Comparative Effectiveness and Persistence of SB4 and Reference Etanercept in Patients With Psoriatic Arthritis in Norway.

OBJECTIVE: We aim to compare drug effectiveness and persistence between the reference etanercept (ETN) and ETN biosimilar SB4 in patients with psoriatic arthritis (PsA) naive to ETN and to investigate drug effectiveness and persistence in those undergoing a mandatory nonmedical switch from ETN to SB4. METHODS: We used a retrospective comparative database study including 1,138 patients with PsA treated with ETN or SB4 (years 1999-2021) in Norway. Disease activity score in 28 joints (DAS28) and drug persistence were compared between unmatched ETN (n = 644) and SB4 (n = 252) cohorts and in matched analyses (n = 144, both cohorts) at baseline using a propensity score (PS) to adjust for confounders. Drug persistence was analyzed with the Kaplan-Meier method. RESULTS: In unmatched analyses, difference in change from baseline between ETN (n = 140) and SB4 (n = 132) for DAS28 at one year was mean 0.67 (95% confidence interval [CI] 0.38-0.96) in favor of ETN. In PS-matched analyses, the difference in change from baseline between ETN (n = 54) and SB4 (n = 54) was mean 0.09 (95% CI -0.33 to 0.50), and the mean difference assessed with an analysis of covariance model was 0.01 (95% CI -0.38 to 0.40), both within predefined equivalence margin (±0.6). Drug persistence at one year was mean 0.75 (95% CI 0.71-0.78) for ETN, mean 0.58 (95% CI 0.51-0.63) for SB4, hazard ratio (HR) 2.45 (95% CI 2.02-2.97) in unmatched analysis, and mean 0.55 (95% CI 0.46-0.63) for ETN, mean 0.60 (95% CI 0.51-0.67) for SB4, HR 1.29 (95%CI 0.94-1.76) in PS-matched cohorts. CONCLUSION: At one year, outcomes for PsA disease activity and drug persistence were comparable for patients treated with either ETN or SB4. In patients undergoing a mandatory nonmedical switch from ETN to SB4, drug effectiveness was maintained during a two-year period.

Male patients with inflammatory joint diseases are less likely than controls to be childless: results from a Norwegian population-based cohort study of 10 865 patients.

OBJECTIVES: To investigate the number of children per man and the proportion of childless men as a proxy of fertility in a national cohort of men with inflammatory joint diseases (IJDs), compared with matched controls from the general population. METHODS: This is a nationwide, population-based retrospective cohort study. Male patients with IJDs (n = 10 865) in the Norwegian Arthritis Registry were individually matched 1:5 on birth year and county of residence with men without IJDs obtained from the National Population Register (n = 54 325). Birth data were obtained from the Medical Birth Registry of Norway. We compared the mean number of children per man and the proportion of childless men and analysed the impact of age and year of diagnosis. RESULTS: The mean number of children per man in the patient group was 1.80 versus 1.69 in the comparison group (p <0.001), and 21% of the patients in the patient group were childless versus 27% in the comparison group (p <0.001). The finding of less childlessness and higher number of children per man remained consistent across age at diagnosis, except for those diagnosed at age 0-19 years. The difference in childlessness was most pronounced for men diagnosed after year 2000, especially when diagnosed at 30-39 years of age (22% vs 32%, p<0.001). CONCLUSION: In this large cohort study we found that patients with IJD have a higher number of children and are less likely to be childless compared with controls. Factors associated with developing or having an IJD might influence fertility and this requires further investigation.

Differential sensitivity of the 2020 revised comprehensive diagnostic criteria and the 2019 ACR/EULAR classification criteria across IgG4-related disease phenotypes: results from a Norwegian cohort.

