Published in 2016

Originalsprog Dansk
Udgivelses sted Odense
Vol/bind 1
Udgave 1
Antal sider 100
Status Udgivet - 29 apr. 2016
Originalsprog Engelsk
Tidsskrift The British journal of nutrition
Vol/bind 116
Tidsskriftsnummer 2
Sider (fra-til) 377-9
Antal sider 3
ISSN 0007-1145
DOI
Status Udgivet - jul. 2016

BACKGROUND: The Osteoarthritis Research Society International (OARSI) has suggested to asses pain after specific activities consistently in clinical trials on knee OA. The Dynamic weight-bearing Assessment of Pain (DAP) assesses pain during activity (30 s of performing repeated deep knee-bends from a standing position). The purpose of this study is to evaluate the construct validity, responsiveness, and interpretability of the DAP for knee osteoarthritis (OA).

METHODS: One-hundred participants with knee OA were tested twice each with the DAP, the Knee injury and Osteoarthritis Outcome Score (KOOS), six-minute-walk-test (6MWT), and 6-min-walk-test with subsequent pain rating (6MWTpain), and once with a transition questionnaire (TRANS-Q) for the patient-reported change in pain after 12 weeks of exercise. Construct validity (baseline-scores) and responsiveness (change-scores) were estimated by Spearman Correlation Coefficients. We hypothesized that no correlations would be excellent (<0.7) (divergent validity), except for the 6MWTpain (convergent validity). The TRANS-Q was used for interpreting the DAP change-scores in terms of responsiveness and Minimal Important Change (MIC).

RESULTS: Divergent validity with the KOOS subscales (r = -0.31 to-0.45) and the 6MWT (r = -0.25) was supported. Convergent validity with the 6MWTpain was not supported (r = 0.54). The DAP change-scores corresponded to patient-reported change in pain (TRANS-Q), while correlations with change-scores on the other instruments were <0.35. The MIC was 2.4 DAP points.

CONCLUSIONS: The DAP possesses divergent validity compared to other instruments for knee OA, supporting the potential for this new way of assessing pain directly during activity. Importantly, the DAP change-scores correspond to patient-reported changes in pain, showing responsiveness. A change of 2.4 or more can be interpreted as clinically relevant. The DAP is a promising alternative to using 'pain on walking' as a clinical trial inclusion criterion/outcome.

Originalsprog Engelsk
Tidsskrift Health and Quality of Life Outcomes
Vol/bind 14
Sider (fra-til) 91
ISSN 1477-7525
DOI
Status Udgivet - 2016

Effectiveness and Feasibility Associated with Switching to a Second or Third TNF Inhibitor in Patients with Psoriatic Arthritis: A Cohort Study from Southern Sweden

Kristensen, L. E., Lie, E., Jacobsson, L. T. H., Christensen, R., Mease, P. J., Bliddal, H. & Geborek, P. jan. 2016 I : Journal of Rheumatology. 43, 1, s. 81-7 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: Because new modes of action for the treatment of psoriatic arthritis (PsA) are emerging, it is important to understand the use of switching to a second or third antitumor necrosis factor (anti-TNF) agent. This study investigated drug survival and treatment response rates of patients with PsA undergoing second- and third-line anti-TNF therapy.

METHODS: Patients with PsA were monitored in a prospective, observational study. Patients who switched anti-TNF therapy once (first-time switchers, n = 217) or twice (second-time switchers, n = 57) between January 2003 and March 2012 were studied. American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) good response at 3 and 6 months, as well as drug survival, were reported and further analyzed using the Cox and logistic regression models.

RESULTS: Median age for first-time switchers was 47 years and 42% were men. The corresponding values for second-time switchers were 48 years and 40% men. Three-month ACR20 Lund Efficacy Index (LUNDEX) response was achieved by 47% of first-time and 22% of second-time switchers; ACR50 LUNDEX rates were 21% and 14%, ACR70 LUNDEX rates were 12% and 2%, and EULAR good LUNDEX rates were 26% and 10%, respectively. Median drug survival time for patients switching anti-TNF for the first time was 64 months (95% CI 31-97) compared with 14 months (95% CI 5-23) for second-time switchers. Identified baseline predictor of ACR20 response to second-line treatment was the 28-joint Disease Activity Score values at baseline (OR 1.45, 95% CI 1.01-2.10), while higher Health Assessment Questionnaire scores predicted premature drug withdrawal (HR 1.60, 95% CI 1.03-2.48).

