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ID PMID Title PublicationDate abstract
26097790 The pharmacokinetic effect of coadministration of apremilast and methotrexate in individua 2014 Nov Apremilast is a novel agent for the treatment of inflammatory based autoimmune disorders. The objective of this study was to assess the pharmacokinetic effects of co administration of apremilast and methotrexate on both agents. This was an open-label, multi-center, 3-treatment period, sequential study conducted in otherwise healthy subjects with psoriatic arthritis or rheumatoid arthritis who were receiving a stable oral dose of methotrexate between 7.5 to 20 mg once weekly. Subjects received their dose of methotrexate on Days 1 and 8 of the study in addition to Apremilast 30 mg oral every 12 hours on Days 3-8. Pharmacokinectic profiles of methotrexate and 7-OH methotrexate were characterized after methotrexate alone (Day 1) and after co-administration of methotrexate and Apremilast (on Day 8). The pharmacokinetic profile of Apremilast was characterized after Apremilast alone (on Day 7) and after co-administration of methotrexate and Apremilast (on Day 8). The 90% confidence interval of the ratio of the geometric means for the C(max) and AUC parameters for methotrexate, 7-OH methotrexate, and Apremilast alone and after co-adminstration are all within the FDA acceptance range for equivalency (80-125%). This study showed that methotrexate and apremilast can be co-administered without any effect on the pharmacokinetic exposure of either agent.
25546784 7th International Immunoglobulin Conference: Immunomodulation. 2014 Dec Immunomodulation uses synthetic, natural and recombinant preparations to modify the immune response to a desired level, typically to treat specific autoimmune diseases, as will be discussed in this section. Rheumatoid arthritis (RA) is a common systemic autoimmune disease, affecting 1% of the population worldwide. Currently, a first-line disease-modifying therapy for RA is methotrexate; however, more than 40 monoclonal antibodies are in use or under investigation for the treatment of RA. This panoply of biological disease-modifying agents means that clinicians can make use of drugs with different mechanisms of action should one type become ineffective. In autoimmune pemphigus conditions, identification of pathogenic autoantibodies against intercellular cadherin desmoglein 1 and/or 3 antigens is one of the criteria for appropriate diagnosis. In pemphigoid conditions, autoantibodies are directed against bullous pemphigoid antigens BP230 and BP180, and in both types of immunobullous disease intravenous immunoglobulin (IVIg), as adjuvant therapy in combination with a cytotoxic drug, is effective in reducing autoantibody levels, disease severity and background steroid use. Further studies are required to establish the role of monoclonal antibodies in the treatment of autoimmune bullous disease. IVIg may also be effective in another at-risk population with autoimmune disease, namely secondary recurrent miscarriage (RM). However, the mechanism of action of IVIg in secondary RM is largely unknown, although levels of natural killer cell biomarkers, particularly CD56(+) , have been shown to decline after IVIg treatment. Data from meta-analyses of heterogeneous placebo-controlled trials indicate that IVIg may be effective in secondary RM, but most trials to date have used immunomodulatory doses lower than those considered to be efficient in autoimmune disease. The results of a recently completed study may help to address this question.
23233115 Inclusion body myositis associated with Sjögren's syndrome. 2013 Dec Inclusion body myositis (IBM) belongs to the group of idiopathic inflammatory myopathies. It is a poorly understood disease, which affects skeletal muscles. IBM usually occurs as an isolated condition, but in some cases, it may be associated with another autoimmune disorder, Sjögren's syndrome. We report a case of a 47-year-old woman with headaches, symptoms of trigeminal neuralgia, progressive weakness in muscles of the upper and lower extremities and symptoms of dry eyes and mouth. On admission, creatine kinase level was increased to 6,956 IU/mL and lactate dehydrogenase (LDH) to 1,011 U/L in the serum. The increase in inflammatory factor (CRP, ESR) levels was not found. The diagnosis of inclusion body myositis associated with Sjögren's syndrome was established on the basis of clinical picture and diagnostic tests. In this therapy, methotrexate and methylprednisolone were administered. The considerable improved muscle strength in the upper and lower extremities, improved speech and swallowing, disappearance of headache and reduction in CPK and LDH levels were found 8 months after establishing the diagnosis. Treatment with methotrexate and methylprednisolone improved the clinical symptoms and quality of life of this patient and may offer a therapeutic option for some patients with IBM and concomitant Sjögren's syndrome.
