Pleural effusion in psoriatic arthritis patients: a case series and review of the literature.

Psoriatic arthritis (PsA) is a chronic inflammatory disease associated with psoriasis. Pulmonary involvement is a rare extra-articular manifestation of the disease characterized by rigidity of the chest wall and apical pulmonary fibrosis. Pleural effusion is uncommon in PsA. We present four cases of patients with PsA who developed pleural effusions. We report for the first time a PsA patient who was drug-naïve and developed unilateral pleuritis. We also describe one PsA case with pleuritis while he was on methotrexate (MTX) and two PsA cases on tumor necrosis factor (TNF) inhibitors. The literature review revealed six cases with pleural effusion, which were drug-induced. These patients presented pleural effusions while they were treated with MTX (2 patients) and TNF inhibitors (4 patients). In PsA patients with pleuritis, a detailed investigation to rule out infections is necessary. In addition, increased pharmacovigilance will detect cases of drug-induced serositis.

Clinical, Serological and Immunological Characteristics in Greek Patients with Psoriatic Arthritis: The Role of IL-17, IL-23, and Sclerostin.

Psoriatic arthritis (PsA) is an inflammatory form of arthritis that belongs to the family of spondyloarthritis (SpA) and is related to skin psoriasis. The incidence and prevalence of the disease vary considerably between countries. PsA is classified into axial PsA and peripheral PsA, with a wide range of other extra-articular manifestations. Although the aetiology of the disease is unknown, genetic, environmental, and immunologic factors appear to affect its appearance. In recent years, the role of the immune system in the pathogenesis of PsA has been increasingly investigated. Specific cytokines such as tumour necrosis factor (TNF), interleukin (IL-) 17 and IL-23, play an essential role affecting joint structures. This observation led to the emergence of tumour necrosis factor inhibitors (TNFi) that offer considerable therapeutic benefit to PsA patients. However, chronic inflammation causes bone loss, while new bone formation may also occur in both peripheral and axial skeleton. The molecular mechanisms underlying these processes have not yet been fully understood. So far, the role of the Wnt/ß-catenin pathway and its inhibitors (Dickkopf and sclerostin) has been evaluated in ankylosing spondylitis (AS), but in PsA has not been studied sufficiently. The present study aims to investigate the epidemiological characteristics and clinical features (articular and extra-articular manifestations) as well as the treatment of PsA patients in the region of northwestern (NW) Greece. It also aims to evaluate the role of specific cytokines and sclerostin in patients with PsA, giving evidence to possible future biomarkers or even therapeutic targets for the disease.

Adalimumab-induced myasthenia gravis: case-based review.

Myasthenia gravis (MG) is an autoimmune disease characterised by the presence of acetylcholine receptor antibodies and by blocking the transmission of the signal in the neuromuscular junction causing muscle weakness. It can be associated with several autoimmune diseases and certain drugs, between them Etanercept an anti-tumour necrosis factor (TNF) agent. A 42-year-old woman with rheumatoid arthritis (RA) refractory to methotrexate, was treated with adalimumab (ADA), a human monoclonal antibody against the TNF, in a dosage scheme of 40 mg every 14 days subcutaneously. The patient responded well to ADA therapy with sustained remission for 18 months when she developed blurred vision and eyelid ptosis of the left eye. The diagnosis of ocular MG was made. ADA has been discontinued and she started a treatment with pyridostigmine showing an excellent response and complete remission within a 2-month period. This is the first report making an association of ADA and ocular MG. Thus, rheumatologists dealing with patients treated with TNF inhibitors should be aware of the possible development of neurological adverse events, among them MG.

Eight-year survival study of first-line tumour necrosis factor α inhibitors in rheumatoid arthritis: real-world data from a university centre registry.