CONCLUSION: Response rates of first-time anti-TNF switchers are moderate, while the inferior response rates of second-time switchers suggest other therapeutic options should be considered in this situation.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 43
Tidsskriftsnummer 1
Sider (fra-til) 81-7
Antal sider 7
ISSN 0315-162X
DOI
Status Udgivet - jan. 2016

BACKGROUND: Prostate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may thus experience significant morbidity due to disease progression and treatment toxicity. In order to address some of these problems exercise has been suggested and previously studies have shown improvements of disease specific quality of life and a reduction in treatment-related toxicity. Cohort studies with long term follow up have suggested that physical activity is associated with improved survival in prostate cancer patients. Previously one randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of community-based football for men diagnosed with prostate cancer.

METHODS: Using a randomised controlled parallel group, multicenter, superiority trial design, two hundred prostate cancer patients will be recruited and randomised (1:1) to either community-based football one hour twice weekly or to a control group. The intervention period will be six months. The primary outcome is quality of life assessed after 12 weeks based on the change from baseline in the Functional Assessment of Cancer Therapy-Prostate questionnaire. Secondary outcomes are change from baseline to six months in quality of life, lean body mass, fat mass, whole body and regional bone markers, as well as physical activity and functional capacity at 12 weeks and six months. Safety outcome variables will be falls resulting in seeking medical assessment and fractures during the six-month period.

DISCUSSION: Football is viewed as a case for non-professional, supervised community-based team sport for promoting long-term physical activity in men diagnosed with prostate cancer. This randomised trial will provide data on effectiveness and safety for men with prostate cancer when football training is delivered in local football clubs.

TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02430792.

Originalsprog Engelsk
Artikelnummer 767
Tidsskrift B M C Cancer
Vol/bind 16
Tidsskriftsnummer 1
Antal sider 10
ISSN 1471-2407
DOI
Status Udgivet - 3 okt. 2016

Efficacy and safety of biological agents for systemic juvenile idiopathic arthritis: a systematic review and meta-analysis of randomized trials

Tarp, S., Amarilyo, G., Foeldvari, I., Christensen, R., Woo, J. M. P., Cohen, N., Pope, T. D. & Furst, D. E. apr. 2016 I : Rheumatology (Online). 55, 4, s. 669-79 11 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To define the optimal biologic agent for systemic JIA (sJIA) based on safety and efficacy data from a randomized controlled trial (RCT).

METHODS: Through a systematic literature search, sJIA RCTs evaluating biologic agents were identified. The primary efficacy outcome was defined as a 30% improvement according to the modified American College of Rheumatology Paediatric 30 response criteria (JIA ACR30). The primary safety outcome was defined as serious adverse events (SAEs). Outcomes were analysed by pairwise and network meta-analyses. The quality of evidence between biologic agents was assessed by applying the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology.

RESULTS: From the 493 citations originally identified, 5 RCTs were eligible for inclusion-one each for anakinra, canakinumab and tocilizumab and two for rilonacept: all vs placebo. While all were effective, the network meta-analysis indicated with low-quality evidence (due to indirect comparison and inconsistency) that rilonacept-treated patients were less likely to respond than those treated with canakinumab [odds ratio (OR) 0.10 (95% CI 0.02, 0.38), P = 0.001] or tocilizumab [OR 0.12 (95% CI 0.03, 0.44), P = 0.001]. Risks of SAEs were similar among the biologic agents (supported by very low-quality evidence) and not different from placebo.

CONCLUSION: Despite heterogeneous eligibility criteria and study designs across the five studies and different modified JIA ACR30 criteria, this meta-analysis of short-term RCTs presents empirical evidence that canakinumab and tocilizumab are more effective than rilonacept. Biologic agents in sJIA seem safe and comparable with respect to SAE risk in the short term.

Originalsprog Engelsk
Tidsskrift Rheumatology (Online)
Vol/bind 55
Tidsskriftsnummer 4
Sider (fra-til) 669-79
Antal sider 11
ISSN 1462-0332
DOI
Status Udgivet - apr. 2016

BACKGROUND: The development of EuroQol-5 dimensions (EQ-5D) utility over time in rheumatoid arthritis (RA) patients, treated with biologics other than tumour necrosis factor inhibitors (TNFi), based on the standard British (UK) and the new Swedish (SE) EQ-5D preference sets, has not been previously described.

