A Delphi consensus on the management of Spanish patients with osteoporosis at high risk of fracture: OSARIDELPHI study.

The OSARIDELPHI study evaluated the level of agreement between specialists in osteoporosis regarding the management of patients with high-risk fractures in Spain. The results provide expert-based recommendations for prevention, diagnosis, and treatment related to fracture risk. Therefore, the study facilitates clinical decision-making for managing this patient's profile. PURPOSE: To evaluate the level of agreement between specialists in osteoporosis regarding the management of patients with high-risk fractures in Spain. METHODS: A two-round Delphi study was performed using an online survey. In round 1, panel members rated their level of agreement with assessments on a 9-point Likert scale. Item selection was based on acceptance by ≥ 66.6% of panel experts and the agreement of the scientific committee. In round 2, the same panelists evaluated non-consensus items in round 1. RESULTS: A total of 80 panelists participated in round 1; of these, 78 completed the round 2 survey. In round 1, 122 items from 4 dimensions (definition of fracture risk: 11 items, prevention and diagnosis: 38 items, choice of treatment: 24 items, and treatment-associated quality of life: 49 items) were evaluated. The consensus was reached for 90 items (73.8%). Panelists agreed that categorizing high risk, very high risk, or imminent risk determines secondary prevention actions (97.5%). Experts agreed that treatment with bone-forming drugs should be considered in case of a very high risk of fracture, and a sequential change to antiresorptive drugs should be made after 1-2 years (97.5%). Panelists also recommended corrective action plans for non-adherent patients to improve adherence (97.5%). A total of 131 items were finally accepted after round 2. CONCLUSION: This Delphi study provides expert-based recommendations on clinical decision-making for managing patients with osteoporosis at high risk of fracture.

Osteomalacia in Adults: A Practical Insight for Clinicians.

The term osteomalacia (OM) refers to a series of processes characterized by altered mineralization of the skeleton, which can be caused by various disorders of mineral metabolism. OM can be genetically determined or occur due to acquired disorders, among which the nutritional origin is particularly relevant, due to its wide epidemiological extension and its nature as a preventable disease. Among the hereditary diseases associated with OM, the most relevant is X-linked hypophosphatemia (XLH), which manifests in childhood, although its consequences persist into adulthood where it can acquire specific clinical characteristics, and, although rare, there are XLH cases that reach the third or fourth decade of life without a diagnosis. Some forms of OM present very subtle initial manifestations which cause both considerable diagnosis and treatment delay. On occasions, the presence of osteopenia and fragility fractures leads to an erroneous diagnosis of osteoporosis, which may imply the prescription of antiresorptive drugs (i.e., bisphosphonates or denosumab) with catastrophic consequences for OM bone. On the other hand, some radiological features of OM can be confused with those of axial spondyloarthritis and lead to erroneous diagnoses. The current prevalence of OM is not known and is very likely that its incidence is much higher than previously thought. Moreover, OM explains part of the therapeutic failures that occur in patients diagnosed with other bone diseases. Therefore, it is essential that clinicians who treat adult skeletal diseases take into account the considerations provided in this practical review when focusing on the diagnosis and treatment of their patients with bone diseases.

High incidence of clinical fragility fractures in postmenopausal women with rheumatoid arthritis. A case-control study.

OBJECTIVES: To estimate the incidence of clinical fragility fractures in postmenopausal women with rheumatoid arthritis (RA) and analyze risk factors for fracture. METHODS: Incidence of clinical fragility fractures in 330 postmenopausal women with RA was compared to that of a control population of 660 age-matched postmenopausal Spanish women. Clinical fractures during the previous five years were recorded. We analyzed associations with risk factors for fracture in both populations and with disease-related variables in RA patients. RESULTS: Median age of RA patients was 64 years; median RA duration was eight years. Sixty-nine percent were in remission or on low activity. Eighty-five percent had received glucocorticoids (GCs); 85 %, methotrexate; and 40 %, ≥1 biologic DMARD. Fifty-four patients and 47 controls had ≥1 major osteoporotic fracture (MOF). Incidence of MOFs was 3.55 per 100 patient-year in patients and 0.72 in controls (HR: 2.6). Risk factors for MOFs in RA patients were age, previous fracture, parental hip fracture, years since menopause, BMD, erosions, disease activity and disability, and cumulative dose of GCs. Previous fracture in RA patients was a strong risk for MOFs (HR: 10.37). CONCLUSION: Of every 100 postmenopausal Spanish women with RA, 3-4 have a MOF per year. This is more than double that of the general population. A previous fracture poses a high risk for a new fracture. Other classic risk factors for fracture, RA disease activity and disability, and the cumulative dose of GCs are associated with fracture development.

