Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial.

OBJECTIVES: To compare the benefits of a tight-control/treat-to-target strategy (TC/T2T) in axial spondyloarthritis (axSpA) with those of usual care (UC). METHODS: Pragmatic, prospective, cluster-randomised, controlled, open, 1-year trial (NCT03043846). 18 centres were randomised (1:1). Patients met Axial Spondylo Arthritis International Society (ASAS) criteria for axSpA, had an Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1, received non-optimal treatment by non-steroidal anti-inflammatory drugs and were biologic-naive. INTERVENTIONS: (1) TC/T2T: visits every 4 weeks and prespecified strategy based on treatment intensification until achieving target (ie, ASDAS <2.1); (2) UC: visits every 12 weeks and treatment at the rheumatologist's discretion. MAIN OUTCOME: Percentage of patients with a ≥30% improvement on the ASAS-Health Index (ASAS-HI). Other efficacy outcomes and adverse events were recorded. A health economic evaluation was performed. STATISTICAL ANALYSIS: Two-level mixed models were used to estimate efficacy outcomes. Cost-effectiveness was assessed by the incremental cost per quality-adjusted life-year (QALY) gained for TC/T2T versus UC. RESULTS: 160 patients were included (80/group). Mean (SD) age was 37.9 (11.0) years and disease duration was 3.7 (6.2) years; 51.2% were men. ASDAS at inclusion was 3.0 (0.7), and ASAS-HI was 8.6 (3.7). ASAS-HI improved by ≥30% in 47.3% of the TC/T2T arm and in 36.1% of those receiving UC (non-significant). All secondary efficacy outcomes were more frequent in the TC/T2T arm, although not all statistically significant. Safety was similar in both arms. From a societal perspective, TC/T2T resulted in an additional 0.04 QALY, and saved €472 compared with UC. CONCLUSION: TC/T2T was not significantly superior to UC for the primary outcome, while many secondary efficacy outcomes favoured it, had a similar safety profile and was favourable from a societal health economic perspective. TRIAL REGISTRATION NUMBER: NCT03043846.

Evaluation of Financial Conflicts of Interest Among Physician-Authors of American College of Rheumatology Clinical Practice Guidelines.

OBJECTIVE: Clinical practice guidelines (CPGs) underpin patient care, and ideally authors of these guidelines would be free from outside influence. However, it has been shown many times that authors of professional society CPGs receive large sums of money from industry drug companies, creating financial conflicts of interest. This study investigated industry payments catalogued in the Open Payments Database (OPD) that have been received by authors of the American College of Rheumatology (ACR) CPGs. METHODS: Guidelines on the ACR web site that were published during or after August 2014 were used to retrieve the list of authors. All general, research, associated research, and ownership payments reported on the OPD between the date of publication of the CPG and 12 months prior were extracted in a parallel and blinded manner by 2 investigators. RESULTS: Of the 89 US-based physician-authors from the 5 ACR CPGs identified within the study timeframe, 56 (62.9%) had received at least 1 payment according to OPD records. These 56 authors had received a median of $522 (interquartile range $119-2,500), which, combined, was a total of $9,728,751. Nineteen authors had received at least 1 industry payment relevant to the CPG recommendations, for a median amount of $748 and a total of $1,961,362 in relevant payments. Of the total relevant payments received, a significant proportion was undisclosed (for ACR CPGs during or after August 2014, undisclosed payments were $699,561, or 35.7% of the total). CONCLUSION: Fewer than one-half of the US-based physician-authors of ACR CPGs during or after August 2014 had received guideline-relevant industry payments. Nonetheless, a substantial proportion of the money received was not disclosed. Conflict of interest disclosure is a bare minimum requirement, and more permanent solutions may include divestiture or inclusion of more nonconflicted authors.

Scoring magnetic resonance imaging (MRI) inflammation and structural lesions in sacroiliac joints of patients with axial spondyloarthritis: assessment of all MRI slices of the cartilaginous compartment versus standardized six or five slices.