BACKGROUND: We investigated sensitivity of the 2020 Revised Comprehensive Diagnostic Criteria (RCD) and the 2019 ACR/EULAR classification criteria across the four identified IgG4-related disease (IgG4-RD) phenotypes: "Pancreato-Hepato-Biliary", "Retroperitoneum and Aorta", "Head and Neck-limited" and "Mikulicz' and Systemic" in a well-characterized patient cohort. METHODS: We included adult patients diagnosed with IgG4-RD after comprehensive clinical assessment at Oslo University Hospital in Norway. We assigned patients to IgG4-RD phenotypes based on pattern of organ involvement and assessed fulfillment of RCD and 2019 ACR/EULAR classification criteria. Differences between phenotype groups were analyzed using one-way ANOVA for continuous variables, and contingency tables for categorical variables. RESULTS: The study cohort included 79 IgG4-RD patients assigned to the "Pancreato-Hepato-Biliary" (22.8%), Retroperitoneum and Aorta" (22.8%) "Head and Neck-limited" (29.1%), and "Mikulicz' and Systemic" (25.3%) phenotype groups, respectively. While 72/79 (91.1%) patients in total fulfilled the RCD, proportion differed across phenotype groups and was lowest in the "Retroperitoneum and Aorta" group (66.7%, p < 0.001). Among the 57 (72.2%) patients meeting the 2019 ACR/EULAR classification criteria, proportion was again lowest in the "Retroperitoneum and Aorta" group (27.8%, p < 0.001). CONCLUSION: The results from this study indicate that IgG4-RD patients having the "Retroperitoneum and Aorta" phenotype less often fulfill diagnostic criteria and classification criteria than patients with other IgG4-RD phenotypes. Accordingly, this phenotype is at risk of being systematically selected against in observational studies and randomized clinical trials, with potential implications for patients, caregivers and future definitions of IgG4-RD.

Exploring the impact of the national tender system on the use of costly drugs treating rheumatoid arthritis patients in ten rheumatology centers in Norway (2010-2019).

BACKGROUND: Biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) are highly effective in treating rheumatoid arthritis (RA), albeit high drug cost has restricted their use in many countries. As a countermeasure, Norway implemented pharmaceutical tendering as a cost-reducing strategy. The aim of this study was to assess the annual proportion of different b/tsDMARDs registered to treat RA patients under the influence of a Norwegian pharmaceutical tendering between 2010 and 2019. METHOD: The data is collected from ten Norwegian outpatient centers. The included patients are categorized as naïve, non-naïve, and current b/tsDMARD users. 13 individual b/tsDMARDs are assessed and compared with the tender rankings from each year. Overview of subcutaneous (sc) with per oral vs. intravenous (iv) and biosimilars vs. non-biosimilar are also described. RESULT: The tender-winning b/tsDMARD was the most or second most used drug in nine out of ten years for naïve users, seven for non-naïve users, and twice for current users. The average sum of the highest and second highest proportion among naïve, non-naïve, and current b/tsDMARD users were 75%, 53%, and 50% during the ten years, respectively. The tender-winning drug was iv in eight out of ten years. However, the average total proportion of sc and per oral b/tsDMARDs was about 70% for naïve b/tsDMARD users, 50% for non-naïve b/tsDMARD users, and 60% for current b/tsDMARD users. The main contributors to sc and per oral b/tsDMARD were etanercept (reference and biosimilar) and certolizumab pegol. The main contributors to iv b/tsDMARD were rituximab reference and infliximab biosimilar. Despite low-ranking offers, rituximab reference (offered as a second-line drug) often achieved a high proportion among non-naïve and current b/tsDMARD users. After the introduction of biosimilars, their average proportion was about 40%, 40%, and 20% for naïve, non-naïve, and current b/tsDMARD users, respectively. CONCLUSION: Based on observed data, a higher tender rank was associated with a higher proportion among naïve and non-naïve b/tsDMARD users. However, in most cases, sc b/tsDMARDs achieved a higher proportion with lower tender ranks than iv b/tsDMARDs with higher tender ranks.

Factors predicting death and cancer in patients with giant cell arteritis in Western Norway 1972-2012: a retrospective observational cohort study.