Abatacept in monotherapy vs combined in interstitial lung disease of rheumatoid arthritis-multicentre study of 263 Caucasian patients.

OBJECTIVE: To assess the efficacy and safety of abatacept (ABA) in monotherapy (ABAMONO) vs combined ABA [ABA plus MTX (ABAMTX) or ABA plus non-MTX conventional synthetic DMARDs (csDMARDs) (ABANON-MTX)] in RA patients with interstitial lung disease (ILD) (RA-ILD). METHODS: This was a restrospective multicentre study of RA-ILD Caucasian patients treated with ABA. We analysed in the three groups (ABAMONO, ABAMTX, ABANON-MTX) the following outcome variables: (i) dyspnoea; (ii) forced vital capacity (FVC) and diffusion capacity of the lung for the carbon monoxide (DLCO); (iii) chest high-resolution CT (HRCT); (iv) DAS28-ESR; (v) CS-sparing effect; and (vi) ABA retention and side-effects. Differences between basal and final follow-up were evaluated. Multivariable linear regression was used to assess the differences between the three groups. RESULTS: We studied 263 RA-ILD patients (mean ± s.d. age 64.6 ± 10 years) [ABAMONO (n = 111), ABAMTX (n = 46) and ABANON-MTX (n = 106)]. At baseline, ABAMONO patients were older (67 ± 10 years) and took higher prednisone dose [10 (interquartile range 5-15) mg/day]. At that time, there were no statistically significant differences in sex, seropositivity, ILD patterns, FVC and DLCO, or disease duration. Following treatment, in all groups, most patients experienced stabilization or improvement in FVC, DLCO, dyspnoea and chest HRCT as well as improvement in DAS28-ESR. A statistically significant difference between basal and final follow-up was only found in CS-sparing effect in the group on combined ABA (ABAMTX or ABANON-MTX). However, in the multivariable analysis, there were no differences in any outcome variables between the three groups. CONCLUSION: In Caucasian individuals with RA-ILD, ABA in monotherapy or combined with MTX or with other conventional-DMARDs seems to be equally effective and safe. However, a CS-sparing effect is only observed with combined ABA.

Performance of the ASAS Health Index for the Evaluation of Spondyloarthritis in Daily Practice.

OBJECTIVE: The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) is a tool designed to assess disease impact in spondyloarthritis (SpA), but its clinical performance is barely known. We aimed to test the clinimetric properties of ASAS HI in a real clinical setting. METHODS: This cross-sectional study included 111 consecutive patients with SpA. The measurement properties of ASAS HI were tested against conventional assessment measures. Convergent validity was assessed by Spearman rho correlations, while discriminative validity was analyzed through receiver-operating characteristic (ROC) curves. A multivariate regression analysis was designed to identify ASAS HI items associated with active disease. RESULTS: The average ASAS HI was 5.4 ± 3.8 (interquartile range 3-8). ASAS HI showed high convergent validity against other SpA measures (rho ≥ 0.70, p < 0.0005). The optimal criteria for detecting high/very high disease activity Ankylosing Spondylitis Disease Activity Score (ASDAS) categories was an ASAS HI score > 6, area under the ROC curve 0.86 (95% CI 0.78-0.92), positive likelihood ratio 7.3 (95% CI 3.1-17.1), p < 0.0001. The ASAS HI items significantly associated with Bath Ankylosing Spondylitis Disease Activity Index active disease were "I often get frustrated" (OR 9.2, 95% CI 1.2-69.4, p = 0.032), and "I sleep badly at night" (OR 7.7, 95% CI 1.4-41.6, p = 0.018). As for ASDAS, it was "pain sometimes disrupts my normal activities" (OR 8.7, 95% CI 1.7-45.2, p = 0.010). CONCLUSION: The ASAS HI is a useful and simple instrument for its application in daily practice. Given its good clinimetric properties, it could be used as an additional instrument to evaluate SpA.

Disease Activity in Psoriatic Arthritis Index and Psoriatic Arthritis Impact of Disease Questionnaire: correlation and sensitivity to change in a real clinical setting.