OBJECTIVE: This study aimed to investigate the efficacy, safety and survival of TNF-α inhibitors in patients with RA. METHODS: A total of 178 patients >18 years of age were treated with TNF-α inhibitors. A total of 74 patients were treated with infliximab, 75 with adalimumab and 29 with etanercept. Each patient was followed-up for a period of 8 years. RESULTS: Anti-TNF-α therapy resulted in rapid clinical improvement. The rate of good/moderate response according to EULAR response criteria for the index 28-joint DAS with CRP in the first 6 months was 82% for infliximab, 89.6% for adalimumab and 95.6% for etanercept. The rate of withdrawal in 8 years was 80% for patients on infliximab, 61.4% for patients on adalimumab and 47.6% for patients on etanercept. The main reasons for discontinuation were allergic reactions for infliximab (rate of discontinuation 25.7%) and inefficacy for adalimumab and etanercept (17.5% and 23.8%, respectively). Systemic allergic reactions and infections were significantly more frequent in the infliximab group (P < 0.05 and P < 0.001, respectively). However, there was no significant difference among the three drugs concerning serious infections. According to Kaplan-Meier survival analysis, a significantly faster withdrawal for infliximab patients was depicted compared with adalimumab (P = 0.003) and etanercept (P = 0.019), while adalimumab and etanercept were not statistically different (P = 0.089). CONCLUSIONS: TNF-α inhibitors establish an effective therapeutic option in RA showing an acceptable safety profile. Infections and allergic reactions appear more often with infliximab, while serious infections did not differ among them. RA patients treated with infliximab are more likely to discontinue treatment earlier compared with the other alternatives.

B cell depletion treatment decreases CD4+IL4+ and CD4+CD40L+ T cells in patients with systemic sclerosis.

Recent data suggests that rituximab may favorably affect skin fibrosis and lung function in patients with systemic sclerosis. Based on experimental data suggesting a key role of B and T cells in scleroderma we aimed to explore the effect(s) of rituximab treatment on T cell subpopulations. Fifteen patients with scleroderma who received rituximab treatment and six who received standard treatment alone were recruited. Peripheral CD4+IL4+, CD4+INFγ+, CD4+IL17+ and CD4+CD40L+ T cells were assessed using flow cytometry. Using ELISA, serum levels of IL4 were assessed. Skin CD4+IL4+ T cells were assessed with confocal microscopy from skin biopsies. Following rituximab treatment skin CD4+IL4+ T cells obviously decreased as seen with confocal microscopy. Moreover, peripheral CD4+IL4+ T cells decreased significantly compared to those from patients who received standard treatment alone: median (IQR): 14.9 (22.63-12.88) vs 7.87 (12.81-4.9)%, p = 0.005 and 9.43 (19.53-7.50)% vs 14.86 (21.96-6.75)%, p = NS at baseline and 6 months later respectively, whereas there was no difference in serum IL4 levels. Peripheral CD4+CD40L+ T cells also decreased significantly following rituximab treatment compared to those from patients who received standard treatment alone: median (IQR): 17.78 (25.64-14.44)% vs 8.15 (22.85-3.08)%, p = 0.04 and 22.13 (58.77-8.20)% vs 72.11 (73.05-20.45)%, p = NS at baseline and 6 months later respectively. Furthermore, peripheral CD4+INFγ+ and CD4+IL17+ T cells revealed no differences following rituximab treatment. Our study demonstrates a link between rituximab treatment and CD4+IL4+ T cell decrease both in the skin and peripheral blood of patients with SSc.

The impact of temporal artery biopsy for the diagnosis of giant cell arteritis in clinical practice in a tertiary university hospital.

BACKGROUND: Temporal artery biopsy (TAB) is useful in assisting with giant cell arteritis (GCA) diagnosis but lacks sensitivity. The aim of our study was to assess the diagnostic impact of TAB histology in patients with suspected GCA on hospital admission. METHODS: A prospectively maintained database was queried for all TABs performed between 1-1-2000 until 31-12-2017 at the University Hospital of Ioannina. Thus, inclusion criteria were made on the grounds of every patient that underwent a TAB during the above-mentioned period, regardless of demographic, clinical and laboratory data. RESULTS: Two hundred forty-five TABs were included (149 females and 96 males), with a mean age of 64.5 (±3.5) years. The mean symptoms duration until admission to the hospital was 8.6 (±1.3) weeks and all had elevated acute phase reactants on admission. The reasons of admission were fever of unknown origin (FUO) in 114 (46.5%) patients, symptoms of polymyalgia rheumatica (PMR) in 84 (34.3%), new headache in 33 (13.5%), anemia of chronic disease (ACD) in 8 (3.32%) and eye disturbances in 6 (2.5%) patients. Positive results were found in 49 (20%) TABs. More specifically, in 14% of patients with FUO, 21% in those with PMR, while in patients with a new headache the percentage was 27%. Finally, 5 out of 6 (83.3%) of patients with ocular symptoms and only one (12.5%) of those suffering from ACD. Visual manifestations and FUO are correlated with a positive TAB. CONCLUSION: It seems that TAB is useful in assisting with GCA diagnosis, but lacks sensitivity.

