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author:("kviem, T K")
1.  High incidence of vertebral and non-vertebral fractures in the OSTRA cohort study: a 5-year follow-up study in postmenopausal women with rheumatoid arthritis 
Osteoporosis International  2011;22(9):2413-2419.
Summary
A 5-year follow-up study was performed in female RA patients with established disease looking at vertebral fractures, scored on spinal X-rays, and non-vertebral fractures. We found a high incidence rate of vertebral and non-vertebral fractures in these patients compared to population-based studies.
Introduction
The aim of this study is to investigate the incidence of vertebral and non-vertebral fractures over a 5-year period in a cohort of postmenopausal patients with established rheumatoid arthritis (RA).
Methods
One hundred and fifty female patients with established RA were included into the OSTRA cohort. The cohort was assessed at baseline and at 5 years for incident vertebral and non-vertebral fractures. Spinal X-rays were taken at baseline and at follow-up and scored using the semi-quantitative method according to Genant.
Results
At 5 years, 102 patients (68%) were examined and included in the present analysis. At baseline, the mean age was 61 years, disease duration 17 years, body mass index 25.5 kg/m2 and 65% of the patients were rheumatoid factor positive. Fifteen percent were treated with bisphosphonates, 25% received calcium supplementation and 20% vitamin-D supplementation at baseline. During the 5-year follow-up, a total of 16 patients out of 102 patients (16%) had a new non-vertebral fracture [annual incidence of 3.2 (95% CI 1.8–5.5) per 100 patients/year]. In 18 patients out of 97 patients (19%), new vertebral fractures were identified on spinal X-ray [annual incidence of 3.7 (95% C.I. 2.2–5.8) per 100 patients/year].
Conclusions
We found a high incidence of vertebral and non-vertebral fractures in a cohort of women with established RA compared to population-based studies.
doi:10.1007/s00198-010-1517-6
PMCID: PMC3150654  PMID: 21229234
Female; Fractures; Osteoporosis; Rheumatoid arthritis; Vertebral fractures
2.  Bone mineral density in patients with hand osteoarthritis compared to population controls and patients with rheumatoid arthritis 
Annals of the Rheumatic Diseases  2007;66(12):1594-1598.
Objectives
Several studies have revealed increased bone mineral density (BMD) in patients with knee or hip osteoarthritis, but few studies have addressed this issue in hand osteoarthritis (HOA). The aims of this study were to compare BMD levels and frequency of osteoporosis between female patients with HOA, rheumatoid arthritis (RA) and controls aged 50–70 years, and to explore possible relationships between BMD and disease characteristics in patients with HOA.
Methods
190 HOA and 194 RA patients were recruited from the respective disease registers in Oslo, and 122 controls were selected from the population register of Oslo. All participants underwent BMD measurements of femoral neck, total hip and lumbar spine (dual‐energy x ray absorptiometry), interview, clinical joint examination and completed self‐reported questionnaires.
Results
Age‐, weight‐ and height‐adjusted BMD values were significantly higher in HOA versus RA and controls, the latter only significant for femoral neck and lumbar spine. The frequency of osteoporosis was not significantly different between HOA and controls, but significantly lower in HOA versus RA. Adjusted BMD values did not differ between HOA patients with and without knee OA, and significant associations between BMD levels and symptom duration or disease measures were not observed.
Conclusion
HOA patients have a higher BMD than population‐based controls, and this seems not to be limited to patients with involvement of larger joints. The lack of correlation between BMD and disease duration or severity does not support the hypothesis that higher BMD is a consequence of the disease itself.
doi:10.1136/ard.2006.068940
PMCID: PMC2095305  PMID: 17502356
3.  Perception of Improvement in Patients With Rheumatoid Arthritis Varies With Disease Activity Levels at Baseline 
Arthritis and rheumatism  2009;61(3):313-320.
Objective
To analyze the minimum clinically important improvement (MCII) of disease activity measures in rheumatoid arthritis (RA) using patient-derived anchors, and to assess whether criteria for improvement differ with baseline disease activity.
Methods
We used data from a Norwegian observational database comprising 1,050 patients (73% women, 65% rheumatoid factor-positive, mean duration of RA 7.7 years). At 3 months after initiation of therapy, patients indicated whether their condition had improved, had considerably improved, was unchanged, had worsened, or had considerably worsened. We used receiver operating characteristic curve analysis to determine the MCII for the Disease Activity Score based on the assessment of 28 joints (DAS28), the Simplified Disease Activity Index (SDAI), and the Clinical Disease Activity Index (CDAI), and analyzed the effects of different levels of baseline disease activity on the MCII.