OBJECTIVES: The performance of many outcome measures for psoriatic arthritis (PsA) is almost unknown in real clinical practice. Our objective was to study the correlation and sensitivity to change of the Disease Activity in Psoriatic Arthritis (DAPSA) index and the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire in a real practice setting. METHODS: This was a prospective, open, non-controlled study that included 60 consecutive patients with PsA treated with ustekinumab. Most had been previously treated with one or more biologic therapeutic agents. The correlation (Spearman's rho coefficient) and the sensitivity to change [Standardized Mean Response (SMR)] of DAPSA and PsAID were studied. Effect size values of 0.20, 0.50 and 0.80 corresponded to low, moderate and high sensitivity to change, respectively. RESULTS: More than 70% of patients achieved therapeutic goals (21.7% were in remission and 50% in low disease activity according to DAPSA categories). Two out of three patients reached an acceptable symptomatic state (PsAID <4). The correlation between final values of both instruments was substantial (Spearman's rho: 0.62, p<0.0001). The SMR for the PsAID was 1.08 (0.95-1.21) and for DAPSA was 1.5 (1.37-1.63), both values corresponding to instruments with a high sensitivity to change (>0.80). The best PsAID cut-off value for identifying DAPSA remission was 3.32 with an area under the ROC curve of 0.82. CONCLUSIONS: DAPSA and PsAID seem to be useful instruments for a more comprehensive assessment of PsA in daily practice. Our results can help to disseminate the use of these instruments in the clinical practice of many rheumatologists.

Biological Dose Tapering in Daily Clinical Practice: A 10 Year Follow-up Study.

OBJECTIVE: To describe practice patterns, long-term outcome, and related factors, in relation to biological therapies tapering in rheumatoid arthritis (RA) patients in a well-controlled real-world setting. METHODS: An observational longitudinal retrospective 10-year study was conducted in all RA patients receiving biological agents in an RA clinic from May 2003 to October 2013. Biological treatment of patients with sustained DAS28<3.2 or SDAI<11 was tapered (dose down-titrated or interval widen) or discontinued as per practice protocol. Primary outcome of tapering was relapse, defined as an increase in DAS28≥1.2. Descriptive, survival analysis, and logistic regression analysis with first relapse as dependent variable were carried out. RESULTS: Of 193 RA patients on biological treatment (mean age 54±14 years, 81% women), tapering was applied in 106 (55%) and discontinuation in 34 (17.6%). During follow-up 38 patients relapsed (62%). Rate of relapse was 10% at 6 months, 19% at 12 months, 33.2% at 2 years and 50% after 5 years. Mean time in dose reduction was 4.5 years [95% confidence interval (95% CI): 3.7-5.3]. Six patients (15.7%) did not respond after reinstatement of full dose of biologic. In the multivariate analysis, pain [OR=1.26 (95% CI: 1.11-1.43); P<.001] and erythrocyte sedimentation rate (ESR) [OR=1.01 (95% CI: 1.00-1.03); P=.011] at baseline were associated with relapse after tapering. CONCLUSIONS: Tapering may be considered a long-term option in RA patients on biologics and low disease activity, especially if low ESR and pain scores are present at baseline; treatment reinstatement could be considered a safe option in case of relapse.

Analysis by Age Group of Disease Outcomes in Patients with Psoriatic Arthritis: A Cross-Sectional Multicentre Study.

OBJECTIVES: Elderly psoriatic arthritis (PsA) patients may show greater inflammatory activity and worse prognoses than patients of other ages. However, these patients may be at risk of receiving fewer systemic treatments. In this report, we have analysed disease outcomes in PsA by age groups. METHODS: This cross-sectional, multicentre study included 227 PsA patients under biological and non-biological systemic therapies. The study population was divided into four categories by age: < 40, 40‒49, 50‒65 and > 65 years. Physical functioning, disease activity, remission rates and disease impact were compared. RESULTS: Thirty-one patients (13.7%) were under 40 years, 26.9% (n = 61) were 40-49 years, 26.4% (n = 60) were 50-65 years and 33.0% (n = 75) were patients > 65 years. Compared with the other age groups, disease duration was significantly higher in subjects older than 65 years (p < 0.001). Only 8% of patients older than 65 years received corticosteroids compared with 29% of patients aged < 40 years, 13.1% of patients aged 40-49 years and 26.7% of patients aged 50-65 years (p = 0.007). Similarly, only 36% of patients over 65 years of age received a biological therapy compared with between 51.6 and 59% for the other age groups (p = 0.036). However, remission rates were not statistically different between groups. Disease-associated physical disability was similar among groups. Compared with patients aged < 40 years, more patients > 65 years achieved low disease impact (10.7% vs 37.7%, respectively; p < 0.05). CONCLUSIONS: Fewer older patients received corticosteroids and biological therapy. However, disease outcomes were similar or even better compared with those observed in younger patients. Therefore, treatment strategies for older patients with PsA should be similar to those offered to younger individuals.