23623942 Torilin ameliorates type II collagen-induced arthritis in mouse model of rheumatoid arthri 2013 Jun Advancements in rheumatoid-arthritis-(RA) therapies have shown considerable progresses in the comprehension of disease. However, the development of new potential agents with relative safety and efficacy continues and natural compounds have been considered as alternatives to identify new entities. Since previous in-vivo data and our in-vitro findings showed that torilin has a strong anti-inflammatory property, we further investigated its effect against collagen-induced-arthritis-(CIA) in mice. CIA-induced DBA/1J mice were treated with torilin or methotrexate (MTX) for 5-weeks. Arthritis severity was evaluated by arthritic score and joint histopathology. Draining lymph node (dLN), joint and peripheral-blood mononuclear-cell (PBMC) counts, and activation/localization of T-/B-lymphocytes, dendritic cells (DCs) and neutrophils were examined by FACS analysis. Serum anti-type-II-collagen-(CII) antibody levels and cultured-splenocyte and serum cytokines were also evaluated. Torilin markedly reduced CIA-induced arthritic score, histopathology and leukocyte counts. Besides, torilin suppressed CIA-activated T-cells including CD3+, CD3+/CD69+, CD8+, CD4+ and CD4+/CD25+ in dLNs or joints. It also modified CD19+ or CD20+/CD23+ (B-cells), MHCII+/CD11c+ (DCs) and Gr-1+/CD11b+ (neutrophil) subpopulations. It further depressed total anti-CII-IgG, anti-CII-IgG1 and anti-CII-IgG2a antibody productions. Moreover, while IFN-γ and IL-10 were not affected, torilin suppressed CIA-induced serum TNF-α, IL-1β and IL-6 levels. Interestingly, torilin also blocked IFN-γ, IL-17 and IL-6 cytokines while it did not affect IL-10 but enhanced IL-4 in splenocytes. These results show that torilin attenuated arthritis severity, modified leukocyte activations in dLNs or joints, and restored serum and splenocyte cytokine imbalances. Torilin may have immunomodulatory and anti-inflammatory properties with the capacity to ameliorate the inflammatory response in CIA-mice.
24455421 Low serum levels of myeloid progenitor inhibitory factor-1 predict good response to methot 2013 Dec 24 Background. Although the benchmark in the treatment of rheumatoid arthritis remains methotrexate, only 70% of patients respond. Thus, there is a need for predictive biomarkers. This study planned to evaluate serum levels of myeloid progenitor inhibitory factor-1 (MPIF-1) and monocyte chemoattractant protein 2 (MCP-2)-as biomarkers. Methods. Patients with rheumatoid arthritis (RA) having high disease activity (DAS28-3v ≥ 5.1) were treated with oral methotrexate (MTX) for 12 weeks. Disease activity was measured by DAS28-3v (Modified Disease Activity Score 3 variables). Serum samples were stored at baseline and 12 weeks. Results. This study included 46 patients (F : M = 35 : 11) having mean (±SD) age of 42.6 ± 11.3 yrs, disease duration of 4.7 ± 4.5 yrs, and DAS28-3v of 6.1 ± 0.8. Serum MPIF1 was elevated in patients compared to controls (1636.7 ± 1009.7, 441.2 ± 173.8 pg/mL, P < 0.001), but there was no difference in MCP2 levels (31.4 ± 11.9, 33.8 ± 24.0 pg/mL). Baseline MPIF-1 level was lower in good responders (ΔDAS28-3v ≥ 1.2, N = 9) compared to poor responders (ΔDAS28-3v < 0.6, N = 27) (1171.0 ± 670.8, 1816.7 ± 1154.1 pg/mL, P = 0.05). On ROC analysis, baseline MPIF1 performed reasonably to predict good response; that is, ΔDAS28-3v ≥ 1.2 (AUC 0.68, 95% CI 0.50-0.87). Conclusions. Lower baseline MPIF1 level predicted a good response to methotrexate at 12 weeks.