Objectives: Evidence as to whether or not giant cell arteritis (GCA) confers added risk of cancer or death is conflicting. Our aim was to identify factors predicting death or cancer in a large Norwegian GCA-cohort. Methods: This is a retrospective observational cohort study including patients diagnosed with GCA in Western Norway during 1972-2012. Patients were identified through computerized hospital records using the International Classification of Diseases coding. Medical records were reviewed and data about registered deaths and cancer occurrences were extracted from the Norwegian Cause of Death Registry and the Cancer Registry of Norway. We investigated predicting factors using Cox proportional hazards regression. Results: We identified 881 cases with a validated diagnosis of GCA (60% biopsy-verified). 490 patients (56%) died during the study period. Among 767 patients with no registered cancer prior to GCA diagnosis, 120 (16%) were diagnosed with cancer during the study period. Traditional risk factors were the main predictors of death; age at time of GCA-diagnosis [hazard ratio (HR) 2.81], smoking (HR 1.61), hypertension (HR 1.48) and previous cardiovascular disease (HR 1.26). Hemoglobin (Hb) level was also associated with risk of death with increasing Hb-levels at time of GCA-diagnosis indicating decreased risk of death (HR 0.91). Other GCA-related factors were not predictive of death. We did not identify any predictors of cancer risk. Conclusion: In our cohort of GCA-patients, the risk of death was predominantly predicted by age and traditional risk factors. We found no significant associations with regards to the risk of incident cancer.

Increased risk of periodontitis in patients with rheumatoid arthritis: A nationwide register study in Norway.

AIM: To investigate the risk of periodontitis in rheumatoid arthritis (RA) patients in a nationwide register-based study. MATERIALS AND METHODS: Patients and controls were defined using ICD-10 codes registered in the Norwegian Patient Registry (NPR), from 2011 to 2017. The 324,232 included subjects had at least one registered diagnostic code for RA (33,040 patients) or diagnostic codes for non-osteoporotic fractures or hip or knee replacement due to osteoarthritis (controls). The outcome was periodontitis, defined by codes for periodontal treatment from the Norwegian Control and Payment of Health Reimbursements Database (KUHR). Hazard ratios (HRs) were calculated for periodontitis in RA patients compared to controls. Generalized additive model in Cox regressions was estimated to visualize periodontitis occurrences as a function of number of RA visits. RESULTS: The risk of periodontitis increased with increasing number of RA visits. RA patients having 10 or more visits during the 7-year period had a 50% increased risk of periodontitis compared to controls (HR = 1.48, 95% confidence interval [CI]: 1.39-1.59); also, in patients with assumed new RA, an even higher risk estimate was seen (HR = 1.82, 95% CI: 1.53-2.17). CONCLUSIONS: In this register-based study in which periodontal treatment was used as a surrogate marker for periodontitis, we found an increased risk of periodontitis in RA patients, particularly those with active disease and new RA.

Exploring drug cost and disease outcome in rheumatoid arthritis patients treated with biologic and targeted synthetic DMARDs in Norway in 2010-2019 - a country with a national tender system for prescription of costly drugs.

BACKGROUND: In Norway, an annual tender system for the prescription of biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) has been used since 2007. This study aimed to explore annual b/tsDMARDs costs and disease outcomes in Norwegian rheumatoid arthritis (RA) patients between 2010 and 2019 under the influence of the tender system. METHODS: RA patients monitored in ordinary clinical practice were recruited from 10 Norwegian centers. Data files from each center for each year were collected to explore demographics, disease outcomes, and the prescribed treatment. The cost of b/tsDMARDs was calculated based on the drug price given in the annual tender process. RESULTS: The number of registered RA patients increased from 4909 in 2010 to 9335 in 2019. The percentage of patients receiving a b/tsDMARD was 39% in 2010 and 45% in 2019. The proportion of b/tsDMARDs treated patients achieving DAS28 remission increased from 42 to 67%. The estimated mean annual cost to treat a patient on b/tsDMARDs fell by 47%, from 13.1 thousand euros (EUR) in 2010 to 6.9 thousand EUR in 2019. The mean annual cost to treat b/tsDMARDs naïve patients was reduced by 75% (13.0 thousand EUR in 2010 and 3.2 thousand EUR in 2019). CONCLUSIONS: In the period 2010-2019, b/tsDMARD treatment costs for Norwegian RA patients were significantly reduced, whereas DAS28 remission rates increased. Our data may indicate that the health authorities' intention to reduce treatment costs by implementing a tender system has been successful.

Periodontitis in patients with systemic lupus erythematosus: A nationwide study of 1,990 patients.