Results
On average, patients started with high disease activity and improved significantly during treatment (American College of Rheumatology 20%, 50%, and 70% improvement criteria responses were 37%, 17%, and 5%, respectively). The overall mean (95% confidence interval [95% CI]) thresholds for MCII after 3 months for the DAS28, SDAI, and CDAI were 1.20 (95% CI 1.18–1.22), 10.95 (95% CI 10.69–11.20), and 10.76 (95% CI 10.49–11.04), respectively, and the mean (95% CI) thresholds for major responses were 1.82 (95% CI 1.80–1.83), 15.82 (95% CI 15.65–16.00), and 15.00 (95% CI 14.82–15.18), respectively. With increasing disease activity, much higher changes in disease activity were needed to achieve MCII according to patient judgment.
Conclusion
The perception of improvement of disease activity of patients with RA is considerably different depending on the disease activity level at which they start.
doi:10.1002/art.24282
PMCID: PMC2957836  PMID: 19248136
4.  The comparative effectiveness of anti‐TNF therapy and methotrexate in patients with psoriatic arthritis: 6 month results from a longitudinal, observational, multicentre study 
Annals of the Rheumatic Diseases  2007;66(8):1038-1042.
Objectives
To compare the response to treatment with tumour necrosis factor (TNF) inhibitors and methotrexate (MTX) monotherapy in patients with psoriatic arthritis (PsA) within a real‐life clinical setting.
Methods
We analysed data from an ongoing longitudinal, observational multicentre study in Norway. Our data comprised 526 cases of patients with PsA who received either anti‐TNF treatment (n = 146) or MTX monotherapy (n = 380) and were followed for at least 6 months with measures of disease activity, health status and utility scores. A propensity score was computed to adjust for channelling bias. The changes in measures of disease activity and health‐related quality of life from baseline to 3‐ and 6‐month follow‐up were compared between the groups with adjustments for the baseline value of the dependent variable and the propensity score (analyses of covariance (ANCOVA)).
Results
The groups were significantly different at baseline with respect to demographic and disease activity measures. The variables included in the propensity score were age, sex, number of previous disease modifying anti‐rheumatic drugs (DMARDs), presence of erosive disease, treatment centre and investigator's global assessment. The adjusted changes at 6 months were significantly larger in the anti‐TNF group for ESR, DAS‐28, M‐HAQ, patient's assessments of pain, fatigue and global disease activity on a visual analogue scale (VAS) and 4 out of 8 SF‐36 dimensions.
Conclusions
Clinical improvement was superior with TNF inhibitors compared to MTX monotherapy in patients with PsA, when assessed in this setting of daily clinical practice.
doi:10.1136/ard.2006.064808
PMCID: PMC1954690  PMID: 17213251
5.  Consensus statement on the use of rituximab in patients with rheumatoid arthritis 
Annals of the Rheumatic Diseases  2006;66(2):143-150.
A large number of experts experienced in the treatment of rheumatoid arthritis were involved in formulating a consensus statement on the use of B cell‐targeted treatment with rituximab in patients with rheumatoid arthritis. The statement was supported by data from randomised controlled clinical trials and the substantial literature on oncology. The statement underwent three rounds of discussions until its ultimate formulation. It should guide clinicians in the use of this newly approved biological agent in treating patients with rheumatoid arthritis.
doi:10.1136/ard.2006.061002
PMCID: PMC1798500  PMID: 17068064
6.  A good year for European rheumatology 
doi:10.1136/ard.2006.066654
PMCID: PMC1798400  PMID: 17178756
7.  Controlling the obesity epidemic is important for maintaining musculoskeletal health 
Annals of the Rheumatic Diseases  2006;65(11):1401-1402.
Obesity: the risks on musculoskeletal health
doi:10.1136/ard.2006.058172
PMCID: PMC1798351  PMID: 17038450
8.  Evaluation of bone mineral density, bone metabolism, osteoprotegerin and receptor activator of the NFκB ligand serum levels during treatment with infliximab in patients with rheumatoid arthritis 
Annals of the Rheumatic Diseases  2006;65(11):1495-1499.
