Analysis of clinical outcomes according to original treatment groups 16years after the pivotal IFNB-1b trial

2011 ◽  
Vol 2011 ◽  
pp. 95
Author(s):  
A. Minagar
Keyword(s):  
Clinical Outcomes ◽  
Treatment Groups ◽  
Original Treatment

scholarly journals Analysis of clinical outcomes according to original treatment groups 16 years after the pivotal IFNB-1b trial

2010 ◽  
Vol 81 (8) ◽  
pp. 907-912 ◽  
Author(s):  
G. C. Ebers ◽  
A. Traboulsee ◽  
D. Li ◽  
D. Langdon ◽  
A. T. Reder ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Treatment Groups ◽  
Original Treatment

scholarly journals The effects of surgical treatment and sclerotherapy for intramuscular venous malformations: a comparative clinical study

2021 ◽  
Vol 48 (6) ◽  
pp. 622-629
Author(s):  
Yun Hyun Kim ◽  
Jeong Yeop Ryu ◽  
Joon Seok Lee ◽  
Seok Jong Lee ◽  
Jong Min Lee ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Treatment Group ◽  
Clinical Outcomes ◽  
Vascular Malformations ◽  
Medical Center ◽  
Surgical Excision ◽  
Complication Rates ◽  
Venous Malformations ◽  
Treatment Groups ◽  
Comparative Clinical Study

Background Venous malformations (VMs) are the most common type of vascular malformations. Intramuscular venous malformations (IMVMs) are lesions involving the muscles, excluding intramuscular hemangiomas. The purpose of this study was to compare clinical outcomes between patients with IMVMs who were treated with sclerotherapy and those who were treated with surgical excision.Methods Of 492 patients with VMs treated between July 2011 and August 2020 at a single medical center for vascular anomalies, 63 patients diagnosed with IMVM were retrospectively reviewed. Pain, movement limitations, swelling, and quality of life (QOL) were evaluated subjectively, while radiological outcomes were assessed by qualified radiologists at the center. Complication rates were also evaluated, and radiological and clinical examinations were used to determine which treatment group (sclerotherapy or surgical excision) exhibited greater improvement.Results Although there were no significant differences in pain (P=0.471), swelling (P=0.322), or the occurrence of complications (P=0.206) between the two treatment groups, the surgical treatment group exhibited significantly better outcomes with regard to movement limitations (P=0.010), QOL (P=0.013), and radiological outcomes (P=0.017). Moreover, both duplex ultrasonography and magnetic resonance imaging showed greater improvements in clinical outcomes in the surgical excision group than in the sclerotherapy group.Conclusions Although several studies have examined IMVM treatment methods, no clear guidelines for treatment selection have been developed. Based on the results of this study, surgical excision is strongly encouraged for the treatment of IMVMs.

scholarly journals 575. Evaluation of Risk Factors and Clinical Outcomes of Patients with Vancomycin-Resistant Enterococcus Infections

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S271-S271
Author(s):  
Gauri Chauhan ◽  
Nikunj M Vyas ◽  
Todd P Levin ◽  
Sungwook Kim
Keyword(s):  
Risk Factors ◽  
Hospital Mortality ◽  
Clinical Outcomes ◽  
Subgroup Analysis ◽  
Term Care ◽  
Treatment Groups ◽  
Increased Risk ◽  
History Of ◽  
Vancomycin Resistant ◽  
The Impact