Epidemiological characteristics of psoriatic arthritis.

Psoriatic arthritis (PsA) is a specific form of inflammatory arthritis associated with skin psoriasis. PsA makes part of a heterogeneous group of arthritides called the spondyloarthropathies. Several studies regarding the prevalence and incidence of PsA have been published during the last decades, showing a considerable variation of the disease occurrence among different populations. The purpose of this review is to discuss recent observations of epidemiological features for PsA patients. Thus, the literature was reviewed until May 2018 for studies regarding PsA epidemiology, classification criteria and risk factors for PsA development. Systematic reviews based on the international bibliography, are reporting the prevalence of the disease from 1/100.000 inhabitants in Japan to as high as 420/100.000 inhabitants in Italy. The annual incidence also varies, ranging from 1 to 23/100.000 inhabitants, while the average incidence rate is 6.5 cases/100.000 inhabitants. The random effect pooled PsA prevalence and incidence rates are 133/100.000 and 83/100.000 subjects respectively. Thus, a large heterogeneity between studies is observed. This variability could be explained by a number of factors such as the use of multiple and different classification criteria in the studies. Geographical variations are also observed regarding disease occurrence. Differences were found not only between different continents, but also within the same geographic regions. This could be explained by the different genetic background especially the distribution of the human leucocyte antigens. In addition, other factors such as environmental (infections, climate, sun exposure), dietary habits (fish oil consumption, Mediterranean diet) or life style habits (obesity, smoking), could explain the geographic variability in the prevalence estimates. The implementation of unanimous classification criteria and the conformation by the scientific community could lead to a better understanding of the disease epidemiology.

Comparative Analysis and Predictors of 10-year Tumor Necrosis Factor Inhibitors Drug Survival in Patients with Spondyloarthritis: First-year Response Predicts Longterm Drug Persistence.

OBJECTIVE: To evaluate the 10-year drug survival of the first tumor necrosis factor inhibitor (TNFi) administered to patients with spondyloarthritis (SpA) overall and comparatively between SpA subsets, and to identify predictors of drug retention. METHODS: Patients with SpA in the Hellenic Registry of Biologic Therapies, a prospective multicenter observational cohort, starting their first TNFi between 2004-2014 were analyzed. Kaplan-Meier curves and Cox regression models were used. RESULTS: Overall, 404 out of 1077 patients (37.5%) discontinued treatment (followup: 4288 patient-yrs). Ten-year drug survival was 49%. In the unadjusted analyses, higher TNFi survival was observed in patients with ankylosing spondylitis (AS) compared to undifferentiated SpA and psoriatic arthritis [PsA; significant beyond the first 2.5 (p = 0.003) years and 7 years (p < 0.001), respectively], and in patients treated for isolated axial versus peripheral arthritis (p = 0.001). In all multivariable analyses, male sex was a predictor for longer TNFi survival. Use of methotrexate (MTX) was a predictor in PsA and in patients with peripheral arthritis. Absence of peripheral arthritis and use of a monoclonal antibody (as opposed to non-antibody TNFi) independently predicted longer TNFi survival in axial disease because of lower rates of inefficacy. Achievement of major responses during the first year in either axial or peripheral arthritis was the strongest predictor of longer therapy retention (HR 0.33, 95% CI 0.26-0.41 for Ankylosing Spondylitis Disease Activity Score inactive disease, and HR 0.35, 95% CI 0.24-0.50 for 28-joint Disease Activity Score remission). CONCLUSION: The longterm retention of the first TNFi administered to patients with SpA is high, especially for males with axial disease. The strongest predictor of longterm TNFi survival is a major response within the first year of treatment.

Cancer diagnosis in a cohort of patients with Sjogren's syndrome and rheumatoid arthritis: a single-center experience and review of the literature.

BACKGROUND: With the development of modern therapies and better care of patients with autoimmune rheumatic diseases (ARDs) increased survival has been achieved. However, ARDs may share an association with risk of lymphomas and solid tumors. The increased cancer risk in these patients is mainly due to high inflammatory activity and severity of disease, rather than the immunosuppressive therapy. PATIENTS AND METHODS: We studied the coexistence or later development of cancer with ARDs in a retrospective audit of a reference university hospital and critically reviewed published literature. Fourteen out of 1,730 patients with rheumatoid arthritis (RA) and Sjogren's syndrome (SS) followed-up at the University Hospital of Ioannina over the last 33 years developed secondary malignancies, both solid tumors and lymphomas. RESULTS AND CONCLUSION: The most frequent cancer associated with ARDs is diffuse large B-cell lymphoma (DLBCL). The average risk of lymphoma in RA may be composed of a markedly increased risk in patients with most severe disease. Solid tumors were presented mainly in RA patients and renal cell carcinoma was the most frequently found.