Objectives
To examine whether treatment with anti‐tumour necrosis factor (TNF) α prevents loss of bone mineral density (BMD) at the spine and hip (generalised) and in the hands (local) of patients with rheumatoid arthritis, and to study the changes in markers of bone metabolism, including receptor activator of the NFκB ligand (RANKL) and osteoprotegerin (OPG), during anti‐TNF treatment.
Patients and methods
102 patients with active rheumatoid arthritis, who were treated with infliximab during 1 year, were included in this open cohort study. The BMD of the spine and hip (dual x ray absorptiometry ) and hands dual x ray radiogrammetry was measured before the start of treatment and after 1 year. Changes in osteocalcin formation, β‐isomerised carboxy terminal telopeptide of type 1 collagen (β‐CTx, resorption), RANKL and OPG were determined at 0, 14, 30 and 46 weeks.
Results
The BMD of the spine and hip was unchanged during treatment with infliximab, whereas BMD of the hand decreased significantly by 0.8% (p<0.01). The BMD of the hip in patients with a good European League Against Rheumatism response showed a favourable change compared with patients not achieving such a response. Serum β‐CTx and RANKL were both considerably decreased compared with baseline at all time points. The decrease in β‐CTx was associated with the decrease in Disease Activity Score of 28 joints and C reactive protein during the 0–14 weeks interval.
Conclusion
In patients with rheumatoid arthritis treated with infliximab, spine and hip bone loss is arrested, whereas metacarpal cortical hand bone loss is not stopped. The outcome of the study also supports a relationship between clinical response, in terms of reduced inflammatory activity, and changes in bone loss of the spine, hip and hands.
doi:10.1136/ard.2005.044198
PMCID: PMC1798341  PMID: 16606653
9.  Adalimumab and methotrexate is more effective than adalimumab alone in patients with established rheumatoid arthritis: results from a 6‐month longitudinal, observational, multicentre study 
Annals of the Rheumatic Diseases  2006;65(10):1379-1383.
Objectives
To compare the effectiveness of adalimumab monotherapy and adalimumab and methotrexate (MTX) combination therapy in patients with established rheumatoid arthritis.
Methods
Data from an ongoing longitudinal observational study in Norway were used to compare response to treatment with two different adalimumab regimens (monotherapy, n = 84; combination with MTX, n = 99). Patients were assessed with measures of disease activity, health status and utility scores. Within‐group changes were analysed from baseline to follow‐up at 3 and 6 months and the changes were compared between groups after adjustment for the propensity score. The groups were also compared for the proportions of patients achieving European League Against Rheumatism (EULAR) good response, Disease Activity Score (DAS)28 remission and treatment terminations.
Results
The improvement from baseline was significant for all measures in the adalimumab and MTX group, but only for DAS28, joint counts, two Short‐form Health Survey with 36 questions (SF‐36) dimensions and patient's and investigator's global assessment in the monotherapy group. All between‐group differences were numerically in favour of combination therapy and significant for C reactive protein, joint counts, DAS28, Modified Health Assessment Questionnaire, investigator's global assessment, four SF‐36 dimensions and Short Form 6D at 6 months. More patients in the combination therapy group reached EULAR good response (p<0.001) and remission (p = 0.07). At 6 months, 80.8% of the patients in the combination therapy group and 59.5% in the monotherapy group remained on treatment (p = 0.002). More withdrawals in the monotherapy group were due to adverse events.
Conclusions
Our results were consistent across several categories of end points and suggest that adalimumab combined with MTX is effective in patients with rheumatoid arthritis treated in daily clinical practice and is superior to adalimumab monotherapy.
doi:10.1136/ard.2006.051540
PMCID: PMC1798316  PMID: 16679432
10.  Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double‐blind comparison 
Annals of the Rheumatic Diseases  2006;65(10):1357-1362.
Objective
To compare the efficacy and safety of etanercept and sulfasalazine, alone and in combination, in patients with active rheumatoid arthritis despite sulfasalazine treatment.
Methods
A double‐blind, randomised study in adult patients with active rheumatoid arthritis despite stable sulfasalazine (2–3 g/day) treatment. The primary end point was a 20% response by the American College of Rheumatology (ACR) criteria at 24 weeks.