METHODS: Demographics, core set data, EQ-5D utility, and treatment characteristics for patients with established RA, receiving biologics in southern Sweden from January 2006 to March 2014, were retrieved from observational databases. Theoretical, UK, and experience-based, SE, EQ-5D mean utilities were plotted over time.

RESULTS: Data regarding 2418 treatment courses with abatacept (ABA, n = 100), rituximab (RTX, n = 230), tocilizumab (TOC, n = 121), or TNFi (n = 1967) were included in the analysis. Patients starting TNFi treatment, as expected, had shorter disease duration and less previous biologics. Baseline utilities of patients commencing ABA and TOC, but not RTX, were also lower than in the TNFi group. Following treatment initiation, rapid utility improvements were seen with all therapies, reaching plateaus after approximately 1.5 months, and then remaining fairly stable throughout follow-up in patients adhering to therapy. SE utilities were consistently higher than UK, with baseline values at around 0.7 leaving little room for improvement.

CONCLUSIONS: ABA, RTX, TOC, and TNFi treatments were all associated with favourable EQ-5D utility developments in RA patients adhering to therapy. The compression of the experience-based SE preference set towards higher utilities may compromise its ability to detect between-group differences in quality-adjusted life-years, thus making cost-effectiveness harder to demonstrate in cost-utility analyses applying this preference set, rather than the standard UK.

Originalsprog Engelsk
Tidsskrift Arthritis Research & Therapy
Vol/bind 18
Sider (fra-til) 51
ISSN 1478-6354
DOI
Status Udgivet - 2016

Evaluation and validity of the Danish version of the Adult Strabismus Questionnaire AS-20

Ali, N., Sørensen, M. S., Sørensen, T. L. & Mortzos, P. 2016 I : Clinical Ophthalmology (Online). 10, s. 65-9 5 s.

Publikation: Forskning - peer reviewTidsskriftartikel

PURPOSE: Assessing health-related quality of life in patients with strabismus is important in evaluating the clinical benefits of strabismus treatment. The purpose of this study was to translate the Adult Strabismus Quality of Life Questionnaire (AS-20) into Danish and evaluate its reliability and validity in adult patients with strabismus in Denmark.

METHODS: The AS-20 was translated into Danish in accordance with standard international adopted methods. We presented the questionnaire to 64 adults with strabismus and to 13 non-strabismic adult controls. We tested the reliability of the Danish version by reassuring test-retest reliability, estimated the internal consistency, and analyzed the validity (discriminatory power) of the questionnaire by comparing patient scores with scores from control individuals.

RESULTS: The Danish AS-20 produced high level of internal consistency (Cronbach's α values) for both subscales (psychosocial: 0.95 and functional: 0.85). We found good discriminatory power of the AS-20. The patients scored significantly lower not only on AS-20 composite score (median =63, interquartile range [IQR] =44-79) compared to healthy individuals (median =98, IQR =93-100) (P<0.0001) but also on all individual questions in both subscales (psychosocial: 1-10 and functional: 11-20).

CONCLUSION: The Danish version of AS-20 shows high reliability and validity, and in our opinion, AS-20 is therefore a suitable instrument for evaluating self-perceived psychosocial and functional influence of strabismus.

Originalsprog Engelsk
Tidsskrift Clinical Ophthalmology (Online)
Vol/bind 10
Sider (fra-til) 65-9
Antal sider 5
ISSN 1177-5467
DOI
Status Udgivet - 2016

Evidence-Based Guideline: ACR made 10 strong treatment recommendations for RA, but high-quality evidence was sparse

Christensen, R. & Hart, L. E. 15 mar. 2016 I : Annals of internal medicine. 164, 6, s. JC27

Publikation: Forskning - peer reviewTidsskriftartikel

Originalsprog Engelsk
Tidsskrift Annals of internal medicine
Vol/bind 164
Tidsskriftsnummer 6
Sider (fra-til) JC27
ISSN 0003-4819
DOI
Status Udgivet - 15 mar. 2016

BACKGROUND: Subacromial pain syndrome (SAPS) accounts for around 50 % of all cases of shoulder pain. The most commonly used treatments are glucocorticosteroid (steroid) injections and exercise therapy; however, despite treatment SAPS patients often experience relapse of their symptoms. Therefore the clinical effect of combining steroid and exercise therapy is highly relevant to clarify. The aim of this randomized controlled trial was to investigate if exercise therapy added to steroid injection in patients with SAPS will improve the effect of the injection therapy on shoulder pain.