Pyle's Disease: A human model of differentiated cortical and trabecular homeostasis. / Enfermedad de Pyle: un modelo humano de homeostasis corticotrabecular diferenciada.

Pyle's disease (OMIN number 265900) is a metaphyseal dysplasia of benign course, inherited with an autosomal recessive pattern. Some 30 genuine cases have been described so far. The cause of this process has been known since 2016, when its relationship to mutations in the gene encoding the sFRP protein, a known inhibitor of the Wnt pathway, was discovered. We report the case of a 58-year-old man, diagnosed with Pyle's disease based on his clinical and radiographic characteristics, whose phenotype suggested a differential control of cortical and trabecular bone homeostasis.

Abatacept in patients with rheumatoid arthritis and interstitial lung disease: A national multicenter study of 63 patients.

OBJECTIVE: Interstitial lung disease (ILD) is one of the most serious complications of rheumatoid arthritis (RA). In the present study, we aimed to assess the efficacy of abatacept (ABA) in patients with ILD associated to RA. METHODS: National multicenter, non-controlled, open-label registry study of RA patients with ILD treated with ABA. RESULTS: 63 patients (36 women) with RA-associated ILD undergoing ABA therapy were studied. The mean ± standard deviation age at the time of the study was 63.2 ± 9.8 years. The median duration of RA and ILD from diagnosis were 6.8 and 1 year, respectively. RA was seropositive in 55 patients (87.3%). In 15 (23.8%) of 63 patients the development of ILD was closely related to the administration of synthetic or biologic disease modifying anti-rheumatic drugs. After a follow-up of 9.4 ± 3.2 months, two-thirds of patients remained stable whereas one-quarter experienced improvement in the Modified Medical Research Council scale. At that time forced vital capacity remained stable in almost two-thirds of patents and improved in one out of five patients assessed. Also, diffusing capacity of the lung for carbon monoxide remained stable in almost two-thirds and showed improvement in a quarter of the patients assessed. At 12 months, 50% of the 22 patients in whom chest HRCT scan was performed due persistence of respiratory symptoms showed stabilization, 8 (36.4%) improvement and 3 worsening of the HRCT scan pattern. Eleven of 63 patients had to discontinue ABA, mainly due to adverse events. CONCLUSION: ABA appears to be an effective in RA-associated ILD.

Osteoimmunology: the study of the relationship between the immune system and bone tissue.

Bone tissue is a highly regulated structure, which plays an essential role in various physiological functions. Through autocrine and paracrine mechanisms, bone tissue is involved in hematopoiesis, influencing the fate of hematopoietic stem cells. There are a number of molecules shared by bone cells and immune system cells indicating that there are multiple connections between the immune system and bone tissue. In order to pool all the knowledge concerning both systems, a new discipline known under the term «osteoimmunology¼ has been developed. Their progress in recent years has been exponential and allowed us to connect and increase our knowledge in areas not seemingly related such as rheumatoid erosion, postmenopausal osteoporosis, bone metastases or periodontal disease. In this review, we have tried to summarize the most important advances that have occurred in the last decade, especially in those areas of interest related to rheumatology.

Dropped head syndrome in a patient with scleromyositis.

Dropped head syndrome (DHS) occurs in patients with severe weakness of the neck extensor muscles, of diverse origin, but most frequently because of neuromuscular diseases. Exceptionally, DHS may be the first manifestation of a systemic autoimmune disease. This report describes the case of a patient with DHS as a presenting sign of scleromyositis. We analyze the clinical features of the case and discuss the most important aspects of its pathogenesis and differential diagnosis.

Entheseal ultrasound abnormalities in patients with SAPHO syndrome.