BACKGROUND: The aim of this study was to examine the association between systemic lupus erythematosus (SLE) and periodontitis in Norway during a 10-year period from 2008 through 2017. METHODS: In this population-based study, 1,990 patients were included in the SLE-cohort based on diagnostic codes registered in the Norwegian Patient Registry. The control group (n = 170,332) comprised patients registered with diagnostic codes for non-osteoporotic fractures or hip or knee replacement because of osteoarthritis. The outcome was periodontitis, defined by procedure codes registered in the Control and Payment of Health Refunds database. Logistic regression analyses were performed to estimate odds ratio for periodontitis in patients versus controls adjusted for potential covariates. RESULTS: Periodontitis was significantly more common in SLE patients compared to controls (OR 1.78, 95% CI 1.47-2.14) and the difference was highest in SLE-patients 20 to 30 years of age (OR 3.24, 95% CI 1.23 - 8.52). The periodontitis rate in SLE patients was in the same range as for patients with diabetes mellitus type 2. CONCLUSIONS: Patients with SLE had an almost doubled risk of periodontitis compared with the control population, and the difference was most accentuated in the young patients. These findings warrant an increased focus on dental health in SLE-patients.

COVID-19 in patients with chronic inflammatory rheumatic joint disease. / Covid-19 hos pasienter med kronisk inflammatorisk leddsykdom.

BACKGROUND: Since patients with chronic inflammatory rheumatic joint diseases may be more prone to infections, we wished to investigate the incidence of COVID-19 in this group, and explore the possible significance of factors related to the rheumatic disease, the patient or the treatment. MATERIAL AND METHOD: Altogether 27 907 patients registered in the Norwegian Arthritis Registry (NorArthritis) were linked to the Norwegian Surveillance System for Communicable Diseases and the Norwegian Intensive Care and Pandemic Registry in order to find the incidence of COVID-19 in 2020, and the proportion of patients who were hospitalised. A standardised incidence ratio (SIR) was calculated by comparing with sex and age-specific incidence in the general population. Logistic regression analysis was used to investigate whether diagnosis, age, sex, disease activity, comorbidity or drug therapy had any bearing on the incidence. RESULTS: A total of 185 of the patients in NorArthritis tested positive for COVID-19, of whom 10 % were hospitalised. The incidence was lower than in the general population (SIR 0.84; 95 % confidence interval (CI): 0.72-0.97, P = 0.02). Young age and low disease activity were associated with higher incidence of infection. The other factors had no significant effect. INTERPRETATION: The fact that the incidence of COVID-19 was lower than in the general population, and that within the group it was lower in those with moderate/high disease activity and greater age, is most likely attributable to patients of advanced age with chronic active disease having protected themselves against infection to a greater degree.

Structured patient care pathway for gout. / Strukturert pasientforløp ved urinsyregikt.

BACKGROUND: Pharmacological treatment and follow-up of gout is often inadequate.The patients risk repeated, painful arthritis flares and some develop chronic tophaceous gout and joint damage. MATERIAL AND METHOD: Since 1 March 2017, a structured care pathway has been established for patients with gout at the Department of Rheumatology, Haukeland University Hospital. Patients were placed on preventive medication, the majority on allopurinol, and were regularly monitored. Patient education is key to the care pathway. The treatment goal is to lower the concentration of serum urate to a level below a defined threshold value (360 µmol/l for non-tophaceous gout or 300 µmol/l for tophaceous gout). Patient data were collected on a continuous basis and recorded in a research database. The care pathway is assessed after 18 months. RESULTS: A total of 103 patients have been included, of whom 93 (90 %) are men, with an average age of 63 years and large variations in duration of the disease (min.-max. 0-36 years). Eight patients left the care pathway during the project. The average level of serum urate at inclusion was 446 µmol/l (min.-max. 144-751 µmol/l). The average maximum dose of allopurinol was 333 mg (min.-max. 100-700 mg). Survival analysis showed that three months after the start of urate-lowering therapy, 49 % of the patients had achieved their analytical treatment goal. Altogether 83 % achieved the goal within six months. The majority (70 %) were free of flares after achieving the treatment goal. INTERPRETATION: A standardised care pathway for gout enables adaptation of preventive treatment through regular monitoring. The care pathway helps the vast majority of patients to achieve treatment goals, which is crucial to avoid arthritis flares.

Risk of Cancer in 767 Patients with Giant Cell Arteritis in Western Norway: A Retrospective Cohort with Matched Controls.