Objectives: The Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joint (SIJ) scoring system assesses six or five (6/5) semicoronal magnetic resonance imaging (MRI) slices for inflammation/structural lesions in patients with axial spondyloarthritis (axSpA). However, the cartilaginous SIJ compartment may be visible in a few additional slices. The objective was to investigate interreader reliability, sensitivity to change, and classification of MRI scans as positive or negative for various lesion types using an 'all slices' approach versus standard SPARCC scoring of 6/5 slices.Method: Fifty-three axSpA patients were treated with the tumour necrosis factor inhibitor golimumab and followed with serial MRI scans at weeks 0, 4, 16, and 52. The most anterior and posterior slices covering the cartilaginous compartment and the transitional slice were identified. Scores for inflammation, fat metaplasia, erosion, backfill, and ankylosis in the cartilaginous SIJ compartment were calculated for the 'all slices' approach and the 6/5 slices standard.Results: By the 'all slices' approach, three readers scored mean 7.2, 7.7, and 7.0 slices per MRI scan. Baseline and change scores for the various lesion types closely correlated between the two approaches (Pearson's rho ≥ 0.95). Inflammation score was median 13 (interquartile range 6-21, range 0-49) for 6/5 slices versus 14 (interquartile range 6-23, range 0-69) for all slices at baseline. Interreader reliability, sensitivity to change, and classification of MRI scans as positive or negative for various lesion types were similar.Conclusion: The standardized 6/5 slices approach showed no relevant differences from the 'all slices' approach and, therefore, is equally suited for monitoring purposes.

[Methods of efficacy assessment of the knee joint radiosynoviorthesis- personal experience].

OBJECTIVE: Introduction: Radiosynoviorthesis (RS) is local method of treatment of remittent joint effusions among patients who obtained general improvement after disease modifying anti-rheumatic drugs therapy but one or a few joints stay resistant to this treatment and intraarticular corticosteroids injections. The aim: The attempt to identification methods of efficacy assessment of the 90yttrium knee joint RS. PATIENTS AND METHODS: Material and methods: The study group consisted of 43 patients with rheumatoid arthritis (RA) and 19 patients with inflammatory spondyloarthropaties (SPA) where 8 patients were treated for ankylosing spondylitis (AS), 4 for psoriatic arthritis (PsA) and 7 due to undifferentiated inflammatory spondyloarthropaties (USPA). The efficacy of RS was measured subjectively by the patient, physically by the physician and with the help of chosen scores (DAS28), questionnaires (HAQ), laboratory parameters [ESR, level of CRP, osteoprotegerin (OPG), serum amyloid A (SAA), hialuronic acid (HA)] and three-phase bone scintigraphy of affected knee joints. RESULTS: Results: In RA patients very good results - no knee effusion were obtained in 25 (58,1%) joints, good results - minimal effusion in 10 (23,3%) knees and lack of improvement in 8 (18,6%) patients. Cumulatively very good and good results were obtained in 35 (81,4%) treated knee joints. In SPA patients very good results were noted in 12 (63,2%), good in 5 (26,3%), lack of improvement in 2 (10,5%) patients. Cumulatively very good and good results were obtained in 17 (89,5%) treated knee joints. We observed favorable profile changes of chosen scores (DAS28), questionnaires (HAQ), laboratory parameters (ESR, CRP, OPG, SAA, HA) and results of three-phase bone scintigraphy of knee joints. CONCLUSION: Conclusions: 90Yttrium RS is effective treatment of recurrent knee joints effusion in patients with RA i SPA. RS despite being local treatment decreases unspecific inflammatory process and systemic disease activity among patients with RA i SPA. The anatomic period of affected knee joints has negative correlation with treatment efficacy. 90Yttrium RS is safe procedure, favourable profile changes of cartilage and bone turn-over markers after therapy indicates protective influence of RS on these structures. The treatment response based on physical examination, subjective patient's evaluation, acute phase laboratory parameter levels and appropriate scores, questionnaires and imaging exams is fast and long-lasting.

Stability of fatigue, pain, patient global assessment and the Bath Ankylosing Spondylitis Functional Index (BASFI) in spondyloarthropathy patients with stable disease according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