Results
At baseline, the three treatment groups (sulfasalazine, n = 50; etanercept, n = 103; etanercept and sulfasalazine, n = 101) were comparable for demographic variables and disease activity. Lack of efficacy was the primary reason for discontinuation (sulfasalazine, n = 12; etanercept, n = 1; etanercept and sulfasalazine, n = 4; p<0.001). Significantly more patients receiving etanercept, alone or in combination (74% for each), achieved ACR 20 responses at 24 weeks than those receiving sulfasalazine (28%; p<0.01). Similarly, more patients in the etanercept groups achieved ACR 50 and ACR 70 responses than those in the sulfasalazine group (p<0.01). In the groups receiving etanercept, significant differences in the ACR core components were observed by week 2 compared with those receiving sulfasalazine alone (p<0.01). The incidences of several common adverse events (headache, nausea, asthenia) were lower with etanercept alone than with the combination (p<0.05), but infections and injection site reactions were higher with etanercept alone (p<0.05). The safety profiles of both etanercept treatment groups were comparable with previous experience of etanercept.
Conclusions
For all efficacy variables assessed, etanercept alone or in combination with sulfasalazine resulted in substantial and similar improvement in disease activity from baseline to week 24 compared with sulfasalazine alone in patients with active rheumatoid arthritis despite their sulfasalazine treatment. All three treatments were generally well tolerated.
doi:10.1136/ard.2005.049650
PMCID: PMC1798315  PMID: 16606651
11.  ASAS/EULAR recommendations for the management of ankylosing spondylitis 
Annals of the Rheumatic Diseases  2005;65(4):442-452.
Objective
To develop evidence based recommendations for the management of ankylosing spondylitis (AS) as a combined effort of the ‘ASsessment in AS' international working group and the European League Against Rheumatism.
Methods
Each of the 22 participants was asked to contribute up to 15 propositions describing key clinical aspects of AS management. A Delphi process was used to select 10 final propositions. A systematic literature search was then performed to obtain scientific evidence for each proposition. Outcome data for efficacy, adverse effects, and cost effectiveness were abstracted. The effect size, relative risk, number needed to treat, and incremental cost effectiveness ratio were calculated. On the basis of the search results, 10 major recommendations for the management of AS were constructed. The strength of recommendation was assessed based on the strength of the literature evidence, risk‐benefit trade‐off, and clinical expertise.
Results
The final recommendations considered the use of non‐steroidal anti‐inflammatory drugs (NSAIDs) (conventional NSAIDs, coxibs, and co‐prescription of gastroprotective agents), disease modifying antirheumatic drugs, treatments with biological agents, simple analgesics, local and systemic steroids, non‐pharmacological treatment (including education, exercise, and physiotherapy), and surgical interventions. Three general recommendations were also included. Research evidence (categories I–IV) supported 11 interventions in the treatment of AS. Strength of recommendation varied, depending on the category of evidence and expert opinion.
Conclusion
Ten key recommendations for the treatment of AS were developed and assessed using a combination of research based evidence and expert consensus. Regular updating will be carried out to keep abreast of new developments in the management of AS.
doi:10.1136/ard.2005.041137
PMCID: PMC1798102  PMID: 16126791
ankylosing spondylitis; management; recommendations; evidence based medicine; spondyloarthropathies; ASAS; EULAR
12.  EULAR expects further development in 2006 
Many people contribute to the progress of EULAR
PMCID: PMC1797967  PMID: 16344490
13.  Dissemination and evaluation of the ASAS/EULAR recommendations for the management of ankylosing spondylitis: results of a study among 1507 rheumatologists 
Annals of the Rheumatic Diseases  2008;67(6):782-788.
Background:
Ten ASAS/EULAR recommendations for the management of ankylosing spondylitis (AS) were published in 2006.
Objectives:
(a) To disseminate and (b) to evaluate conceptual agreement with, and (c) application of, these recommendations as well as (d) potential barriers to the application.
Methods:
A questionnaire was sent to rheumatologists in 10 countries. It included (a) the text of the recommendations; (b) rheumatologists’ demographic variables; (c) two numerical rating scales from 1 to 10 for each recommendation: conceptual agreement with, and application of, the recommendation (10 indicates maximal agreement and maximal application); and (d) a list of potential barriers to the application of the recommendation. Statistical analysis included descriptive and multivariate analyses.