METHODS: In this two-arm randomized trial running over 26 weeks, patients with unilateral shoulder pain (> 4 weeks) and thickened subacromial bursa (> 2 mm on US) were included. At baseline all participants received two steroid injections into the painful shoulder with an interval of one week. Subsequently they were randomized (1:1) to either 10 weeks exercise of the involved shoulder (intervention group) or exercise of the uninvolved shoulder (control group). The patients were re-examined after the exercise program (at week 13) and again at week 26. The primary outcome assessed after 26 weeks was change in shoulder pain analyzed using the intention-to-treat principle (non-responder imputation).

RESULTS: Ninety-nine SAPS patients (58 female) participated (49 intervention/50 control). At both follow up visits (week 13 and 26) no statistically significant between-group differences in pain changes on a visual analog scale (mm) were seen (13 weeks: pain at rest 1.7 (95 % CI -3.6 to 7.0; P = 0.53); pain in activity 2.2 (95 % CI -6.5 to 10.9; P = 0.61), 26 weeks: rest 5.6 (95 % CI -0.9 to 12.1; P = 0.09); activity 2.2 (95 % CI -6.8 to 11.2; P = 0.62). The reduction in pain was most evident in the control group at all four pain measurements. The only difference between groups was seen by US examination at week 13, where fewer participants with impingement were observed in the intervention group compared with the controls (9 vs. 19 participants; P = 0.03).

CONCLUSION: Exercise therapy in the painful shoulder in SAPS patients did not improve the effectiveness of steroid injections for shoulder pain in patients with unilateral SAPS and enlarged subacromial bursa on US examination.

TRIAL REGISTRATION: ClinicalTrials.gov ( NCT01506804 ). Registration date 5 May 2011.

Originalsprog Engelsk
Tidsskrift Arthritis Research & Therapy
Vol/bind 18
Tidsskriftsnummer 1
Sider (fra-til) 129
ISSN 1478-6354
DOI
Status Udgivet - 2016

OBJECTIVE: The aim was to identify factors explaining inconsistent observations concerning the efficacy of intra-articular hyaluronic acid compared to intra-articular sham/control, or non-intervention control, in patients with symptomatic osteoarthritis, based on randomized clinical trials (RCTs).

METHODS: A systematic review and meta-regression analyses of available randomized trials were conducted. The outcome, pain, was assessed according to a pre-specified hierarchy of potentially available outcomes. Hedges׳s standardized mean difference [SMD (95% CI)] served as effect size. REstricted Maximum Likelihood (REML) mixed-effects models were used to combine study results, and heterogeneity was calculated and interpreted as Tau-squared and I-squared, respectively.

RESULTS: Overall, 99 studies (14,804 patients) met the inclusion criteria: Of these, only 71 studies (72%), including 85 comparisons (11,216 patients), had adequate data available for inclusion in the primary meta-analysis. Overall, compared with placebo, intra-articular hyaluronic acid reduced pain with an effect size of -0.39 [-0.47 to -0.31; P < 0.001], combining very heterogeneous trial findings (I(2) = 73%). The three most important covariates in reducing heterogeneity were overall risk of bias, blinding of personnel and trial size, reducing heterogeneity with 26%, 26%, and 25%, respectively (Interaction: P ≤ 0.001). Adjusting for publication/selective outcome reporting bias (by imputing "null effects") in 24 of the comparisons with no data available reduced the combined estimate to -0.30 [-0.36 to -0.23; P < 0.001] still in favor of hyaluronic acid.

CONCLUSION: Based on available trial data, intra-articular hyaluronic acid showed a better effect than intra-articular saline on pain reduction in osteoarthritis. Publication bias and the risk of selective outcome reporting suggest only small clinical effect compared to saline.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 46
Tidsskriftsnummer 1
Sider (fra-til) 34-48
Antal sider 15
ISSN 0049-0172
DOI
Status Udgivet - aug. 2016

BACKGROUND: We aimed to assess the association between exposure to sunshine during gestation and the risk of type 1 diabetes (T1D) in Danish children.

