Scott Beattie ◽  
Douglas Schlichting ◽  
...  

Objective To evaluate the effect of baricitinib on inhibiting radiographic progression of structural joint damage over 5 years in patients with active rheumatoid arthritis (RA). Methods Patients completed 1 of 3 phase 3 baricitinib trials (NCT01711359, NCT01710358, NCT01721057) and entered the long-term extension RA-BEYOND (NCT01885078), in which patients received once-daily 4 mg or 2 mg baricitinib. Across these trials, patients initially receiving methotrexate (MTX) or adalimumab switched to baricitinib 4 mg at week 52. Patients initially receiving placebo switched to baricitinib 4 mg at week 24. Radiographs were scored at baseline and years 2, 3, 4, and 5. Change from baseline in van der Heijde modified Total Sharp Score (ΔmTSS) was computed. Results Overall, 2125/2573 (82.6%) randomized patients entered RA-BEYOND; 1837/2125 (86.4%) entered this analysis. From years 3 to 5, higher proportions of DMARD-naïve patients on initial baricitinib (monotherapy; +MTX) had no progression versus initial MTX (ΔmTSS≤0, year 5: 59.6% baricitinib 4 mg; 66.2% baricitinib 4 mg+MTX; 40.7% MTX). Higher proportions of patients with inadequate response (IR) to MTX on initial baricitinib or adalimumab versus placebo had no progression (ΔmTSS≤0, year 5: 54.8% baricitinib 4 mg; 55.0% adalimumab; 50.3% placebo). Higher proportions of patients with conventional synthetic (cs)DMARD-IR on initial baricitinib 4 mg had less progression versus initial placebo or baricitinib 2 mg (ΔmTSS≤0, year 5: 66.7% baricitinib 4 mg; 58.2% baricitinib 2 mg; 60.0% placebo). Conclusion Oral baricitinib maintained lower levels of radiographic progression than initial csDMARD or placebo through 5 years in patients with active RA.


2019 ◽  
Vol 47 (6) ◽  
pp. 796-808 ◽  
Author(s):  
Walter P. Maksymowych ◽  
Oliver FitzGerald ◽  
Mikkel Østergaard ◽  
Joanne Homik ◽  
Désirée van der Heijde ◽  
...  

Objective.The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.Methods.Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.Results.A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7% rheumatoid factor–positive or anticitrullinated protein antibody–positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2% and 59.9%, respectively.Conclusion.The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956)


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kuan-Kai Tung ◽  
Yun-Che Wu ◽  
Kun-Hui Chen ◽  
Chien-Chou Pan ◽  
Wen-Xian Lu ◽  
...  

Abstract Background Clinical outcomes amongst Rheumatoid Arthritis (RA) patients have shown satisfactory results being reported after lumbar surgery. The increased adoption of the interbody fusion technique has been due to a high fusion rate and less invasive procedures. However, the radiographic outcome for RA patients after receiving interbody fusion has scarcely been addressed in the available literature. Methods Patients receiving interbody fusion including ALIF, OLIF, and TLIF were examined for implant cage motion and fusion status at two-year follow-up. Parameters for the index correction level including ADH, PDH, WI, SL, FW, and FH were measured and compared at pre-OP, post-OP, and two-year follow-up. Results We enrolled 64 RA patients at 104 levels (mean 64.0 years old, 85.9% female) received lumbar interbody fusion. There were substantial improvement in ADH, PDH, WI, SL, FW, and FH after surgery, with both ADH and PDH having significantly dropped at two-year follow up. The OLIF group suffered from a higher subsidence rate with no significant difference in fusion rate when compared to TLIF. The fusion rate and subsidence rate for all RA patients was 90.4 and 28.8%, respectively. Conclusions We revealed the radiographic outcomes of lumbar interbody fusions towards symptomatic lumbar disease in RA patients with good fusion outcome despite the relative high subsidence rate amongst the OLIF group. Those responsible for intra-operative endplate management should be more cautious to avoid post-OP cage subsidence.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 497.2-497
Author(s):  
J. Arroyo Palomo ◽  
M. Arce Benavente ◽  
C. Pijoan Moratalla ◽  
B. A. Blanco Cáceres ◽  
A. Rodriguez