OBJECTIVE: To determine the risk of cancer in a large Norwegian cohort of patients with giant cell arteritis (GCA). METHODS: This is a hospital-based, retrospective, observational cohort study including patients diagnosed with GCA in the Bergen Health Area during 1972-2012. Patients were identified through computerized hospital records using the International Classification of Diseases coding system. Medical records were reviewed. Each patient was randomly assigned population controls matched on age, sex, and geography from the Central Population Registry of Norway. Data on the occurrence of cancer were obtained from the Cancer Registry of Norway. The cumulative risk of malignancy was estimated using Kaplan-Meier methods and potential differences were analyzed using the Gehan-Breslow and log-rank tests. RESULTS: We identified 881 cases with a clinical diagnosis of GCA, of which 792 fulfilled the American College of Rheumatology (ACR) 1990 classification criteria and 528 were biopsy-verified. Cases with no registered cancer prior to GCA diagnosis were included in a time-to-event analysis, with first cancer as the event (n = 767 with clinical GCA diagnosis, 686 fulfilling ACR criteria for GCA, 463 biopsy-verified). These cases were matched with previously cancer-free population controls (n = 1437, 1284, 895, respectively). We found no significant difference in the risk of malignancy after time of diagnosis/matching for GCA patients compared to population controls (p > 0.05). CONCLUSION: In this study of a large and well-characterized cohort of patients with GCA, there was no difference in the risk of malignancy in patients with GCA compared to matched population controls.

Guideline recommended treatment to targets of cardiovascular risk is inadequate in patients with inflammatory joint diseases.

OBJECTIVES: Patients with inflammatory joint diseases (IJD) have an increased risk of cardiovascular disease (CVD). Our goal was to examine indications for, and use of, lipid-lowering therapy (LLT) and antihypertensive treatment (AntiHT) in patients with IJD. Furthermore, to investigate the frequency of low-density lipoprotein cholesterol (LDL-c) and blood pressure (BP) goal attainment among IJD patients. METHODS: The cohort was derived from the NOrwegian Collaboration on Atherosclerosis in patients with Rheumatic joint diseases (NOCAR). Indications for AntiHT were: systolic/diastolic BP ≥ 140/90 mm Hg, self-reported hypertension or AntiHT. CVD risk was estimated by the systematic coronary risk evaluation (SCORE) algorithm. LDL-c goals were <2.6 mmol/L in case of diabetes, total cholesterol > 8 mmol/L or a SCORE estimate ≥ 5%, and <1.8 mmol/L for those with established CVD or SCORE ≥ 10%. Comparisons across IJD entities were performed using age and sex adjusted logistic regression. RESULTS: In total, 2277 patients (rheumatoid arthritis: 1376, axial spondyloarthritis: 474, psoriatic arthritis: 427) were included. LLT and AntiHT were indicated in 36.1% and 52.6% of the patients, of whom 37.6% and 47.0% were untreated, respectively. LDL-c and BP targets were obtained in 26.2% and 26.3%, respectively. Guideline recommended treatment and/or corresponding treatment targets were not initiated or obtained in approximately 50%. Rheumatoid arthritis patients were particularly likely to be undertreated with LLT, whereas hypertension undertreatment was most common in psoriatic arthritis. CONCLUSIONS: Inadequate CVD prevention encompasses all the three major IJD entities. The unmet need for CVD preventive measures is not only prevalent in RA, but exists across all the major IJD entities.

Incidence and Predictive Factors for Orthopedic Surgery in Patients with Psoriatic Arthritis.