Cardiovascular risk profile in patients with spondyloarthritis.

OBJECTIVES: The spondyloarthritides (SpA) are associated with an increased cardiovascular risk. We studied cardiovascular risk factors in patients with SpA. METHODS: The following risk factors were assessed in SpA patients and healthy controls: smoking, family history of premature ischemic heart disease, obesity, serum lipids, apolipoproteins, urate and carotid intima media thickness (IMT). RESULTS: Overall 150 patients (73 with ankylosing spondylitis [AS], 71 with psoriatic arthritis [PsA] and six with other SpA types) were included. Generally SpA patients were significantly more often smokers, while PsA patients had greater values of abdominal obesity. AS patients had significantly lower levels of triglyceride, HDL, ApoB, ApoE and Lp(a) and a higher atherogenic index (total cholesterol/HDL). PsA patients had significantly lower levels of HDL, ApoAI and ApoE, an elevated atherogenic index and higher serum urate. In multivariate analysis the atherogenic index was positively associated with SpA across all patient groups independently of smoking and other lipid parameters. Carotid IMT in SpA patients (0.71 mm) was higher than controls (0.63 mm, P=0.017), although after adjusting for smoking this ceased to be significant. Treatment of patients with previously untreated disease resulted in a small but significant decline in ApoB levels at 6 months (P=0.045), which, however, was no longer evident at 12 months. CONCLUSION: Spondyloarthritis patients are at a greater cardiovascular risk owing to the higher prevalence of smoking and a higher atherogenic index. PsA patients have more abdominal fat and higher urate levels. Immunosuppressive treatment of SpA produces minor and temporary effects on the lipid profile.

Comparative effectiveness and survival of infliximab, adalimumab, and etanercept for rheumatoid arthritis patients in the Hellenic Registry of Biologics: Low rates of remission and 5-year drug survival.

OBJECTIVE: To compare effectiveness, drug survival, and safety between infliximab, adalimumab, and etanercept, in a nationwide cohort of rheumatoid arthritis (RA) patients. METHODS: This study is a prospective cohort study of 1208 active RA patients. Effectiveness, drug survival, and serious adverse events during entire follow-up (median 2.9 years) were monitored. RESULTS: EULAR and CDAI responses were comparable between the three agents (EULAR good/moderate responses at 12 months ranged 76-79%). At 12 months, 15-23% achieved remission. For adalimumab and etanercept, adjusted hazard rate (HR) for EULAR/ACR remission (reference: infliximab) was 2.7 and 2.1 (95% confidence interval was 1.7-4.1 and 1.3-3.4, respectively); males (HR 1.6; 1.1-2.4), use of glucocorticoids (HR 2.0; 1.3-3.0), and swollen joint count >7 (HR 0.36; 0.24-0.55) were independent predictors. Five-year drug survival was 31%, 43%, and 49% for infliximab, adalimumab, and etanercept, respectively (p = 0.010). Infliximab was associated with significantly more withdrawals due to adverse events. Disease activity, CRP, and use of glucocorticoids predicted efficacy-related drug survival; age, use of methotrexate, and prior DMARDs failures predicted safety-related survival. Risk for serious infections was lower with adalimumab (odds ratio [OR] 0.62; 0.38-1.00) or etanercept (OR 0.39; 0.21-0.72) than infliximab, independent of the effects of age (OR 1.65; 1.37-2.00 per 10 years), tender joint count >10 (OR 1.86; 1.21-2.86), and glucocorticoids >35mg/week (OR 1.83; 1.12-2.99). CONCLUSIONS: Response rates were comparable among anti-TNF agents. Overall, 5-year drug survival was below 50%, with infliximab demonstrating increased safety-related discontinuations. Remission rates are low in clinical practice. Strategies to increase effectiveness and long-term survival of anti-TNF agents in RA are needed.

Fertility in male patients with seronegative spondyloarthropathies treated with infliximab.