Background:Musculoeskeletal ultrasound (MSUS) is frequently used in several rheumatology units to detect subclinical inflammation in patients with joint symptoms suspected for progression to inflammatory arthritis (IA). Synovitis grade I (EULAR-OMERACT combined score) is known to be a casual finding in healthy individuals, but studies headed to unravel its possible role on rheumatic diseases are sparse.Objectives:To investigate the correlation between synovitis grade I, and the diagnosis of IA made after a year follow-up period since MSUS findings, in patients of an MSUS-specialized unit of a Rheumatology Department.Methods:We conducted a descriptive, retrospective and unicentric study. 30 patients were selected from the MSUS-specialized unit of our Rheumatology Department from July-18 to January-19. Patients presenting synovitis grade 0 (exclusively), 2 and/or 3 on combined score were excluded. Data collection at baseline included age, sex, immunological profile and previous physical examination to the MSUS findings, as well as the diagnosis made by the rheumatologist in 1-year visit follow-up: dividing the patient sample into two groups: those who were diagnosed with IA and those not. Non-parametric statistical tests for comparing means were used.Results:The mean age was 51,6 years and 70% were females. 6 (20%) patients were diagnosed with inflammatory arthritis after a year follow-up: 2 (4,8%) psoriatic arthritis, 1 (3,3%) undifferentiated arthritis, 1 (3,3%) rheumatoid arthritis, 1 (3,3%) Sjögren’s syndrome. Non-inflammatory arthropathies were also found 24 (80%), of which, 12 (40%) were non-specific arthralgias and 8 (19%) osteoarthritis.In the group of patients who did not developed an IA the mean C-reactive protein (CPR) value was 3,12 mg/L and erythrocyte sedimentation rate (ESR) was 8,2 mm; all of them were rheumatoid factor (RF) positive and ACPA-negative except one patient. 5 (31,3%) patients presented low antinuclear antibodies (ANAs) levels. In those who HLA B-27 and Cw6 were tested (4,25%); both were negative except for one that was HLA B-27 positive. The median number of swollen and painful joint count was 0, and the mean of joints with MSUS involvement was 3,5; the mean involved metacarpophalangeal (MCP) joints was 1,83; proximal interphalangeal (PIP) joints was 1,48 and distal interphalangeal (DIP) joints 0,21.Among the group of patients that developed an IA the mean of CPR and ESR was 9,27 mg/L and 14,17 mm respectively; 2 (33%) patients were RF- positive, and 1 ACPA-positive. ANAs were positive in 3 cases (50%). The median of swollen joint count was 2 and for painful joint count was 0, the median of joints with MSUS involvement was 4,5. The mean of MSUS involvement was for MCP, PIP and DIP joints: 1,67, 2 and 0. Comparing the means of CPR values in the two groups with Student’s t-test we obtained a statistically significant difference (p=0,023). No other significant differences were found.Conclusion:Despite the limitations and possible statistical bias, the presence of MSUS-defined synovitis grade I and elevated CRP levels could be related to further diagnoses of inflammatory arthropathy. Besides, the absence of synovitis in DIP joints might have a diagnostic role. Normal physical exploration and normal levels of CRP might suggest low MSUS value. However, further research is needed to clarify the role of MSUS-defined synovitis grade I.References:[1]D’Agostino MA et al. Scoring ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 1: definition and development of a standardized, consensus-based scoring system. RMD Open. 2017;3(1):e000428.[2]Van den Berg R et al. What is the value of musculoskeletal ultrasound in patients presenting with arthralgia to predict inflammatory arthritis development? A systematic literature review. Arthritis Research & Therapy (2018) 20:228.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 526.1-526
Author(s):  
L. Nacef ◽  
H. Riahi ◽  
Y. Mabrouk ◽  
H. Ferjani ◽  
K. Maatallah ◽  
...  