24219040 Methotrexate in psoriatic arthritis. 2013 Psoriatic arthritis (PsA) is a form of inflammatory arthritis that occurs in patients with psoriasis and is distinct from rheumatoid arthritis (RA). Methotrexate (MTX) is one of the most commonly used drugs for the treatment of PsA, yet there is scant controlled trial data to document its efficacy. Controlled trials have not demonstrated significant separation from placebo, but the studies have significant limitations which inhibit our ability to draw firm conclusions about the efficacy of MTX. A number of observational studies have described benefit for joint and skin disease. As yet unstudied, are the effects on enthesitis, dactylitis, and spondylitis of PsA. Psoriasis studies have shown modest benefit for psoriatic skin lesions. It is not yet known if MTX contributes an additive or synergistic benefit when used in combination with TNF inhibitors in PsA. The potential value of low dose MTX to suppress antibody formation against biologic therapies should be considered in a patient fail- ing benefit from such therapy. Although adverse effects are similar to those seen in RA treatment with MTX, awareness of the tendency for PsA and psoriasis patients to be obese and have non-alcoholic steatohepatosis, which may amplify transaminitis potential, should be borne in mind.
25130128 Grade 3 lymphomatoid granulomatosis in a patient receiving methotrexate therapy for rheuma 2014 Lymphomatoid granulomatosis (LyG) is a rare, B-cell derived, lymphoproliferative disorder that often presents as pulmonary nodular lesions with a histopathology of lymphatic invasion of the vascular wall. The development of LyG may be associated with reactivation of the Epstein-Barr virus under an immunosuppressive state. We herein report a case of Grade 3 LyG that developed during methotrexate therapy for rheumatoid arthritis and regressed following the withdrawal of the drug.
25610674 Primary hepatic lymphoma in a patient with rheumatoid arthritis treated with methotrexate. 2014 Primary hepatic lymphoma (PHL) has rarely been reported in patients with immunosuppression. We herein describe a case of Epstein-Barr virus- (EBV-) positive PHL in a 67-year-old Japanese woman receiving methotrexate (MTX) treatment for rheumatoid arthritis (RA). The patient, who had been receiving MTX therapy for more than 6 years, presented with low-grade fever and abdominal pain. Initial laboratory tests showed mildly elevated liver enzymes with normal levels of alpha-fetoprotein and carcinoembryonic antigen, and computed tomography scans revealed multiple hepatic tumors with no lymph-node swelling. Examination of liver specimens obtained via ultrasonography-guided needle biopsy indicated EBV-positive diffuse large B cell lymphoma; therefore, she was diagnosed with PHL. MTX was discontinued, and she was carefully monitored thereafter owing to the prolonged history of MTX administration for RA. Rapid progression of PHL was observed; therefore 10 days after the PHL diagnosis, she received 6 cycles of R-THP-COP (rituximab, cyclophosphamide, pirarubicin, vincristine, and prednisolone) therapy and achieved complete remission for more than 1 year. Although MTX-associated lymphoproliferative disorders often show remission after withdrawal of MTX, early diagnosis and treatment are essential for PHL in patients with RA treated with MTX, because of the aggressive nature of the disease.
24588123 Adalimumab in the treatment of rheumatoid arthritis. 2014 Mar 4 Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory disease that causes increased morbidity and mortality. The treatment of the disease has considerably advanced with the addition of biological agents targeting pro-inflammatory cytokines such as tumor necrosis factor (TNF). Adalimumab (ADA) is one of the currently available five TNF inhibitors for clinical use in RA. It is a fully humanized monoclonal antibody which may be prescribed as monotherapy or in combination with methotrexate or other disease-modifying antirheumatic drugs. Areas covered: This review summarizes the recent available data on efficacy and safety of ADA in patients with early and established RA as well as improvement of quality of life and finally we provide data on biologic drug comparison. Expert opinion: ADA has been evaluated in various randomized placebo-controlled trials in RA, prospective observational studies as well as open-label extensions of the original double-blind trials providing experience and data about the long-term efficacy and safety of the drug. Effectiveness of the drug is sustained, while in most cases RA patients treated with ADA experienced a slower radiographic progression and consequently less disability and improved health-related quality of life outcomes. Clinical trials demonstrated no new safety signals and a safety profile consistent with that of the anti-TNF class.