OBJECTIVE: To investigate the incidence of orthopedic procedures in patients with psoriatic arthritis (PsA), and how patient characteristics, time of diagnosis, and treatment affect the need for surgery. METHODS: We reviewed the medical history of 1432 patients with possible PsA at Haukeland University Hospital in Bergen, Norway. There were 590 patients (mean age 49 yrs, 52% women) who had sufficient journal information and a confirmed diagnosis of PsA, and who were included in the present study. Relevant orthopedic procedures were obtained from the hospital's administrative patient records. Survival analyses were completed to evaluate the effect of different factors such as year of diagnosis, age, sex, radiographic changes, disease activity, and treatment, on the risk of surgery. RESULTS: There were 171 procedures (25% synovectomies, 15% arthrodesis, and 53% prostheses) performed on 117 patients. These factors all increased the risk of surgery: female sex [relative risk (RR) 1.9, p = 0.001], age ≥ 70 years at diagnosis (RR 2.4, p = 0.001), arthritis in initial radiographs (RR 2.2, p = 0.006), and maximum erythrocyte sedimentation rate 30-59 mm/h (RR 1.6, p = 0.026). Time period of diagnosis had no effect on the outcome. In a subanalysis of surgery exclusive of hip and knee arthroplasty, diagnosis in earlier years (1954-1985 vs 1999-2011) was a risk factor (RR 2.1, p = 0.042). Antirheumatic treatment changed significantly over time. CONCLUSION: There were 20% of patients with PsA who needed surgery. We found that the prognosis of patients with PsA did not change regarding the risk of orthopedic surgery, despite the change in treatment. A possible explanation is the increase in large joint replacements in the general population.

The role of anti-citrullinated protein antibody reactivities in an inception cohort of patients with rheumatoid arthritis receiving treat-to-target therapy.

BACKGROUND: Anti-citrullinated protein antibody (ACPA) reactivities precede clinical onset of rheumatoid arthritis (RA), and it has been suggested that ACPA reactivities towards distinct target proteins may be associated with differences in RA phenotypes. We aimed to assess the prevalence of baseline ACPA reactivities in an inception cohort of patients with early RA, and to investigate their associations with disease activity, treatment response, ultrasound findings and radiographic damage. METHODS: Disease-modifying antirheumatic drug (DMARD)-naïve patients with early RA, classified according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria, were included in the ARCTIC trial and assessed in the present analysis. During follow up, patients were monitored frequently and treatment was adjusted according to a predetermined protocol, starting with methotrexate monotherapy with prednisolone bridging. Analysis of 16 different ACPA reactivities targeting citrullinated peptides from fibrinogen, alpha-1 enolase, vimentin, filaggrin and histone was performed using a multiplex chip-based assay. Samples from 0, 3, 12 and 24 months were analysed. Controls were blood donors with similar characteristics to the patients (age, gender, smoking status). RESULTS: A total of 217 patients and 94 controls were included. Median [25, 75 percentile] number of ACPA reactivities in all patients was 9 [4, 12], and were most prevalent in anti-cyclic citrullinated peptide /rheumatoid factor-positive patients 10 [7, 12]. Disease activity measures and ultrasound scores at baseline were lower in ACPA reactivity-positive compared to ACPA reactivity-negative patients. ACPA reactivity levels decreased after 3 months of DMARD treatment, most pronounced for fibrinogenß 60-74 to 62% of baseline antibody level, with least change in filaggrin 307-324 to 81% of baseline antibody level, both p < 0.001. However, outcomes in disease activity measures, ultrasound and radiographic scores after 12 and 24 months were not associated with baseline levels or changes in ACPA reactivity levels and/or seroreversion after 3 months. CONCLUSIONS: The clinical relevance of analysing ACPA reactivities in intensively treated and closely monitored early RA was limited, with no apparent associations with disease activity, prediction of treatment response or radiographic progression. Further studies in larger patient materials are needed to understand the role of ACPA reactivities in patients with RA classified according to the 2010 ACR/EULAR criteria and treated according to modern treatment strategies. TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT01205854 . Registered on 21 September 2010.

Calprotectin as a marker of inflammation in patients with early rheumatoid arthritis.