METHODS: The study population included 331,623 individuals born in Denmark from 1983 to 1988; 886 (0.26%) developed T1D by the age of 15 years. The values of sunshine hours were obtained from the Danish Meteorological Institute. Gestational exposure to sunshine was calculated by summing recorded monthly sunshine hours during the full 9 months prior to the month of birth. The linear variable then was split into two categories separated by the median value.

RESULTS AND CONCLUSIONS: Cox regression models showed that more sunshine during the third gestational trimester was associated with lower hazards (HR) of T1D at age 5-9 years in males: HR (95% CI): 0.60 (0.43-0.84), p=0.003. Our results should be considered in the context of evidence-based recommendations to the public about skin protection from the sun.

Originalsprog Engelsk
Tidsskrift Journal of pediatric endocrinology & metabolism : JPEM
Vol/bind 29
Tidsskriftsnummer 4
Sider (fra-til) 417-24
Antal sider 8
DOI
Status Udgivet - 1 apr. 2016

Hand bone loss in early rheumatoid arthritis during a methotrexate-based treat-to-target strategy with or without adalimumab-a substudy of the optimized treatment algorithm in early RA (OPERA) trial

Ørnbjerg, L. M., Østergaard, M., Jensen, T., Hørslev-Petersen, K., Stengaard-Pedersen, K., Junker, P., Ellingsen, T., Ahlquist, P., Lindegaard, H., Linauskas, A., Schlemmer, A., Dam, M. Y., Hansen, I., Lottenburger, T., Ammitzbøll, C. G., Jørgensen, A., Krintel, S. B., Raun, J., Hetland, M. L., Slot, O., Nielsen, L. K., Skjødt, H., Majgaard, O., Lorenzen, T., Horn, H. C., Kowalski, M., Johansen, I. L., Pedersen, P. M., Manilo, N., Bliddal, H. & OPERA Study Group 2016 I : Clinical rheumatology.

Publikation: Forskning - peer reviewTidsskriftartikel

This study aims to investigate 1-year hand bone loss (HBL1-year) in early rheumatoid arthritis (RA) patients treated with a methotrexate (MTX) and intra-articular triamcinolone treat-to-target strategy +/- adalimumab and to determine if HBL6months is associated with radiographic progression after 2 years. In a clinical trial (OPERA) of 180 treatment-naive early RA patients, bone mineral density (BMD) was estimated from hand radiographs with digital X-ray radiogrammetry (DXR) at baseline, after 6 (n = 90) and 12 months (n = 70) of follow-up. Baseline and 2-year radiographs were scored according to the Sharp/van der Heijde method. Baseline characteristics and HBL6months (0-6 months changes in DXR-BMD) were investigated as predictors of structural damage by univariate linear (∆ total Sharp/van der Heijde score (TSS) as dependent variable) and logistic (+/-radiographic progression (∆TSS >0) as dependent variable) regression analyses. Variables with p < 0.10 were included in multivariable models. In 70 patients with available HBL1-year data, HBL1-year was median (interquartile range (IQR)) -1.9 (-3.3; -0.26 mg/cm(2)) in the MTX + placebo group and -1.8 (-3.6; 0.06) mg/cm(2) in the MTX + adalimumab group, p = 0.98, Wilcoxon signed-rank. Increased HBL (compared to general population reference values) was found in 26/37 and 23/33 patients in the MTX + placebo and MTX + adalimumab groups, chi-squared = 0.99. In 90 patients with HBL6months data and 2-year radiographic data, HBL6months was independently associated with ∆TSS after 2 years (β = -0.086 (95% confidence interval = -0.15; -0.025) TSS unit/mg/cm(2) increase, p = 0.006) but not with presence of radiographic progression (∆TSS >0) (OR 0.96 (0.92-1.0), p = 0.10). In early RA patients treated with a methotrexate-based treat-to-target strategy, the majority of patients had increased HBL1-year, irrespective of adalimumab; HBL6months was independently associated with ∆TSS after 2 years.