OBJECTIVES: The majority of patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are affected during their peak reproductive years. Tumor necrosis factor (TNF)α plays a pivotal role in the pathogenesis of both diseases. Today, anti-TNFα blockers are an essential treatment for these patients. To identify male patients who achieved pregnancy development during their management with anti-TNFα blockers (infliximab). METHODS: We reviewed the data of 65 patients with AS and 30 patients with PsA who were followed-up in our rheumatology outpatients clinic and they were on infliximab therapy between January 2001 and December 2010. RESULTS: We identified overall seven male patients with AS and three male patients with PsA who had fathered 14 healthy infants. Moreover, we recognized one man with PsA who was on infliximab and on concomitant therapy with MTX at the time of conception, whose wife had to proceed to therapeutic abortion due to congenital abnormalities of the fetus (hydrocephalia), while she was on the first trimester of pregnancy. CONCLUSIONS: We described male patients with AS and PsA who demonstrated no fertility problems while they were on infliximab treatment. The data designated in this report provide some supportive evidence for the safe use of infliximab in male patients who are affected of those inflammatory diseases during their peak reproductive years.

Sustained clinical response in psoriatic arthritis patients treated with anti-TNF agents: a 5-year open-label observational cohort study.

OBJECTIVE: To investigate the efficacy, toxicity, and drug discontinuation in patients with psoriatic arthritis treated with anti-tumor necrosis factor agents. METHODS: Sixty-five patients with active disease were included in this open-label study. They had tender or swollen joint count ≥5, Psoriatic Arthritis Severity Index (PASI) score ≥10, and erythrocyte sedimentation rate ≥28 mm Hg/1st hour and/or C-reactive protein ≥10 mg/L. All were refractory to at least 2 disease-modifying antirheumatic drugs. Thirty were treated with infliximab, 25 with etanercept, and 10 with adalimumab. Infliximab (5 mg/kg body weight) was given intravenously at weeks 0, 2, 6, and every 8 weeks thereafter; etanercept was given subcutaneously (25 mg twice a week), while adalimumab was given subcutaneously (40 mg every other week) for a period of 5 years. Data concerning anti-tumor necrosis factor efficacy tolerability, adverse events, and drug discontinuation were recorded. The percentage of patients who achieved the Psoriatic Arthritis Response Criteria (PSARC), the improvement of PASI, the improvement according to the American College of Rheumatology (ACR) criteria, and the disease activity for 28 joint indices score (DAS-28) were recorded. RESULTS: After 5 years, PSARC was 60%, PASI 70 was 66.7%, PASI 90 was 63.3%, while ACR 50 was 56.7% for the patients treated with infliximab. Moreover, PsARC was 64%, PASI 70 and PASI 90 were 68%, while ACR 50 was 56% for those treated with etanercept. Furthermore, in the adalimumab group PsARC was 56%, PASI 70 and PASI 90 were 58% and 50%, respectively, while ACR 50 was 50%. Additionally, DAS-28 scores were significantly improved. Thirteen patients treated with infliximab, 6 with etanercept, and 5 patients with adalimumab were withdrawn. At the end of treatment, the survival of infliximab was 56.7%, for etanercept 76%, and for adalimumab 50%. CONCLUSION: All drugs were effective, safe, and well-tolerated. The clinical improvement was maintained through the 5 years with satisfying infliximab and adalimumab survival and high etanercept survival.

Maintained clinical response of infliximab treatment in ankylosing spondylitis: a 6-year long-term study.

OBJECTIVES: To investigate the efficacy, safety and drug discontinuation in patients with ankylosing spondylitis treated with infliximab, as well as the drug survival over a period of 6 years. METHODS: Forty patients with ankylosing spondylitis treated with infliximab were included in this open label study. All patients fulfilled the New York revised criteria for ankylosing spondylitis. Infliximab was given intravenously (5 mg/kg/body weight) at weeks 0, 2, 6 and every 8 weeks thereafter for a period of 6 years. Data concerning infliximab efficacy, tolerability, adverse events and drug discontinuation, were recorded. Clinical improvement according to the Bath Ankylosing Spondylitis Disease Activity Index 50% and the Ankylosing Spondylitis Assessment Study Group 20% and 40% were also recorded. RESULTS: A significant improvement in the Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Assessment Study Group scores was noted in the first year which sustained through the sixth year of treatment. More specifically, after the sixth year of treatment, Bath Ankylosing Spondylitis Disease Activity Index 50% was achieved by 65% of patients (26/40), Ankylosing Spondylitis Assessment Study Group 20% by 72.5% (29/40) and Ankylosing Spondylitis Assessment Study Group 40% was reached by 70% (28/40) of patients. Clinical improvement was associated with the reduction of acute phase reactants, such as C-reactive protein levels. After the first and the second year of treatment, the survival rate of infliximab reached 95%, after the third year it was 80%, while after the fourth year it was 72.5%, which was maintained throughout the fifth and sixth year of therapy. Five patients were increased the dose of infliximab and three of them had shortened the interval infusion. Overall, 11 patients were withdrawn during the observational period, three because of adverse events, two because of lack of efficacy, while six were lost from follow-up. CONCLUSION: Infliximab was effective, safe and well-tolerated in patients with ankylosing spondylitis. The clinical response was maintained for a period of 6 years, with high infliximab survival rate, reaching the percentage of 72.5%.