Background:Hypertension, diabetes, and dyslipidemia are traditional risk factors of cardiac events. Carotid ultrasonography is an available way to detect subclinical atherosclerosis.Objectives:This study aimed to compare the intima-media thickness in RA patients based on their personal cardiovascular (CV) history of hypertension (hypertension), diabetes, and dyslipidemia.Methods:The present study is a prospective study conducted on Tunisian RA patients in the rheumatology department of Mohamed Kassab University Hospital (March and December 2020). The characteristics of the patients and those of the disease were collected.The high-resolution B-mode carotid US measured the IMT, according to American Society of Echocardiography guidelines. The carotid bulb below its bifurcation and the internal and external carotid arteries were evaluated bilaterally with grayscale, spectral, and color Doppler ultrasonography using proprietary software for carotid artery measurements. IMT was measured using the two inner layers of the common carotid artery, and an increased IMT was defined as ≥0.9 mm. A Framingham score was calculated to predict the cardiovascular risk at 10-year.Results:Forty-seven patients were collected, 78.7% of whom were women. The mean age was 52.5 ±11.06 [32-76]. The rheumatoid factor (RF) was positive in 57.8% of cases, and anti-citrullinated peptide antibodies (ACPA) were positive in 62.2% of cases. RA was erosive in 81.6% of cases. Hypertension (hypertension) was present in 14.9% of patients, diabetes in 12.8% of patients, and dyslipidemia in 12.8% of patients. Nine patients were active smokers. The mean IMT in the left common carotid (LCC) was 0.069 ±0.015, in the left internal carotid (LIC) was 0.069 ±0.015, in the left external carotid (LEC) was 0.060 ±0.023. The mean IMT was 0.068 ±0.01 in the right common carotid (RCC), 0.062 ±0.02 in the right internal carotid (RIC), and 0.060 ±0.016 in the right external carotid (REC). The IMT was significantly higher in the left common carotid (LCC) in patients with hypertension (p=0.025). There was no significant difference in the other ultrasound sites (LIC, LEC, RCC, RIC, and REC) according to the presence or absence of hypertension. The IMT was also significantly increased in patients with diabetes at LCC (p=0.017) and RIC (p=0.025). There was no significant difference in the IMT at different ultrasound sites between patients with and without dyslipidemia.Conclusion:Hypertension was significantly associated with the increase in IMT at the LCC level in RA patients. Diabetes had an impact on IMT in LCC and RIC. However, dyslipidemia did not affect the IMT at the different ultrasound sites.References:[1]S. Gunter and al. Arterial wave reflection and subclinical atherosclerosis in rheumatoid arthritis. Clinical and Experimental Rheumatology 2018; 36: Clinical E.xperimental.[2]Aslan and al. Assessment of local carotid stiffness in seronegative and seropositive rheumatoid arthritis. SCANDINAVIAN CARDIOVASCULAR JOURNAL, 2017.[3]Martin I. Wah-Suarez and al, Carotid ultrasound findings in rheumatoid arthritis and control subjects: A case-control study. Int J Rheum Dis. 2018;1–7.[4]Gobbic C and al. Marcadores subclínicos de aterosclerosis y factores de riesgo cardiovascular en artritis temprana. Subclinical markers of atherosclerosis and cardiovascular risk factors in early arthritis marcadores subclínicos de aterosclerose e fatores de risco cardiovascular na artrite precoce.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1119.1-1119
Author(s):  
L. Nacef ◽  
Y. Besbes ◽  
Y. Mabrouk ◽  
H. Ferjani ◽  
K. Maatallah ◽  
...  