Originalsprog Engelsk
Tidsskrift Clinical rheumatology
ISSN 0770-3198
DOI
Status E-pub ahead of print - 2016
Originalsprog Engelsk
Tidsskrift Sports Medicine
Vol/bind 46
Tidsskriftsnummer 2
Sider (fra-til) 293-294
ISSN 0112-1642
DOI
Status Udgivet - 2016

How widespread should pain be to be defined as widespread?

Amris, K., Wæhrens, E. E., Bliddal, H. & Danneskiold-Samsøe, B. aug. 2016 I : Pain. 157, 8, s. 1831-2 2 s.

Publikation: Forskning - peer reviewTidsskriftartikel

Originalsprog Engelsk
Tidsskrift Pain
Vol/bind 157
Tidsskriftsnummer 8
Sider (fra-til) 1831-2
Antal sider 2
ISSN 0304-3959
DOI
Status Udgivet - aug. 2016

Identification of prognostic factors for treatment response in rheumatoid arthritis

Christensen, A. W. 13 maj 2016 1 udg. København.

Publikation: ForskningPh.d.-afhandling

Originalsprog Dansk
Udgivelses sted København
Vol/bind 1
Udgave 1
Status Udgivet - 13 maj 2016

Identifying flares in rheumatoid arthritis: reliability and construct validation of the OMERACT RA Flare Core Domain Set

Bykerk, V. P., Bingham, C. O., Choy, E. H., Lin, D., Alten, R., Christensen, R., Furst, D. E., Hewlett, S., Leong, A., March, L., Woodworth, T., Boire, G., Haraoui, B., Hitchon, C., Jamal, S., Keystone, E. C., Pope, J., Tin, D., Thorne, J. C. & Bartlett, S. J. 2016 I : RMD Open. 2, 1, s. e000225

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To evaluate the reliability of concurrent flare identification using 3 methods (patient, rheumatologist and Disease Activity Score (DAS)28 criteria), and construct validity of candidate items representing the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA Flare Core Domain Set.

METHODS: Candidate flare questions and legacy measures were administered at consecutive visits to Canadian Early Arthritis Cohort (CATCH) patients between November 2011 and November 2014. The American College of Rheumatology (ACR) core set indicators were recorded. Concordance to identify flares was assessed using the agreement coefficient. Construct validity of flare questions was examined: convergent (Spearman's r); discriminant (mean differences between flaring/non-flaring patients); and consequential (proportions with prior treatment reductions and intended therapeutic change postflare).

RESULTS: The 849 patients were 75% female, 81% white, 42% were in remission/low disease activity (R/LDA), and 16-32% were flaring at the second visit. Agreement of flare status was low-strong (κ's 0.17-0.88) and inversely related to RA disease activity level. Flare domains correlated highly (r's≥0.70) with each other, patient global (r's≥0.66) and corresponding measures (r's 0.49-0.92); and moderately highly with MD and patient-reported joint counts (r's 0.29-0.62). When MD/patients agreed the patient was flaring, mean flare domain between-group differences were 2.1-3.0; 36% had treatment reductions prior to flare, with escalation planned in 61%.

CONCLUSIONS: Flares are common in rheumatoid arthritis (RA) and are often preceded by treatment reductions. Patient/MD/DAS agreement of flare status is highest in patients worsening from R/LDA. OMERACT RA flare questions can discriminate between patients with/without flare and have strong evidence of construct and consequential validity. Ongoing work will identify optimal scoring and cut points to identify RA flares.

Originalsprog Engelsk
Tidsskrift RMD Open
Vol/bind 2
Tidsskriftsnummer 1
Sider (fra-til) e000225
DOI
Status Udgivet - 2016

Impact of tobacco smoking on response to tumour necrosis factor-alpha inhibitor treatment in patients with ankylosing spondylitis: results from the Danish nationwide DANBIO registry

Glintborg, B., Højgaard, P., Lund Hetland, M., Steen Krogh, N., Kollerup, G., Jensen, J., Chrysidis, S., Jensen Hansen, I. M., Holland-Fischer, M., Højland Hansen, T., Nilsson, C., Espesen, J., Nordin, H., Rasmussen Loft, A. G., Pelck, R., Lorenzen, T., Flejsborg Oeftiger, S., Unger, B., Jaeger, F., Mosborg Petersen, P., Rasmussen, C. & Dreyer, L. 30 nov. 2016 I : Rheumatology (Online).