Abstract Background Vancomycin-resistant Enterococci (VRE) occurs with enhanced frequency in hospitalized patients and are usually associated with poor clinical outcomes. The purpose of this study was to evaluate the risk factors and clinical outcomes of patients with VRE infections. Methods This study was an IRB-approved multi-center retrospective chart review conducted at a three-hospital health system between August 2016-November 2018. Inclusion criteria were patients ≥18 years and admitted for ≥24 hours with cultures positive for VRE. Patients pregnant or colonized with VRE were excluded. The primary endpoint was to analyze the association of potential risk factors with all-cause in-hospital mortality (ACM) and 30-day readmission. The subgroup analysis focused on the association of risk factors with VRE bacteremia. The secondary endpoint was to evaluate the impact of different treatment groups of high dose daptomycin (HDD) (≥10 mg/kg/day) vs. low dose daptomycin (LDD) (< 10 mg/kg/day) vs. linezolid (LZD) on ACM and 30-day readmission. Subgroup analysis focused on the difference of length of stay (LOS), length of therapy (LOT), duration of bacteremia (DOB) and clinical success (CS) between the treatment groups. Results There were 81 patients included for analysis; overall mortality was observed at 16%. Utilizing multivariate logistic regression analyses, patients presenting from long-term care facilities (LTCF) were found to have increased risk for mortality (OR 4.125, 95% CI 1.149–14.814). No specific risk factors were associated with 30-day readmission. Patients with previous exposure to fluoroquinolones (FQ) and cephalosporins (CPS), nosocomial exposure and history of heart failure (HF) showed association with VRE bacteremia. ACM was similar between HDD vs. LDD vs. LZD (16.7% vs. 15.4% vs. 0%, P = 0.52). No differences were seen between LOS, LOT, CS, and DOB between the groups. Conclusion Admission from LTCFs was a risk factor associated with in-hospital mortality in VRE patients. Individuals with history of FQ, CPS and nosocomial exposure as well as history of HF showed increased risk of acquiring VRE bacteremia. There was no difference in ACM, LOS, LOT, and DOB between HDD, LDD and LZD. Disclosures All authors: No reported disclosures.

Comparative Clinical Outcomes After Intra-articular Injection With Adipose-Derived Cultured Stem Cells or Noncultured Stromal Vascular Fraction for the Treatment of Knee Osteoarthritis

2019 ◽  
Vol 47 (11) ◽  
pp. 2577-2583 ◽  
Author(s):  
Naomasa Yokota ◽  
Mari Hattori ◽  
Tadahiko Ohtsuru ◽  
Masaki Otsuji ◽  
Stephen Lyman ◽  
...  
Keyword(s):  
Stem Cells ◽  
Clinical Outcomes ◽  
Repeated Measures ◽  
Stromal Vascular Fraction ◽  
Research Society ◽  
Level Of Evidence ◽  
Treatment Groups ◽  
Knee Oa ◽  
Standard Medical Therapy ◽  
Osteoarthritis Research Society

Background: Intra-articular injection of adipose-derived stem cells (ASCs) has shown promise for improving symptoms and cartilage quality in the treatment of osteoarthritis (OA). However, while most preclinical studies have been performed with plastic-adherent ASCs, most clinical trials are being conducted with the stromal vascular fraction (SVF), prepared from adipose tissue without prior culture. Purpose: To directly compare clinical outcomes of intra-articular injection with ASCs or SVF in patients with knee OA. Study Design: Cohort study; Level of evidence, 3. Methods: The authors retrospectively compared 6-month outcomes in 42 patients (59 knees) receiving intra-articular injection with 12.75 million ASCs and 38 patients (69 knees) receiving a 5-mL preparation of SVF. All patients had Kellgren-Lawrence grade 2, 3, or 4 knee OA and had failed standard medical therapy. The visual analog scale (VAS) pain score and Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline and 1, 3, and 6 months after injection were considered as outcomes. Outcome Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) criteria were also used to assess positive response. A repeated measures analysis of variance was used for comparison between the treatment groups. Results: No major complications occurred in either group. The SVF group had a higher frequency of knee effusion (SVF 8%, ASC 2%) and minor complications related to the fat harvest site (SVF 34%, ASC 5%). Both groups reported improvements in pain VAS and KOOS domains. Specifically, in the ASC group, symptoms improved earlier (by 3 months; P < .05) and pain VAS decreased to a greater degree (55%; P < .05) compared with the SVF group (44%). The proportion of OMERACT-OARSI responders in the ASC group was slightly higher (ASCs, 61%; SVF, 55%; P = .25). Conclusion: It was observed that both ASCs and SVF resulted in clinical improvement in patients with knee OA, but that ASCs outperform SVF in the early reduction of symptoms and pain with less comorbidity.

scholarly journals Comparision Between Clopidogrel and Prasugrel On hs-CRP Levels Post Percutaneous Intervention