The study objective was to examine natural variation of the patient-reported outcome measures fatigue, pain, patient global assessment (PaGl) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with stable axial spondyloarthropathy (ax-SpA) defined on the basis of the Bath Spondylitis Ankylosing Disease Activity Index (BASDAI). 107 TNF-inhibitor treated stable ax-SpA patients were identified in the Danish rheumatology registry (DANBIO). According to the Assessment of SpondyloArthritis international Society (ASAS) response criteria, stable disease was defined as a change in BASDAI < 20 between two consecutive visits. Data on BASDAI, fatigue, pain, PaGl and BASFI (0-100) from such two visits were extracted for each patient. Lower and upper 95% limits of agreement (LLoA;ULoA) and the mean of intra-individual differences (the bias) were computed for each measure. Associations were described by linear correlations and standard errors of estimation. Mean BASDAI was 35.6 ± 23.8, mean BASDAI change 0.0 ± 9.7 (range - 19 to 19) and mean inter-visit time duration 16 ± 13 weeks. LLoA;ULoA [bias] for fatigue was - 37.4;36.2 [- 0.6], for pain - 34.1;32.5 [- 0.8], for PaGl - 35.7;32.9 [- 1.4] and for BASFI - 23.2;22.6 [- 0.3]. Intra-individual differences in fatigue, pain, BASFI and PaGl were not correlated with the inter-visit time duration, were poorly inter-correlated and were poorly correlated with baseline values and with changes in BASDAI. In conclusion, natural variation of patient-reported outcome measures was substantial and unpredictable in individual ax-SpA patients in steady state defined on the basis of BASDAI. Consequently, observed changes in the daily clinic should be interpreted with caution.

Should axial spondyloarthritis without radiographic changes be treated with anti-TNF agents?

A spectrum of disease extends beyond the rigid confines of ankylosing spondylitis (AS). Axial spondyloarthritis (axSpA) encompasses non-radiographic axSpA (nr-axSpA) in individuals without established radiographic changes but with other clinical/imaging axSpA features and AS in those with definite sacroiliac joint changes on pelvic X-rays. A broad consensus about the management of nr-axSpA is emerging among clinicians, but the evidence base remains open to question. To explore whether nr-axSpA and AS should be treated similarly, we examined the literature on their prevalence, natural history, disease burden, and treatment. There is strong evidence that nr-axSpA and AS are expressions of the same disease. Approximately 10% of patients with nr-axSpA will develop radiographic disease over 2 years; after >20 years, the figure may exceed 80%. Nr-axSpA patients have lower CRP and less spinal inflammation on MRI than AS patients but similar disease activity, pain, and quality-of-life impairment. Most patients with nr-axSpA manage well with conservative treatment, but a minority has severe disabling symptoms. Anti-TNF therapy has demonstrated similar efficacy and safety in nr-axSpA and AS. Current evidence does not clearly indicate that anti-TNF treatment can inhibit or limit bony progression of AS, the basis of conservative and anti-TNF treatment is control of symptoms and function. For some patients with nr-axSpA, the need for powerful treatments is as great as in some with AS; thus, treatment of axSpA should be consistent across the axSpA spectrum with anti-TNF agents being available, irrespective of radiographic change, according to the same criteria as those applied to AS.

Counting Costs under Severe Financial Constraints: A Cost-of-Illness Analysis of Spondyloarthropathies in a Tertiary Hospital in Greece.

OBJECTIVE: To investigate the total annual direct cost of patients with spondyloarthritis (SpA) in Greece. METHODS: Retrospective study with 156 patients diagnosed and followed up in the rheumatology clinic of the University Hospital of Ioannina. Sixty-four had ankylosing spondylitis (AS) and 92 had psoriatic arthritis (PsA). Health resource use for each patient was elicited through a retrospective chart review that documented the use of monitoring visits, medications, laboratory/diagnostic tests, and inpatient stays for the previous year from the date that the review took place. Costs were calculated from a third-party payer perspective and are reported in 2014 euros. RESULTS: The mean ± SD annual direct cost for the patients with SpA reached €8680 ± 6627. For the patients with PsA and AS, the cost was estimated to be €8097 ± 6802 and €9531 ± 6322, respectively. The major cost was medication, which represented 88.9%, 88.2%, and 89.3% of the mean total direct cost for SpA, AS, and PsA, respectively. The annual amount of the scheduled tests for all patients corresponded to 7.5%, and for those performed on an emergency basis, 1.1%. Further, the cost for scheduled and emergency hospitalization, as well as the cost of scheduled visits to an outpatient clinic, corresponded to 2.5% of the mean total annual direct cost for the patients with SpA. CONCLUSION: SpA carries substantial financial cost, especially in the era of new treatment options. Adequate access and treatment for patients with SpA remains a necessity, even in times of fiscal constraint. Thus, the recommendations of the international scientific organizations should be considered when administering high-cost drugs such as biological treatments.