This study was conducted to investigate the presence and characteristics of the ultrasound lesions that may be found in the entheses of patients with SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome. This cross-sectional study included 15 patients with SAPHO syndrome and 30 healthy controls matched for age, sex and body mass index. Subjects with regular sport activities as well as those with other rheumatic conditions were excluded from the study. Ultrasonography was used in both groups to study 14 entheses of the upper and lower extremities. Different elementary lesions representative of enthesis damage were defined. A total of 210 entheses in the study group and 420 in the control group were evaluated. Only one patient presented clinical enthesitis. In the study group, seven of the 15 patients (47%) showed morpho-structural entheseal alterations, versus only four of the 30 controls (13.3%; p < 0.001). The subjects with SAPHO showed ultrasound alterations in 32/210 entheses (15%), while the controls showed alterations in 20/420 entheses (4.8%), p < 0.001. The entheses with the largest number of morpho-structural alterations were those of the patellar and Achilles tendon. None of the controls showed power Doppler signal at enthesis or perienthesis level. Ultrasound evidence of enthesopathy seems to be a common feature in this series of patients with SAPHO syndrome.

[Mineral and bone disorders associated with chronic kidney disease]. / Trastorno mineral y óseo asociado a la enfermedad renal crónica.

Chronic renal failure (CRF) is frequent in patients with osteoporosis and the rheumatologist should be familiarized with basic diagnostic and treatment guidelines for bone mineral disease associated to this process. In patients with osteoporosis and stage I and II CRF, diagnosis and treatment does not vary from that in patients with normal RF. In stage III CRF, the focus will depend on the result of testing. In advanced stage CRF the approach should be coordinated with a nephrologist. In these cases it is possible to use antiresorptive agents although in well-selected and studied patients. The present review analyzes recent advances in this field with a focus on daily clinical practice.

[Adverse effects of bisphosphonates]. / Efectos adversos de los bisfosfonatos.

Aminobisphosphonates are drugs that have been used successfully in the treatment of osteoporosis for more than 20 years. Although main registry studies found a scarcity of relevant adverse events, in recent years and as a result of pharmacovigilance, different complications have been reported, some potentially serious. This has raised questions on the safety of these drugs, especially in high doses, like those used in oncology and long-term treatment, as needed in patients with osteoporosis. In this review, based on the analysis of relevant scientific evidence from clinical trials, case series, cohort studies and databases published to date, we summarize the clinical and epidemiological characteristics of the adverse effects of these drugs.

Rapid and sustained response to tocilizumab, anti-interleukin-6 receptor antibody, in a patient with nephrotic syndrome secondary to systemic juvenile idiopathic arthritis-related amyloidosis.

AA amyloidosis, or secondary amyloidosis, is a rare but serious complication of chronic inflammatory diseases. Chronic inflammatory arthritis is the commonest cause of AA amyloidosis and, when the latter appears, treatment can be frustrating. Deposition of fibrils, derived from circulating acute-phase reactant serum amyloid A protein (SAA), in the kidneys can lead to proteinuria and progressive loss of renal function. We describe the case of a 14-year-old female with systemic juvenile idiopathic arthritis who developed nephrotic syndrome secondary to AA amyloidosis; while she was unresponsive to all measures, including anti-tumour necrosis factor therapy, treatment with tocilizumab, an anti-human interleukin-6 receptor antibody, immediately normalized the SAA and reversed the nephrotic syndrome. We discuss this new therapeutic approach.

Prevalence of vertebral fracture in postmenopausal women with lumbar osteopenia using MorphoXpress® (OSTEOXPRESS Study).

BACKGROUND AND AIMS: Vertebral fracture (VF) is the most common complication of osteoporosis. However, more than half of all VF are asymptomatic and may go unnoticed, even in patients with osteoporosis. Our aim was to assess the prevalence of VF in postmenopausal women with osteopenic lumbar densitometry by means of vertebral morphometry, using the MorphoXpress® software. PATIENTS AND METHODS: This was an epidemiological, cross-sectional, multicenter study conducted among 289 postmenopausal women (>1 year of amenorrhoea), diagnosed with lumbar osteopenia (not due to chronic treatment with corticosteroids or immobilization). Vertebral deformities ≥20% were considered as VF. RESULTS: Demographic and clinical characteristics showed mean age (±SD) 64±9 years, body mass index 27±5 kg/m2, and time from diagnosis of 2±3 years. A total of 25% of subjects had a family history of osteoporotic fracture in first-degree relatives, and 23% had previous fragility fracture. The prevalence of VF was 50% (CI 95% 44-56), the most frequent being the dorsal wedge (34%). Previous fragility fracture was a risk factor for VF (OR 3.13, p=0.0004). A total of 76.5% of patients were receiving treatment, mainly calcium and vitamin D supplements (70%) and bisphosphonates (27%). CONCLUSIONS: MorphoXpress® revealed that 50% of postmenopausal women with osteopenic lumbar densitometry showed VF. This result is important since only 7% of all evaluated subjects had previously been diagnosed with VF.