23737767 Interactions among Low Dose of Methotrexate and Drugs Used in the Treatment of Rheumatoid 2013 Methotrexate (MTX) is a nonbiological disease-modifying antirheumatic drug that has shown both a good control of clinical disease and a good safety. Usually drug-drug interactions (DDIs) represent the most limiting factor during the clinical management of any disease, in particular when several drugs are coadministered to treat the same disease. In this paper, we report the interactions among MTX and the other drugs commonly used in the management of rheumatoid arthritis. Using Medline, PubMed, Embase, Cochrane libraries, and Reference lists, we searched for the articles published until June 30, 2012, and we reported the most common DDIs between MTX and antirheumatic drugs. In particular, clinically relevant DDIs have been described during the treatment with MTX and NSAIDs, for example, diclofenac, indomethacin, or COX-2 inhibitors, and between MTX and prednisone or immunosuppressant drugs (e.g., leflunomide and cyclosporine). Finally, an increase in the risk of infections has been recorded during the combination treatment with MTX plus antitumor necrosis factor- α agents. In conclusion, during the treatment with MTX, DDIs play an important role in both the development of ADRs and therapeutic failure.
24707285 Steroids Decrease Prevalence of Positive Tuberculin Skin Test in Rheumatoid Arthritis: Imp 2014 Tuberculin skin test has been used as an indicator of latent tuberculosis in patients with Rheumatoid Arthritis (RA) before administration of biologicals. Effect of Disease modifying antirheumatic drugs (DMARDs) and steroids on the result of tuberculin skin test (TST) may have important implications in interpretation of results of this test. Objectives. To find the prevalence of positive TST in rheumatoid patients and the effect of standard treatment on the results of TST. Method. In this cross-sectional study two hundred and fifty patients of RA above 18 years of age, classified using 1987 ACR criteria for RA, were enrolled from rheumatology outdoor. Demographics, disease activity, disease duration, and therapy were recorded. All patients underwent TST. Results. Fifty-one (20.4%) patients were found to be tuberculin positive. Tuberculin positivity was not affected by MTX intake but it was significantly low in patients with recent steroid intake as compared to patients who had not taken steroids in last 3 months (3% versus 25%, P = 0.002). Conclusion. Prevalence of tuberculin positivity in patients with RA was found to be low. Results were not affected by methotrexate; however tuberculin skin test results in patients with recent use of steroids are likely to be negative.
27708892 Presentation of three cases followed up with a diagnosis of Felty syndrome. 2014 Sep An effective treatment strategy for Felty syndrome (FS) has not been developed so far. In this article, three cases with FS, who responded to different treatment modalities, have been presented. Case 1 was a 52-year-old male patient who initially received methotrexate, and then, he was switched to granulocyte colony-stimulating factor (G-CSF) and cyclosporine treatment when his neutropenia was further deteriorated. The patient needed monthly doses of G-CSF for nearly 6 months, and his steroid dose was increased. Afterwards, his neutropenia improved with cyclosporine, methotrexate, and hydroxychloroquine combination treatment. Case 2 was a 78-year-old female patient who was started on leflunomide, hydroxychloroquine, and 60 mg methylprednisolone. Case 3 was a 69-year-old female patient who was first treated with 32 mg methylprednisolone, G-CSF, and then with cyclosporine. Neutropenia of both patients improved, and their health status normalized at 2 months. Different treatment strategies have been tried for the management of FS; disease-modifying anti-rheumatic drugs have been used successfully alone or in combination with G-CSF. As seen in the last case, it should be kept in mind that patients can present predominantly with symptoms of infection or hematologic disorders.
24129139 Can traditional disease-modifying anti-rheumatic drugs be withdrawn or tapered in psoriati 2013 Jul Psoriatic arthritis (PsA) is a complex, multisystem disease with musculoskeletal and skin manifestations frequently associated with features of the metabolic syndrome. For many years, treatment strategies were largely borrowed from the rheumatoid arthritis literature, with clinical trials of traditional DMARDs in PsA often inadequate and using limited outcome measures. Nonetheless, DMARDs - in particular, methotrexate - remain the treatment of first choice for most rheumatologists treating this disease, especially for those with prominent polyarticular involvement. While there is no agreed definition of remission in PsA, a number of longitudinal studies suggests that remission can be achieved in approximately 25% of patients treated with traditional DMARDs, with drug-free remission possible in <10%. There are many unanswered questions, and this review concludes by highlighting a research agenda which aims to address some of the most critical questions for physicians and patients alike faced with deciding if treatment should be withdrawn or continued when disease remission is achieved.