[Analisis of the budget impact of adalimumab and etanercept in rheumatoid arthritis and spondyloarthropathies]. / Análisis del impacto presupuestario de adalimumab y etanercept en artritis reumatoide y espondiloartropatías.

PURPOSE: To assess the economic impact derived from the widening of the administration intervals of adalimumab (ADA) and etanercept (ETN) for the treatment of rheumatoid arthritis (RA) and spondyloarthropathies (SAP) at our working environment. MATERIAL AND METHODS: A budget impact model (BIM) was developed to estimate the economic impact that would have widening the usual administration intervals of ADA, 40 mg every 2 weeks and ETN, 50 mg weekly (scenario A), to ADA, 40 mg every 3 weeks, and ETN, 50 mg every 2 weeks (scenario B) according to the guidelines and recommendations applied to these studies, specifying the target population, the study perspective, the temporal horizon, and analysing the study robustness by a threshold univariate sensitivity analysis. RESULTS: 71 patients were included in the study. The application of the BIM showed yearly savings for ADA and ETN of 19.784 ??and 38.271 ?, respectively. The net cost, that is to say the saving that this would imply within the temporal horizon considered (2 years), was 116.110 ?. The sensitivity analysis showed that the estimated BIM for the study period was very robust since the net result in the different scenarios varied very little, being negative in the new scenarios. CONCLUSIONS: widening the administration intervals of ADA and ETN to every 3 weeks and 2 weeks respectively, would be a strategy that would allow generating savings in the hospital budget close to 116.110 ??for the temporal horizon considered, achieving this way optimization of the treatment with these two drugs.

Objetivo: Evaluar el impacto económico derivado de la ampliación de los intervalos de administración de adalimumab (ADA) y etanercept (ETN), en el tratamiento de la artritis reumatoide (AR) y espondiloartropatias (EAP) en nuestro ámbito de trabajo. Material y método: Se desarrolló un modelo de impacto presupuestario (MIP) para estimar la repercusión económica que tendría la ampliación en los intervalos habituales de administración de ADA 40 mg cada dos semanas y ETN 50 mg semanal (escenario A), por ADA 40 mg cada tres semanas y ETN 50 mg cada dos semanas (escenario B) de acuerdo a las guías y recomendaciones que se aplican a estos estudios, especificando la población diana, la perspectiva del estudio, el horizonte temporal y analizando la robustez del estudio a través de un análisis de sensibilidad univariante de tipo umbral. Resultados: Se incluyeron un total de 71 pacientes en el estudio. La aplicación del MIP mostró unos ahorros anuales para ADA y ETN de 19.784??y 38.271 ??respectivamente. El coste neto, es decir, el ahorro que esto supuso en el horizonte temporal considerado (dos años) ascendió a 116.110 ?. El análisis de sensibilidad realizado mostró que el MIP estimado para el periodo de estudio fue muy robusto ya que el resultado neto en diferentes escenarios apenas variaba, manteniéndose negativo en los nuevos escenarios. Conclusiones: La ampliación de los intervalos de administración de ADA y ETN cada tres semanas y dos semanas respectivamente, sería una estrategia que permitiría generar ahorros en el presupuesto hospitalario cercanos a los 116.110 ??en el horizonte temporal considerado, consiguiendo así una optimización del tratamiento con estos fármacos.

A questionnaire survey of patient experience with the Rheumatology Monitoring Clinic in Singapore.

AIM: The concept of a pharmacist/advanced practice nurse (APN)-led Rheumatology Monitoring Clinic (RMC) is a novel service in Singapore; we therefore conducted a questionnaire survey of patient experience. METHODS: Patients attending the RMC were provided with a set of questionnaires. As a substudy, a separate questionnaire was given to the rheumatologists and therapists conducting the RMC. RESULTS: Of the 105 patients surveyed, a total of 97 (92.4%) patients were satisfied/strongly satisfied with the overall service, and none were dissatisfied; 96% felt that the pharmacists/APNs provided clear, detailed information about their disease and medication, while 92% of patients were confident they knew what side-effects were possible. Ninety-two percent and 93% of patients were more likely to adhere to treatment, and were willing to come back for follow-up at the RMC, respectively. There was no difference in patient satisfaction in the average Likert summed scores, between the pharmacists and APNs. Age, gender, ethnicity and underlying disease did not exert any influence on the responses. All the rheumatologists surveyed were satisfied with the patients' management and the professionalism of the therapists. They opined that the RMC freed up time for them to see more complex cases. All the pharmacists/APNs concurred that the referrals were appropriately selected. CONCLUSIONS: We established the acceptability of a non-physician-led clinic in our local setting and highlighted the usefulness of having a routine clinic for monitoring medication toxicity and patient education. The RMC received positive feedback from patients, rheumatologists and allied health therapists, with a high degree of satisfaction among the respondents.