Results:
7206 questionnaires were sent out; 1507 (21%) were returned. Of the 1507 answering rheumatologists, 62% were men, mean (SD) age 49 (9) years, and 34% had an academic position. Conceptual agreement with the recommendations was high (mean (SD) for all recommendations 8.9 (0.9)). Self-reported application was also high (8.2 (1.0)). The difference between agreement and application varied across recommendations and countries. The most pronounced discrepancies were reported for use of anti-tumour necrosis factor drugs in a few countries, with funding as the most commonly reported barrier for application of this recommendation.
Conclusion:
This large project has helped the dissemination of the ASAS/EULAR recommendations for the management of AS and shows that conceptual agreement with the recommendations is very high. The project also highlights inequalities in access to healthcare for European citizens with AS.
doi:10.1136/ard.2007.080077
PMCID: PMC2565578  PMID: 18055468
14.  Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative 
Annals of the Rheumatic Diseases  2008;68(7):1086-1093.
Objectives:
To develop evidence-based recommendations for the use of methotrexate in daily clinical practice in rheumatic disorders.
Methods:
751 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2007–8 consisting of three separate rounds of discussions and Delphi votes. Ten clinical questions concerning the use of methotrexate in rheumatic disorders were formulated. A systematic literature search in Medline, Embase, Cochrane Library and 2005–7 American College of Rheumatology/European League Against Rheumatism meeting abstracts was conducted. Selected articles were systematically reviewed and the evidence was appraised according to the Oxford levels of evidence. Each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed.
Results:
A total of 16 979 references was identified, of which 304 articles were included in the systematic reviews. Ten multinational key recommendations on the use of methotrexate were formulated. Nine recommendations were specific for rheumatoid arthritis (RA), including the work-up before initiating methotrexate, optimal dosage and route, use of folic acid, monitoring, management of hepatotoxicity, long-term safety, mono versus combination therapy and management in the perioperative period and before/during pregnancy. One recommendation concerned methotrexate as a steroid-sparing agent in other rheumatic diseases.
Conclusions:
Ten recommendations for the use of methotrexate in daily clinical practice focussed on RA were developed, which are evidence based and supported by a large panel of rheumatologists, enhancing their validity and practical use.
doi:10.1136/ard.2008.094474
PMCID: PMC2689523  PMID: 19033291
15.  Impact of adalimumab on work participation in rheumatoid arthritis: comparison of an open-label extension study and a registry-based control group 
Annals of the Rheumatic Diseases  2008;68(6):930-937.
Background and objectives:
Rheumatoid arthritis (RA) causes considerable disability and often results in loss of work capacity and productivity. This study evaluated the impact of adalimumab, a tumour necrosis factor antagonist with demonstrated efficacy in RA, on long-term employment.
Methods:
Data from an open-label extension study (DE033) of 486 RA patients receiving adalimumab monotherapy who previously did not respond to at least one disease-modifying antirheumatic drug (DMARD) and had baseline work status information were compared with data from 747 RA patients receiving DMARD treatment in a Norway-based longitudinal registry. Primary outcomes included the time patients continued working at least part time and the likelihood of stopping work. Secondary outcomes included American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) responses and disease remission. Outcomes were compared 6, 12 and 24 months after enrolment.
Results:
During a 24-month period, the 158 patients who received adalimumab and were working at baseline worked 7.32 months longer (95% CI 4.8 to 9.1) than did the 180 patients treated with DMARDs, controlling for differences in baseline characteristics. Regardless of baseline work status, patients receiving adalimumab worked 2.0 months longer (95% CI 1.3 to 2.6) and were significantly less likely to stop working than those receiving DMARDs (HR 0.36 (95% CI −0.30 to 0.42) for all patients and 0.36 (95% CI 0.15 to 0.85) for patients working at baseline, respectively). The patients who received adalimumab were also considerably more likely to achieve ACR responses and disease remission than DMARD-treated patients. Patients who achieved EULAR good response and remission were less likely to stop working, but this relationship was only seen in patients receiving DMARDs.
Conclusions:
Patients with RA who received adalimumab experienced considerably longer periods of work and continuous employment, and greater rates of clinical responses, than patients receiving DMARDs. The mechanism by which adalimumab decreases likelihood of stopping work seems to be different from that of DMARD treatment and independent of clinical responses.
doi:10.1136/ard.2008.092734
PMCID: PMC2674552  PMID: 18829616
16.  Adalimumab therapy reduces hand bone loss in early rheumatoid arthritis: explorative analyses from the PREMIER study 
Annals of the Rheumatic Diseases  2008;68(7):1171-1176.