OBJECTIVES: Calprotectin is an inflammatory marker of interest in rheumatoid arthritis (RA). We evaluated whether the level of calprotectin was associated with disease activity, and if it was predictive of treatment response and radiographic progression in patients with early RA. METHODS: Plasma from disease-modifying antirheumatic drug (DMARD)-naïve patients with RA fulfilling 2010 American College of Rheumatology/European League Against Rheumatism classification criteria with symptom duration <2 years was analysed for calprotectin at baseline, and after 1, 3 and 12 months. All patients received treat-to-target therapy, as part of a randomised controlled strategy trial (ARCTIC). The association between calprotectin, erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) and measures of disease activity were assessed by correlations. We used likelihood ratios and logistic regression models to assess the predictive value of the baseline inflammatory markers for treatment response and radiographic damage. RESULTS: 215 patients were included: 61% female, 82% anti-citrullinated peptide antibody positive, mean (SD) age 50.9 (13.7) years and median (25, 75 percentile) symptom duration 5.8 (2.8, 10.5) months. Calprotectin was significantly correlated with Clinical Disease Activity Index (r=0.32), ESR (r=0.50) and ultrasonography power Doppler (r=0.42) before treatment onset. After 12 months of treatment, calprotectin, but not ESR and CRP, was significantly correlated with power Doppler (r=0.27). Baseline levels of calprotectin, ESR and CRP were not predictive of treatment response, but high levels of calprotectin were associated with radiographic progression in multivariate models. CONCLUSIONS: Calprotectin was correlated with inflammation assessed by ultrasound before and during DMARD treatment, and was also associated with radiographic progression. The data support that calprotectin may be of interest as an inflammatory marker when assessing disease activity in different stages of RA. TRIAL REGISTRATION NUMBER: NCT01205854; Post-results.

Hip replacement surgery in patients with ankylosing spondylitis.

OBJECTIVES: Although TNF-α inhibitors' striking effect on clinical symptoms have revolutionised the treatment of ankylosing spondylitis (AS), no certain influence on the development of spinal ankylosis and joint destruction has been documented. We wished to investigate whether improved treatment has affected the use of hip arthroplasty surgery. METHODS: Using the Norwegian Arthroplasty Register, we selected hip prosthesis procedures performed in patients with AS in 1988-2010 (n=534), and compared the trend in the number of procedures being performed annually in 1988-2002 versus 2003-2010. Patients with osteoarthritis (OA) (n=95094) were used as a control group. RESULTS: The frequency of hip prosthesis surgery increased significantly in both groups up until 2002. In 2003-2010, although not statistically significant (p=0.087), there was a trend towards a reduced frequency in the AS group when compared with the expected continued increase as was seen among patients with OA. Mean age at surgery increased significantly (p<0.001) from 49.9 years to 56.4 years when comparing patients with AS up until and after 2002. CONCLUSIONS: TNF-α inhibitors were introduced to patients with AS in Norway in 2000-2003, and our findings suggest that they may have altered the prognosis by inhibiting or slowing large joint arthritis and thus reducing the need for hip replacement surgery.

Long-term prognosis after operation for adhesive small bowel obstruction.

AIM OF STUDY: The objective of this study was to determine the pattern of recurrence after one or more episodes of adhesive small bowel obstruction (ASBO) during a follow-up period of up to 40 years. Furthermore, we wanted to analyze possible factors with an influence on the recurrence rate and to study the magnitude of "everyday" abdominal pain among these patients. PATIENTS AND METHODS: Hospital records of 500 patients operated on for adhesive obstruction at Haukeland University Hospital from 1961 to 1995 were studied. The patients were followed until death, loss to follow-up, or end of study (February 2002), with a median follow-up of 10 years and a maximum follow-up time of 40 years. A questionnaire was sent to all living patients to obtain information on recurrences and abdominal complaints. RESULTS: The cumulative recurrence rate for patients operated once for ASBO was 18% after 10 years and 29% at 30 years. For patients admitted several times for ASBO, the relative risk of recurrent ASBO increased with increasing number of prior ASBO episodes. The cumulative recurrence rate reached 81% for patients with 4 or more ASBO admissions. Other factors influencing the recurrence rate were the method of treatment of the last previous ASBO episode (conservative versus surgical) and the number of abdominal operations prior to the initial ASBO operation. Compared to results from the general populations, more ASBO patients suffer from abdominal pain at home. Women and patients having matted adhesions have significantly more complaints about abdominal pain than men and patients with band adhesions. CONCLUSION: The risk of recurrence increased with increasing number of ASBO episodes. Most recurrent ASBO episodes occur within 5 years after the previous one, but a considerable risk is still present 10 to 20 years after an ASBO episode. Surgical treatment decreased the risk of future admissions for ASBO, but the risk of new surgically treated ASBO episodes was the same regardless of the method of treatment. People treated for ASBO seem to be more prone to experiencing abdominal pain than the normal population, especially those having matted adhesions.