2017 ◽  
Vol 02 (01) ◽  
pp. 030-035
Author(s):  
A. Kumar ◽  
Indrani Garre
Keyword(s):  
Clinical Outcomes ◽  
Inflammatory Marker ◽  
Vascular Complications ◽  
Composite Endpoint ◽  
High Sensitivity ◽  
Bleeding Risk ◽  
Percutaneous Intervention ◽  
Treatment Groups ◽  
Significant Difference ◽  
Hs Crp

AbstractAims: This study investigated the effect of clopidogrel versus prasugrel treatment on inflammatory activity as evidenced by high-sensitivity C-reactive protein (hs-CRP) levels among patients who underwent percutaneous intervention (PCI). The effect in clinical outcomes between both the treatment groups is also explored.Methods: The study included 53 patients into two cohorts with 30 from clopidogrel group and 23 from prasugrel group who underwent PCI for coronary artery disease. Patients were assigned either to clopidogrel or prasugrel group based on mehraan bleeding risk score. Hs-CRP was measured on 15thfollowup day. The predefined primary composite endpoint was myocardial infarction, stroke, vascular complications or death from cardiovascular causes.Results: In both treatment groups the changes in hs-CRP levels over time were identical (2.97±3.2 in clopidogrel vs. 4.47±4.1in prasugrel p:0.14). Clinical outcomes occurred in 3 cases in clopidogrel group and one patient had puncture site hematoma in prasugrel group (p: 0.72). In contrast no significant difference in hs-CRP was noted among those had adverse clinical outcomes (1.67±2.2 vs 3.12±3.3 p: 0.47). Baseline parameters height (158.3±7.7 vs 157.8±7.7p:0.80) weight (63.4±9.7 vs 63.8±9.6 p: 0.87) hypertension (17 vs 11 p: 0.58) diabetes (11 vs 8 p: 1.00) smokers (1 vs. 5 p: 0.06) are matched between both the groups. Clopidogrel group were elderly (63.1±9.6 vs 53.7±9.5 p: 0.001) and had higher systolic blood pressure (154.7±26.2 vs 138.7±18.7 p: 0.01). Clinical scenario like type of presentation (CSA 16 vs 9 p: 0.29) LV dysfunction (10 vs 10 p: 0.57) previousPCI (5 vs 4 p: 0.94) previous CABG (2 vs 0 p: 0.143) are identical in both groups. Lesion characteristics like calcification (15 vs 11 p:0.97) tortuosity(4 vs 3 p:0.94) angulation (2 vs 0p:0.49) ostial lesion ( 8 vs 5 p:0.75) thrombotic (0 vs 1 p:0.30) was similar in both the groups. Bifurcation lesion (6 vs 1 p:0.06) usage of Gp2B3A inhibitors(3 vs 0 p:0.06) was higher in clopidogrel group.Conclusions: Antiplatelet prasugrel and clopidogrel significantly did not affect inflammation post PCI as assessed by hs-CRP which is an established inflammatory marker. No significant difference in clinical outcomes in the follow-up between both the groups. Neither hs-CRP level was elevated in those with adverse clinical events.

scholarly journals Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial

2015 ◽  
Vol 75 (4) ◽  
pp. 709-714 ◽  
Author(s):  
Jeremy Sokolove ◽  
Michael Schiff ◽  
Roy Fleischmann ◽  
Michael E Weinblatt ◽  
Sean E Connolly ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Outcomes ◽  
Antibody Concentration ◽  
Treatment Groups ◽  
Cyclic Citrullinated Peptide ◽  
Remission Rates ◽  
Registration Number ◽  
Baseline Characteristics ◽  
Citrullinated Peptide