Objective:
The effect of adalimumab on hand osteoporosis was examined and related to radiographic joint damage in the three treatment arms of the PREMIER study: adalimumab plus methotrexate, adalimumab and methotrexate monotherapy. Predictors of hand bone loss were also searched for.
Methods:
768 patients (537 fulfilled 2 years) with rheumatoid arthritis (RA) for less than 3 years, never treated with methotrexate, were included. Hand bone loss was assessed by digital x ray radiogrammetry (DXR) on the same hand radiographs scored with modified Sharp score at baseline, 26, 52 and 104 weeks. For DXR, metacarpal cortical index (MCI) was the primary bone measure.
Results:
At all time points the rate of percentage DXR–MCI loss was lowest in the combination group (−1.15; −2.16; −3.03) and greatest in the methotrexate monotherapy group (−1.42; −2.87; −4.62), with figures in between for the adalimumab monotherapy group (−1.33; −2.45; −4.03). Significant differences between the combination group and the methotrexate group were seen at 52 (p = 0.009) and 104 weeks (p<0.001). The order of hand bone loss across the three treatment arms was similar to the order of radiographic progression. Older age, elevated C-reactive protein and non-use of adalimumab were predictors of hand bone loss.
Conclusion:
This study supports a similar pathogenic mechanism for hand bone loss and erosions in RA. The combination of adalimumab and methotrexate seems to arrest hand bone loss less effectively than radiographic joint damage. Quantitative measures of osteoporosis may thus be a more sensitive tool for assessment of inflammatory bone involvement in RA.
doi:10.1136/ard.2008.091264
PMCID: PMC2689520  PMID: 18801760
17.  Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study 
Annals of the Rheumatic Diseases  2008;68(7):1146-1152.
Objective:
To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy.
Methods:
Patients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2–3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO).
Results:
Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n  =  103), etanercept plus sulfasalazine (n  =  101) and sulfasalazine (n  =  50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p<0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p<0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p<0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p<0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p<0.01).
Conclusion:
Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.
doi:10.1136/ard.2007.087106
PMCID: PMC2689524  PMID: 18794178
18.  Efficacy and safety of a novel synergistic drug candidate, CRx-102, in hand osteoarthritis 
Annals of the Rheumatic Diseases  2007;67(7):942-948.
Objective:
The novel synergistic drug candidate CRx-102 comprises dipyridamole and low dose prednisolone and is in clinical development for the treatment of immunoinflammatory diseases. The purpose of this clinical study was to examine the efficacy and safety of CRx-102 in patients with hand osteoarthritis (HOA).
Methods:
The study was conducted as a blinded, randomised, placebo-controlled trial at four centres in Norway. Eligibility criteria included being of age 30–70 years, at least one swollen and tender joint, a Kellgren–Lawrence (K–L) score of 2 or higher on radiographs, and a score of at least 30 mm pain on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) visual analogue pain scale (VAS). The primary endpoint was a reduction in pain from baseline to day 42 on the AUSCAN pain subscale. Two-sided p values for the differences in least squares (LS) means adjusted for baseline are presented.
Results:
The mean age of the 83 patients with HOA was 60 years and 93% were females. CRx-102 was statistically superior to placebo at 42 days for changes in AUSCAN pain (LS mean −14.2 vs −4.0) and for clinically relevant secondary endpoints (joint pain VAS (−18.6 vs −6.3), patient global VAS (−15.9 vs −4.2)) in the intention to treat population. The most frequently reported adverse event during the study was headache (52% in CRx-102 vs 15% in the placebo group).
Conclusions:
The novel synergistic drug candidate CRx-102 demonstrated efficacy by statistically reducing pain compared to placebo in HOA and was generally well tolerated.
doi:10.1136/ard.2007.074401
PMCID: PMC2564788  PMID: 17962237
19.  Sicca symptoms, saliva and tear production, and disease variables in 636 patients with rheumatoid arthritis 
Annals of the Rheumatic Diseases  1999;58(7):415-422.