Background:The lipid paradox is termed the decreased cholesterol level in rheumatoid arthritis (RA). Nevertheless, the apolipoprotein levels are usually higher than a healthy person and are predictors of cardiovascular events.Objectives:We aimed to describe lipid abnormalities in RA patients and to look for predictor factors of these changes.Methods:The prospective study was carried out on patients with RA who met the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. These patients were followed in the rheumatology department of the Kassab Institute.We collected the socio-demographic data, biological and immunological parameters.The lipid assessment included: a measurement of total cholesterol (TC), HDL, LDL, and triglycerides (TG). Lipoproteins APOA1 and APOB were measured. All data were collected after patient consent.Results:Of the 47 patients recruited, 78.7% were female. The mean age was 52.5 ±11.06 [32-76]. The average RA progressed from 86.25 ±63 months [5-288] and was erosive in 81.6% of cases. The rheumatoid factor (RF) was positive in 57.8% of patients, and citrullinated antipeptide antibodies (ACPA) were present in 62.2%. Eight patients had a previous CV history.Mean TC was 4.42 ±1.3 [1.2-7.58], mean HDL was 1.38 ±0.73 [0.18-4.10], mean LDL was 2.55 ±1.16 [0.24-5.54]. The mean TG value was 1.28 ±0.6 [0.24-5.54]. TC elevation was found in 9.1% of cases, HDL in 21.3% of cases, LDL in 5.5% of cases, and TG in 16.4% of cases. Mean APOB/APOA1 ratio was 0.67 ±0.18 [0,46-1,11]. LDL elevation was associated to a high DAS28 (p=0.06, r=0.512). APOA1 was associated to a low DAS28 (p=0.04, r=-0.642).The mean value of APO A1 was 1.36 ±0.21 [0.84-1.81], that of APOB was 0.90 ±0.22 [0.58-1.40]. APOA1 values were lower in patients with high-level LDL (p=0.767). The APOB value was associated with lipid disturbance without significant correlation (p=0.291).Conclusion:Lipid test abnormalities can be found in RA patients outside of any known CV risk factors. APOA1 seems to have a protective effect. Screening and treatment of these abnormalities can prevent CV risk.References:[1]Miguel Bernardes and al. Coronary artery calcium score in female rheumatoid arthritis patients: Associations with apolipoproteins and disease biomarkers. Int J Rheum Dis. 2019;00:1–16.[2]Anna So dergren and al. Biomarkers associated with cardiovascular disease in patients with early rheumatoid arthritis. PLOS ONE. August 5, 2019.Disclosure of Interests:None declared


Cartilage ◽  
2021 ◽  
pp. 194760352110219
Author(s):  
Danielle H. Markus ◽  
Anna M. Blaeser ◽  
Eoghan T. Hurley ◽  
Brian J. Mannino ◽  
Kirk A. Campbell ◽  
...  

Objective The purpose of the current study is to evaluate the clinical and radiographic outcomes at early to midterm follow-up between fresh precut cores versus hemi-condylar osteochondral allograft (OCAs) in the treatment of symptomatic osteochondral lesions. Design A retrospective review of patients who underwent an OCA was performed. Patient matching between those with OCA harvested from an allograft condyle/patella or a fresh precut allograft core was performed to generate 2 comparable groups. The cartilage at the graft site was assessed with use of a modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system and patient-reported outcomes were collected. Results Overall, 52 total patients who underwent OCA with either fresh precut OCA cores ( n = 26) and hemi-condylar OCA ( n = 26) were pair matched at a mean follow-up of 34.0 months (range 12 months to 99 months). The mean ages were 31.5 ± 10.7 for fresh precut cores and 30.9 ± 9.8 for hemi-condylar ( P = 0.673). Males accounted for 36.4% of the overall cohort, and the mean lesion size for fresh precut OCA core was 19.6 mm2 compared to 21.2 mm2 for whole condyle ( P = 0.178). There was no significant difference in patient-reported outcomes including Visual Analogue Scale, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement, and Tegner ( P > 0.5 for each), or in MOCART score (69.2 vs. 68.3, P = 0.93). Conclusions This study found that there was no difference in patient-reported clinical outcomes or MOCART scores following OCA implantation using fresh precut OCA cores or size matched condylar grafts at early to midterm follow-up.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 499.2-500
Author(s):  
A. De Diego Sola ◽  
M. Vaamonde Lorenzo ◽  
A. Castiella Eguzkiza ◽  
M. J. Sánchez Iturri ◽  
N. Alcorta Lorenzo ◽  
...  