23751410 Reactive macrophage activation syndrome possibly triggered by canakinumab in a patient wit 2013 Dec Macrophage activation syndrome (MAS) is a rare and serious complication of adult-onset Still's disease. We describe a case in a 49-year-old woman with Still's disease refractory to glucocorticoids, methotrexate, and infliximab. Anakinra provided satisfactory disease control for 1 year, after which escape phenomenon occurred. After four tocilizumab injections, cutaneous melanoma developed. The persistent systemic manifestations prompted treatment with two canakinumab injections. Ten days later, she had a spiking fever, dyspnea, low back pain, abdominal pain, odynophagia, and hepatomegaly. Laboratory tests showed liver cytolysis (180 IU/L; N: 10-35), acute renal failure (creatinine, 407 μmol/L; N:50-100), thrombocytopenia (60 G/L; N: 150-400), leukocytosis (12,200/mm(3); N: 4000-10,000), hypertriglyceridemia (5070 mmol/L; N: 0.4-1.6), lactate dehydrogenase elevation (4824 IU/L; N: 135-250), and hyperferritinemia (97 761 μg/L; N:15-150). Examination of a bone marrow biopsy showed phagocytosis. Tests were negative for viruses and other infectious agents. Glucocorticoid therapy (1.5 mg/Kg/d) and intravenous polyvalent immunoglobulins (0.5 g/Kg/d) were given. Her condition improved despite the many factors of adverse prognostic significance (thrombocytopenia, absence of lymphadenopathy, and glucocorticoid therapy at diagnosis). This is the first reported case of MAS after canakinumab therapy in a patient with adult-onset Still's disease.
24381766 Disease Activity and Bone Mineral Density of MCP Joints in Patients with Rheumatoid and Ps 2013 Background. Bone damage in rheumatoid arthritis (RA) and in psoriatic arthritis (PsA) includes an accelerated bone mineral density (BMD) reduction. The objective was to evaluate BMD variations of the metacarpophalangeal joints (MCPs) in patients starting treatment with methotrexate (MTX) or etanercept. Methods. Patients affected by RA or PsA with hand joints involvement and with moderate or high disease activity, were enrolled in this study. All patients underwent clinical examination, laboratory exams, and a DXA scan of the most affected hand, as assessed with an ultrasound examination at the baseline, at the time of enrolment and after 1, 3, 6, and 12 months. Patients non-responders to MTX received combination therapy, while patients with no previous treatment initiated MTX. Results. 22 patients were enrolled. In both RA and PsA groups, BMD increased independently of the treatment. However, in the patients affected by RA, a slight BMD decrease was observed at the last checkup. Globally, the BMD variations of the MCPs were strongly correlated with the disease activity. At the reduction of DAS28, the scores corresponded an increase of BMD. Conclusions. MCPs BMD is inversely correlated to disease activity. BMD increase seems to be correlated with the response to treatment and not with the drug itself.
24044622 Nijmegen breakage syndrome and chronic polyarthritis. 2013 Sep 17 We report on pediatric patient with Nijmegen breakage syndrome (NBS), a rare DNA repair disorder characterized by microcephaly, immunodeficiency and predisposition to malignant lymphomas, who developed juvenile idiopathic arthritis (JIA)-like polyarthritis. In patients with primary immunodeficiencies (PID), septic arthritis due to pyogenic bacteria or mycoplasmal arthritis are the most common osteoarticular manifestations. In certain PID, chronic, non-infectious arthritis resembling rheumatoid arthritis may occur. In our patient microbiologic cultures of synovial fluid including Mycoplasma spp. were negative. At first, because of suspected mycoplasmal arthritis we used macrolides and doxycycline combined with hydroxychloroquine but without therapeutic response. However, the use of rituximab led to remission of her polyarthritis lasting for 9 months. Autoimmune features were rarely reported in NBS. An occurrence of JIA-like, chronic polyarthritis in NBS, a DNA repair disorder characterized by decreased tolerance of immunosuppressive drugs such as methotrexate and a high natural risk for lymphomas, makes therapeutic approach even more complex.