Assessment of efficacy of pamidronate in undifferentiated spondyloarthropathy (uSpA): a placebo control trial in a tertiary level center.

Undifferentiated spondyloarthropathy (uSpA) is a nonspecific form of spondyloarthropathy where nonsteroidal anti-inflammatory drugs (NSAIDs) and disease-modifying anti-rheumatic drugs are still mainstay of treatment. We evaluated the efficacy and adverse effect profile of pamidronate, in uSpA patients refractory to NSAIDs therapy. A case series of 87 patients fulfilling the modified Amor criteria for the diagnosis of uSpA, having active disease even after 3-month continuous therapy with two NSAIDs, were selected. Active disease was defined as a VAS score >50 in a scale of 0-100 in 3 out of four following parameters: patients' global assessment, pain, BASFI and BASDAI morning stiffness. Sixty-six patients among those were administered monthly pamidronate infusion (60 mg over 4 h in 500 ml of normal saline) for 6 months. Other 21 patients (placebo group) transfused with normal saline. Treatment outcome was assessed by comparing baseline and 6 months value of BASDAI, BASFI, BASMI, BAS-G, CRP and ESR in both groups and improvement by ASAS-20 and BASDAI-50. Among the 66 patients, 48 patients (72.73%) achieved ASAS-20 and 42 patients (63.64%) achieved BASDAI-50 response. Among the treatment group, mean ESR, CRP, BASDAI, BASFI, BAS-G and BASAMI reduced by 54.81 mm/h (64.95%), 3.94 mg/l (43.3%), 3.74 (48.38%), 3.73 (49.40%), 4.47 (58.97%) and 4.28 (58.15%), respectively, after treatment, whereas in placebo group, increased by 5.48 mm/h (6.34%), 0.34 mg/l (3.77%), 0.24 (3.02%), 0.45 (6.03%), 0.05 (0.67%) and 0.52 (7.13%), respectively, after 6 months. Intravenous pamidronate has very good efficacy for the treatment of uSpA.

Etanercept in spondyloarthopathies. Part II: safety and pharmacoeconomic issues.

Etanercept (ETN) and other anti-TNF-α agents have revolutionised the management of spondyloarthropathies (SpA). With the increasingly widespread and prolonged use of these drugs an assessment of their long-term safety is extremely important. An additional concern regarding biological agents is their higher costs compared with conventional drugs. We examined safety data regarding ETN from clinical reports, clinical trials, review articles, databases and registries. In addition, evidence was reviewed about the cost effectiveness of ETN in the treatment of patients with SpA. Our review suggests that ETN is well tolerated as long-term, continuous treatment of SpA with a favourable risk-benefit ratio maintained from 4 to 5 years. Diversity in structure and mode of action could explain some differences in the safety profile of ETN with respect to the other anti-TNF agents. In particular, ETN is less immunogenic and is less likely to induce tuberculosis re-activation than the other TNF-α antagonists. Although ETN is considerably more expensive than conventional therapy, it reduces direct and indirect costs associated to SpA by improving disease activity and quality of life. Recent pharmacoeconomic studies have demonstrated its cost-effectiveness in the treatment of SpA.

Power Doppler ultrasonography assessment of entheses in spondyloarthropathies: response to therapy of entheseal abnormalities.