OBJECTIVES—(1) To estimate the prevalence of ocular and oral sicca symptoms (SISY) or reduced saliva and tear production; (2) to relate SISY and sicca signs to measures of disease activity, damage, and health status; and (3) to examine the relation between symptoms and objective signs of tear and saliva production in a large sample of representative patients with rheumatoid arthritis (RA).
METHODS—From an unselective county RA register 636 patients (age 20-70 years) were examined with Schirmer-I test (ST), unstimulated whole saliva (UWS), questions on SISY and measures of disease activity, damage and health status.
RESULTS—Ocular sicca symptoms were reported in 38%, oral sicca symptoms in 50%, and a combination of both in 27%. Reduced tear production was present in 29%, and reduced saliva production in 17%. The minimum frequency of secondary Sjögren's syndrome was 7%. Measurements of exocrine disease manifestations were to variable extents bivariately correlated to disease activity measures, physical disability, pain, fatigue, and use of xerogenic drugs, but were not related to deformed joint count. Multivariate analyses revealed significant associations between disease activity and reduced saliva production. Only weak associations between SISY and tear or saliva production were observed.
CONCLUSION—SISY, reduced tear and saliva production were frequent extra-articular manifestations in RA, but were only weakly intercorrelated. High disease activity and at least two SISY were independent predictors of reduced saliva production, but ocular and oral dryness did not seem to be closely related to disease duration, disease activity, damage or health status.


PMCID: PMC1752918  PMID: 10381485
20.  Natural killer (NK) cell activity of peripheral blood, synovial fluid, and synovial tissue lymphocytes from patients with rheumatoid arthritis and juvenile rheumatoid arthritis. 
Annals of the Rheumatic Diseases  1982;41(5):490-494.
Natural killer (NK) cell activity was investigated in peripheral blood, synovial fluid, and synovial tissue lymphocytes from patients with rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA). Unfractionated lymphocytes, T lymphocytes, and non-T lymphocytes from the 3 compartments of JRA patients had reduced activity compared with that of normal peripheral blood lymphocytes (with p values usually between 0.05 and 0.1). Unfractionated synovial tissue lymphocytes of RA patients also showed reduced cytotoxicity (0.05 less than p less than 0.1), whereas peripheral blood lymphocytes exerted normal NK cell activity. The NK activity was exerted by cells both with and without Fc gamma receptors. The highest cytotoxicity was observed in Fc gamma receptor-positive cells, both in peripheral blood and synovial fluid, since more than 70% reduction in NK activity was found after depletion of Fc gamma receptor-positive cells. No evidence of lymphocytotoxic antibodies or other factors with influence on NK cells was observed in the patients' sera.
PMCID: PMC1001029  PMID: 6181746
21.  Treating axial and peripheral spondyloarthritis, including psoriatic arthritis, to target: results of a systematic literature search to support an international treat-to-target recommendation in spondyloarthritis 
Annals of the Rheumatic Diseases  2013;73(1):238-242.
Background
Current recommendations for the management of axial spondyloarthritis (SpA) and psoriatic arthritis are to monitor disease activity and adjust therapy accordingly. However, treatment targets and timeframes of change have not been defined. An international expert panel has been convened to develop ‘treat-to-target’ recommendations, based on published evidence and expert opinion.
Objective
To review evidence on targeted treatment for axial and peripheral SpA, as well as for psoriatic skin disease.
Methods
We performed a systematic literature search covering Medline, Embase and Cochrane, conference abstracts and studies in http://www.clinicaltrials.gov.
Results
Randomised comparisons of targeted versus routine treatment are lacking. Some studies implemented treatment targets before escalating therapy: in ankylosing spondylitis, most trials used a decrease in Bath Ankylosing Spondylitis Disease Activity Index; in psoriatic arthritis, protocols primarily considered a reduction in swollen and tender joints; in psoriasis, the Modified Psoriasis Severity Score and the Psoriasis Area and Severity Index were used. Complementary evidence correlating these factors with function and radiographic damage at follow-up is sparse and equivocal.
Conclusions
There is a need for randomised trials that investigate the value of treat-to-target recommendations in SpA and psoriasis. Several trials have used thresholds of disease activity measures to guide treatment decisions. However, evidence on the effect of these data on long-term outcome is scarce. The search data informed the expert committee regarding the formulation of recommendations and a research agenda.
doi:10.1136/annrheumdis-2013-203860
PMCID: PMC3888585  PMID: 23740234
Spondyloarthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Treatment

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