A case report of a psoriatic arthritis patient on hemodialysis treated with tumor necrosis factor blocking agent and a literature review.

This report seeks to describe the clinical efficacy and safety of infliximab in a patient with psoriatic arthritis on hemodialysis and to review the literature on the topic. We present a patient with psoriatic arthritis on hemodialysis treated with infliximab and we review the literature. Our case includes a patient with severe psoriasis and dactylitis with chronic renal failure requiring regular hemodialysis. At presentation the patient had a psoriasis area and severity index (PASI) score of 35.1 and dactylitis affecting the right thumb. Evaluation of laboratory parameters revealed a slight increase of erythrocyte sedimentation rate (21 mm/h) and a mild normocytic anemia (Hct 36.4). The rest of the laboratory and imaging tests were within normal limits. Infliximab was initiated at the loading dose of 5 mg/kg body weight at weeks 0, 2, 6, and every 8 weeks thereafter. On retreatment at week 14 the PASI score was measured to 3.4. After the conclusion of 6 months of treatment, the reduction of PASI score was sustained reaching the point of 0.8. In addition, dactylitis, as well as laboratory parameters, showed a striking improvement. On the other hand, during the same period of time, no changes of renal functions were noted and no complications were reported and the patient continued his hemodialysis on a regular basis. Our case is in accordance with other reports supporting that infliximab treatment in patients undergoing hemodialysis can be safe, well tolerated, and effective. However, larger trials are needed to prove its use in these patients.

Persistent clinical response of infliximab treatment, over a 4-year period in ankylosing spondylitis.

Our aim was to investigate the efficacy, toxicity, and drug discontinuation in patients with ankylosing spondylitis (AS) treated with infliximab. Thirty-five patients with AS, who were enrolled between June 2001 and December 2002 were treated with infliximab. All patients fulfilled the New York revised criteria for AS and had axial disease. Infliximab (5 mg/kg weight), was given intravenously at weeks 0, 2, 6, and every 8 weeks thereafter. If this failed to give an acceptable treatment response, the interval was shortened to 6 or 4 weeks. The patients were followed-up at predefined times according to a standardized protocol. Data concerning infliximab efficacy, tolerability, adverse events, interval, and drug discontinuation were all recorded. Clinical improvement according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50% and the Ankylosing Spondylitis Assessment Study group (ASAS) 40%, and ASAS 5/6 response criteria were recorded. Infliximab treatment resulted in a rapid improvement in the BASDAI and ASAS scores in the first year of the treatment, which sustained throughout the fourth year. More specifically, after the third year of treatment 17/35 (48.6%) of patients achieved BASDAI 50% response criteria, 19/35 (54.3%) attained the ASAS 40% and 15/35 (42.9%) reached the ASAS 5/6. After the fourth year of treatment BASDAI 50% was reached by 17/35 (48.6%) of patients, ASAS 40% by 17/35 (48.6%), while ASAS 5/6 was attained by 15/35 (42.9%). The clinical improvement was associated with the reduction of acute phase reactants as measured by C-reactive protein levels. After the first year of treatment, the "survival rate" of infliximab was 94.3%, after the second year was 91.4%, after the third year was 85.7% and even after 4 years of treatment still maintained high 77.9%. Six (17.1%) patients were withdrawn during the observational period. Three because of lack of efficacy, two because of allergic reactions and one lost from follow-up. Infliximab was effective, safe, and well tolerated in patients with AS. The clinical response was maintained for a period of 4 years and over, with infliximab survival of 77.9%.