24213625 Advances in the pathogenesis and treatment of systemic juvenile idiopathic arthritis. 2014 Jan Systemic juvenile idiopathic arthritis (s-JIA) is clinically distinct from other types of JIA. It is typified by extraarticular features such as quotidian fevers, rash, splenomegaly, lymphadenopathy, laboratory abnormalities (including leukocytosis, thrombocytosis, anemia, hyperferritinemia, and elevated inflammatory markers), and a close association with the macrophage activation syndrome. Recent investigations have highlighted dysregulation of the innate immune system as the critical pathogenic driver of s-JIA. Key innate immune mediators of s-JIA are the macrophage-derived cytokines interleukin-1 (IL-1) and IL-6. Increased understanding of the roles of IL-1 and IL-6 in the pathogenesis of s-JIA has led to major changes in therapeutic options. Until recently, the most commonly used medications included corticosteroids, methotrexate, and tumor necrosis factor (TNF) inhibitors, which are incompletely effective in most cases. Newer biologic agents targeting IL-1 and IL-6 have proven very effective in treating s-JIA and in minimizing corticosteroid exposure. Here we review recent advances in the understanding of the pathogenesis of s-JIA and the recent clinical trials that have revolutionized the care of children with s-JIA.
25538339 Autoimmune hepatitis as an adverse effect of long-term methotrexate therapy. 2014 Nov Methotrexate (MTX) is one of the most commonly used medicines in the treatment of psoriatic arthritis. The drug can produce steatosis and cirrhosis. Autoimmune hepatitis is a rare and serious adverse effect. We describe the case of a 53-year-old woman who developed autoimmune hepatitis after a long-term use of MTX for psoriatic arthritis. Hepatitis was completely resolved 4 months after stopping this drug. The pathophysiologic mechanisms of a drug-induced autoimmunity are unclear and complex. This report confirms the need to monitor liver enzymes carefully in patients using long-term treatment with MTX for psoriasis or rheumatoid arthritis.
23664559 Methotrexate therapy may prevent the onset of uveitis in juvenile idiopathic arthritis. 2013 Sep OBJECTIVE: To evaluate whether early treatment with methotrexate (MTX) prevents the onset of uveitis in children with juvenile idiopathic arthritis. STUDY DESIGN: The clinical charts of all consecutive patients seen between January 2002 and February 2011 who had a disease duration <1 year at first visit and had received a stable management for at least 2 years with or without MTX were reviewed. Patients who were given systemic medications other than MTX (except nonsteroidal anti-inflammatory drugs) were excluded. Patients with systemic arthritis, rheumatoid factor-positive arthritis, or enthesitis-related arthritis were also excluded. In each patient, the 2-year follow-up period after first visit was examined to establish whether uveitis had occurred. RESULTS: A total of 254 patients with a median disease duration of 0.3 year were included. Eighty-six patients (33.9%) were treated with MTX, whereas 168 patients (66.1%) did not receive MTX. During the 2-year follow-up, 211 patients (83.1%) did not develop uveitis, whereas 43 patients (16.9%) had uveitis a median of 1.0 year after the first visit. The frequency of uveitis was lower in MTX-treated than in MTX-untreated patients (10.5% vs 20.2%, respectively, P = .049). Survival analysis confirmed that patients treated with MTX had a lower probability of developing uveitis. CONCLUSION: Early MTX therapy may prevent the onset of uveitis in children with juvenile idiopathic arthritis. Because our study may be affected by confounding by indication, the potential of MTX to reduce the incidence of ocular disease should be investigated in a randomized controlled trial.
25574418 Gout initially mimicking rheumatoid arthritis and later cervical spine involvement. 2014 Gout is clinically characterized by episodes of monoarthritis, but if not treated properly, it can lead to a chronic polyarthritis, which may eventually mimic rheumatoid arthritis (RA). We present the case of a 59-year-old man, with a history of symmetrical polyarthritis of the large and small joints with later development of subcutaneous nodules, which was initially misdiagnosed as RA, being treated with prednisone and methotrexate for a long period of time. He complained of occipital pain and paresthesia in his left upper limb, and computed tomography (CT) and magnetic resonance imaging (MRI) revealed the presence of an expansive formation in the cervical spine with compression of the medulla. He was admitted for spinal decompressive surgery and the biopsy specimen demonstrated a gouty tophus. Chronic gout can mimic RA and rarely involves the axial skeleton, and thus its correct diagnosis and the implementation of adequate therapy can halt the development of such damaging complications.