Background:Despite therapeutic advances in recent years, methotrexate (MTX) remains the gold standard for the treatment of rheumatoid arthritis (RA). Among the side effects that have been blamed on it are liver fibrosis (LF) and cirrhosis, although late studies have failed to show such a relation1,2. The only validated test in the diagnosis of LF is biopsy. Given the relevance of MTX in the treatment of RA, it is important to evaluate non-invasive diagnostic options for LF such as transitional elastography (FibroScan, FS).Objectives:To evaluate the percentage of LF in RA patients treated with MTX. Secondly, to assess the correlation between altered liver function, RA activity, and LF. To determine whether dose and/or duration of treatment with MTX may affect the development of LF in such patients.Methods:We did a prospective study between February 2019 and January 2020. Patients affected of RA treated with MTX were included. Patients with basal liver disease (hepatitis B, hepatitis C and steatohepatitis), alcohol consumption, type I diabetes mellitus, chronic renal failure, heart failure, obesity and concomitant treatment with leflunomide or antiretrovirals were excluded. Demographic, clinical, analytical and therapeutic variables were collected. Liver fibrosis was assessed by FS in kilopascals (kpa) and using the APRI score. RA activity was assessed by DAS28 score. Continuous variables are described with mean and standard deviation (SD), and qualitative variables are shown with absolute value and percentage. Spearman’s and Mann-Whitney’s U tests were used for the bivariate analysis.Results:Fifty patients were included (Table 1 and 2). Of these, 38 were women (76%) with mean age of 61.8 years (SD 11.7) and mean RA evolution time of 13.7 years (SD 8.2). The mean DAS28 at the visit was 2.39 (SD 1.1). The FS showed an average of 4.8 kpa (SD 2). The mean duration of treatment with MTX was 85.8 months (SD 93.3) and that of AD-MTX was 5414.6mg (SD 5011). Patients were divided into those with DA-MTX greater than 4000mg (21, 42%) and less than 4000mg (29, 58%) and no significant differences were found in terms of LF in FS (p 0.637) or APRI scale (p 0.806). No significant differences were found in terms of treatment duration either. Six patients (12%) had elevated aspartate aminotransferase (AST) and 9 (18%) had elevated alanine aminotransferase (ALT). No significant difference was found in FS values in relation to ALT, but it was with elevated AST (p 0.021). Similarly, differences were found in APRI based on AST (p 0.045). Metabolic syndrome was collected in 4 patients (8%) without significant differences with FS or APRI values. There were no significant differences in LF depending on gamma-glutamyl transpeptidase (GGT) values.Conclusion:FS and APRI score are useful for the determination of LF in RA patients treated with MTX. There is no evidence of a relationship between AD-MTX and LF by FS or APRI. AST values may be related to the presence of fibrosis as determined by FS or APRI. and the presence of the metabolic syndrome are not.References:[1]G.L. Erre, et al. Methotrexate therapy is not associated with increased liver stiffness and significant liver fibrosis in rheumatoid arthritis patients: A cross-sectional controlled study with real-time two-dimensional shear wave elastography. European Journal of Internal Medicine 69 (2019) 57–63. Internet.[2]R. Conway et al. Risk of liver injury among methotrexate users: a meta-analysis of randomised controlled trials. Semin Arthritis Rheum 2015 Oct;45(2):156–62. Internet.Disclosure of Interests:None declared


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