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: To investigate the association between tobacco smoking and disease activity, treatment adherence and treatment responses in patients with AS treated with their first tumour necrosis factor-alpha inhibitor (TNFi) therapy in routine care.

METHODS: Observational cohort study based on the Danish nationwide DANBIO registry. Kaplan-Meier plots, Cox and logistic regression analyses by smoking status (current/never/previous) were calculated for treatment adherence and BASDAI 50%/20 mm-response. Additional stratified analyses were performed for gender and TNFi-type.

RESULTS: Of 1576 AS patients included in the study, 1425(90%) had known smoking status (current/never/previous: 43%/41%/16%). The median follow-up time was 2.02 years (IQR 0.69-5.01). At baseline, current smokers compared with never smokers had longer disease duration (4 years (1-12)/2 years (0-10)), higher BASDAI (61 mm (47-73)/58 mm (44-70)), BASFI (53 mm (35-69)/46 mm (31-66)) and BASMI (40 mm (20-60)/30 mm (10-50)) scores (all P < 0.01). Current and previous smokers had shorter treatment adherence than never smokers (current: 2.30 years (1.81-2.79) (median (95% CI)); previous: 2.48 years (1.56-3.40), never: 4.12 years (3.29-4.95)), P < 0.0001). Similar results were found in multivariate analyses (current versus never smokers, HR 1.41 (95% CI 1.21-1.65), P < 0.001), most pronounced among men. Current smokers had poorer 6 months' BASDAI50%/20 mm-response rate than never smokers (42%/58%, P < 0.001). In multivariate analyses, current smokers had lower odds of achieving BASDAI50%/20 mm-response than never smokers, both overall (OR 0.48 (95% CI 0.35-0.65), P < 0.0001) and for the different TNFi-types (adalimumab 0.45 (0.27-0.76)/etanercept 0.24 (0.10-0.61)/infliximab 0.57 (0.34-0.95)).

CONCLUSION: In this study of TNFi-treated AS patients in clinical practice, current and previous smokers had significantly poorer patient-reported outcomes at baseline, shorter treatment adherence and poorer treatment response compared with never smokers.

Originalsprog Engelsk
Tidsskrift Rheumatology (Online)
ISSN 1462-0332
DOI
Status E-pub ahead of print - 30 nov. 2016

INTRODUCTION: Intensity of exercise is believed to be a key determinant of response to chronic obstructive pulmonary disease (COPD) rehabilitation. We hypothesized that a higher intensity of exercise, in combination with physiotherapist-led instructions and education in management of breathlessness, would lead to better self-management, possibly delaying calls to the emergency service and preventing hospitalization.

OBJECTIVE: We aimed to test this hypothesis in a subsequent randomized trial, and in order to test study processes and estimate hospitalization rates, we did a small preliminary prospective cohort study on severe COPD patients referred to outpatient rehabilitation.

METHODS: In 2013, four rehabilitation courses were scheduled (spring, summer, autumn, and winter) each lasting 8 weeks and including eight to ten patients. This preliminary study was designed as a controlled cohort study. The bi-weekly exercise sessions in the spring and autumn courses included a high-intensity walking exercise at 95% of estimated VO2 max for as long as possible. The other two rehabilitation courses included the usual walking exercise intensity (85% of estimated VO2 max). Hospitalization rates were assessed from the participants' medical records in an 18-month period.

RESULTS: We were able to enroll 31 patients in total (15 in the high-intensity exercise group and 16 in regular intensity). There were no group differences in the hospitalization rates. However, during review of the medical records, we observed a striking mortality rate among participants who had attended the high-intensity rehabilitation courses (five deaths) compared to the standard rehabilitation (zero deaths). Four of the five deaths were COPD exacerbations. Fisher's exact test was statistically significant (P=0.046), as was a log-rank test (P=0.019) of the Kaplan-Meier estimated survival rates.

CONCLUSION: These results from this small preliminary cohort study are alarming and raise concerns about the possible serious risks associated with high-intensity exercise rehabilitation of severe COPD patients.

Originalsprog Engelsk
Tidsskrift International journal of chronic obstructive pulmonary disease
Vol/bind 11
Sider (fra-til) 2329-2334
Antal sider 6
ISSN 1178-2005
DOI
Status Udgivet - 2016

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