Management pattern for patients with osteoarthritis treated with traditional non-steroidal anti-inflammatory drugs in Spain prior to introduction of Coxibs.

OBJECTIVE: To investigate the use of traditional non-steroidal anti-inflammatory drugs (tNSAIDs) in the management of osteoarthritis (OA) in primary care in Spain and to quantify patient and physician satisfaction with tNSAID therapy. METHODS: A 6-month retrospective, observational study conducted in 29 Spanish primary-care centres shortly before the first introduction of selective COX-2 inhibitors (Coxibs). RESULTS: A total of 897 patients with a mean age 66 +/- 9 years and radiologically documented OA were included: most (76%) were women. Three-quarters of the patients had primary generalised OA, with the knees (> 60% of cases) and lumbar spine (> 50% of cases) being the sites most commonly affected. Pain was an almost universal feature of the clinical presentation. More than 96% of patients had been prescribed tNSAIDs during the observation period, predominantly for pain relief. The most commonly prescribed agents were diclofenac, aceclofenac and piroxicam. Twenty-six per cent of discontinuations of tNSAIDs during the observation period were due to limited effectiveness of these drugs, making this the largest single cause of discontinuation apart from prescription expiry. Almost half of patients and physicians (46% in both categories) were not satisfied with OA treatment and only one patient in six regarded their overall health status during tNSAID therapy as satisfactory. Gastroprotective medications (GPMs) were prescribed for just over half the participating patients (51%), but use of these drugs appeared haphazard: 25% of those who received GPMs had no compelling indications for this therapy whereas more than half of the patients at high risk for gastrointestinal complications on the basis of clinical criteria were not receiving GPMs. CONCLUSIONS: There is a high level of dissatisfaction with tNSAID therapy of OA, arising in large part from a perception among many patients and physicians that these drugs are not always adequately effective in relieving the symptoms of this disease. These findings, together with the low patient perceptions of general health, indicate the need for new therapeutic approaches to OA.

Experience of rofecoxib in patients with osteoarthritis previously treated with traditional non-steroidal anti-inflammatory drugs in Spain: results of phase 2 of the VICOXX study.

OBJECTIVES: To compare patient and physician attitudes to osteoarthritis (OA) treatment with rofecoxib or traditional non-steroidal anti-inflammatory drugs (tNSAIDs). METHODS: A 6-month prospective study involving 562 OA patients enrolled at 29 Spanish primary-care centres. Patients were continued on established tNSAID therapy for the first 3 months then switched to rofecoxib 12.5 or 25 mg/day. RESULTS: Both patients and physicians were significantly more likely to be satisfied with rofecoxib treatment than with tNSAIDs (p < 0.001) and assessments of overall health status improved significantly during rofecoxib therapy (p < 0.001). Adherence to therapy was significantly better with rofecoxib than during tNSAID treatment (p < 0.001). Use of rofecoxib was associated with a significant reduction in the proportion of discontinuations attributed to lack of effectiveness (p < 0.001) or gastrointestinal (GI) adverse events (p < 0.001 compared with tNSAIDs). Rofecoxib was also associated with a > 60% reduction in the proportion of patients experiencing a GI adverse event and a halving in the proportion of patients who received GI co-medications; concomitant analgesic use decreased by one-third during rofecoxib therapy. CONCLUSIONS: Use of rofecoxib was associated with marked improvements in several indices of treatment effectiveness and tolerability, and in patient and physician satisfaction and perception of general health status compared with tNSAIDs. Rofecoxib is a valuable additional medication for relieving the symptoms of OA and its use in place of tNSAIDs may lead to a reduction in the prescription of concomitant medications.