OBJECTIVE: To investigate the response to therapy of entheseal abnormalities assessed with power Doppler (PD) ultrasound (US) in spondyloarthropathies (SpA). METHODS: A total of 327 patients with active SpA who were starting anti-tumor necrosis factor (TNF) therapy were prospectively recruited at 35 Spanish centers. A PDUS examination of 14 peripheral entheses was performed by the same investigator in each center at baseline and at 6 months. The following elementary lesions were assessed at each enthesis (presence/absence): morphologic abnormalities (hypoechogenicity and/or thickening), entheseal calcific deposits, cortical abnormalities (bone erosion and/or proliferation), adjacent bursitis and intraenthesis and perienthesis (tendon body and/or bursa) PD signal. Response to therapy of each elementary lesion was assessed by calculating change in the cumulative presence from baseline to 6 months. Intraobserver reliability of PDUS was evaluated by blindly assessing the stored baseline images 3 months after the real-time examination. RESULTS: Complete data were obtained on 197 patients who received anti-TNF therapy for 6 months. In 91.4% of the patients there were gray-scale or PD elementary lesions at baseline and at 6 months. Cumulative entheseal morphologic abnormalities, intraenthesis PD, perienthesis PD, and bursitis showed a significant decrease from baseline to 6 months (p < 0.05). There was high intraobserver reliability for all elementary lesions (interclass correlation coefficient > 0.90, p < 0.0005). CONCLUSION: Entheseal morphologic abnormalities, PD signal, and bursitis were US abnormalities that were responsive to anti-TNF therapy in SpA. PDUS can be a reproducible method for multicenter monitoring of therapeutic response in enthesitis of SpA.

The evidence for whole-spine MRI in the assessment of axial spondyloarthropathy.

In the past decade, fat-suppression MRI techniques have been increasingly used for the assessment of axial-SpA. Indeed, newly proposed classification criteria have suggested the inclusion of fat-suppression MRI for the evaluation of the SI joint in inflammatory back pain (IBP) of suspected axial-SpA. However, recent data on the whole spine have identified certain MRI spinal lesions to be highly diagnostic of axial-SpA; that the SI joint can be spared in axial-SpA; and that IBP may originate in the lumbar spine rather than SI joint. Therefore, it is proposed that MRI of the whole spine and not just the SI joint should now become a routine part of the assessment of axial-SpA. Not only is spinal MRI of great diagnostic utility in axial-SpA but there is also increasing evidence to suggest that it can play a significant role in the management, in particular directing anti-TNF therapy in AS, and also it may be prognostically useful in axial-SpA. With the wider availability, improving technology and falling cost of MRI, and the difficulty that clinical assessment of axial-SpA poses, especially in early disease, there is now a strong case for the use of whole-spine MRI in the diagnosis and management of axial-SpA.

Prospective assessment of body weight, body composition, and bone density changes in patients with spondyloarthropathy receiving anti-tumor necrosis factor-alpha treatment.

OBJECTIVE: To determine the changes in body weight, body composition, and bone density in patients with spondyloarthropathy (SpA) receiving anti-tumor necrosis factor-alpha (TNF-alpha) treatment. METHODS: One hundred six patients with SpA (80 men, 26 women) aged 20-71 years were included in a 2-year prospective open study. Fifty-nine patients received infliximab (3 or 5 mg/kg/infusion each 6 or 8 weeks); and 47 patients received etanercept (25 mg twice a week) because of persistent active disease despite an optimal treatment, according to ASsessments in Ankylosing Spondylitis Working Group criteria. Body weight, total body composition (lean mass, fat mass), and spine and femoral bone mineral density (BMD; dual-energy x-ray absorptiometry) were measured at baseline and at 1 and 2 years. RESULTS: There was a significant increase in body weight after 1 year (2.2 +/- 3.9 kg, i.e., 3.4%; p < 0.0001) and 2 years (2.2 +/- 4.7 kg, 3.5%; p < 0.0001), mostly due to a significant gain in fat mass at 1 year (1.4 +/- 2.6 kg, 12.1%; p < 0.0001) and 2 years (1.5 +/- 3.1 kg, 14.5%, p < 0.0001). Gain in lean mass was also significant at 1 year (0.8 +/- 2.2 kg, 1.9%; p < 0.0001) and 2 years (0.9 +/- 2.5 kg, 2%; p < 0.0001). At 2 years, lumbar spine and femur BMD increased: +5.8 +/- 13% (p < 0.0001) and +2.26 +/- 4.5% (p = 0.001), respectively. CONCLUSION: This 2-year prospective study showed a significant increase in body weight at 1 year and 2 years, mostly due to a gain in fat mass and a significant increase in BMD, in patients with SpA receiving anti-TNF-alpha treatment.