ObjectivesTo examine whether baseline anti-cyclic citrullinated peptide-2 (CCP2) antibody status and concentration correlated with clinical outcomes in patients treated with abatacept or adalimumab on background methotrexate (MTX) in the 2-year AMPLE (Abatacept versus adaliMumab comParison in bioLogic-naïvE rheumatoid arthritis subjects with background MTX) study.MethodsIn this exploratory analysis, anti-CCP2 antibody concentration was measured at baseline, and antibody-positive patients were divided into equal quartiles, Q1–Q4, representing increasing antibody concentrations. Clinical outcomes analysed by baseline anti-CCP2 status and quartile included change from baseline in disease activity and disability and remission rates.ResultsBaseline characteristics were generally comparable across quartiles and treatment groups. In both treatment groups, anti-CCP2 antibody-negative patients responded less well than antibody-positive patients. At year 2, improvements in disease activity and disability and remission rates were similar across Q1–Q3, but were numerically higher in Q4 in the abatacept group; in contrast, treatment effects were similar across all quartiles in the adalimumab group.ConclusionsIn AMPLE, baseline anti-CCP2 positivity was associated with a better response for abatacept and adalimumab. Patients with the highest baseline anti-CCP2 antibody concentrations had better clinical response with abatacept than patients with lower concentrations, an association that was not observed with adalimumab.Trial registration numberNCT00929864.

Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial

2019 ◽  
Vol 6 (3) ◽  
pp. 167-175 ◽  
Author(s):  
André M Nicolau ◽  
Ramon Corbalan ◽  
Jose C Nicolau ◽  
Christian T Ruff ◽  
Wolfgang Zierhut ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Concomitant Disease ◽  
Efficacy And Safety ◽  
Treatment Groups ◽  
Comorbidity Index ◽  
Post Hoc ◽  
The Impact ◽  
Burden Of Diseases

Abstract Aims Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs. Methods and results In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P &lt; 0.05 for each). The annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI = 0, 1, 2, 3, or ≥4 were 5.9%, 8.7%, 6.6%, 10.3%, and 13.6% (Ptrend &lt; 0.001). There were no significant interactions between treatment with HDER vs. warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction &gt; 0.10 for each). Conclusion  Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.

Shifting Treatment Patterns and Clinical Outcomes in Veterans Diagnosed with Waldenstrom Macroglobulinemia from 2006 to 2018

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 12-12
Author(s):  
Hsu-Chih Chien ◽  
Deborah Kay Morreall ◽  
Vikas Patil ◽  
Kelli M Rasmussen ◽  
Christina Yong ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Outcomes ◽  
Real World ◽  
Research Funding ◽  
Practice Patterns ◽  
Treatment Patterns ◽  
Clinical Settings ◽  
Treatment Groups ◽  
Treatment Regimens

Background Waldenström's Macroglobulinemia (WM) is a rare indolent lymphoma with an estimated 1,500 new cases diagnosed each year in the United States (US). Over the last decade, several treatments have been introduced into the WM therapeutics landscape including, bendamustine, bortezomib, and most recently oral Bruton's kinase inhibitor (ibrutinib). There is limited information in the adoption of these WM treatments in real-world clinical settings in the US. We describe the practice patterns and clinical outcomes of first-line (1L) treatment of WM in a nationwide cohort of Veterans. Methods Using Veteran Affairs electronic health records (EHR) data, we identified Veterans who were diagnosed and received 1L treatment for WM between January 2006 and December 2018 in the Veterans Health Administration (VHA). Human annotation of EHR clinical records confirmed the diagnosis and 1L treatment regimens. Patients with another cancer diagnosis or patients with documentation that 1L treatment was received outside the VHA were excluded. Eligible patients were followed until loss to follow-up, death, or the end of the study period (June 30, 2019). Patient demographics, disease characteristics, and treatment patterns were identified. Local polynomial regression model curves were generated to demonstrate treatment changes over time. Unadjusted progression-free survival (PFS) and the unadjusted overall survival (OS) are also provided. Results We identified 505 patients diagnosed with WM in VHA between January 2006 thru December 2018. Of these, 318 patients received 1L treatment, with a median time from diagnosis to 1L treatment of 1.2 months (95% confidence interval [CI]: 0.5-5 months). The median age of WM patients was 69.9 years (standard deviation [SD]: 9.4 years), with approximately 73% of WM patients ≥65 years old. Prior to 1L treatment, the median hemoglobin and platelets observed were similar across all treatment groups, regardless of first 1L treatment. However, the median immunoglobulin M (IgM) was substantially lower in patient's treated with ibrutinib (2,570 mg/dL [range: 422-9,001 mg/dL]) and single-agent rituximab (R), 2,855 mg/dL (range: 84-7,880 mg/dL) when compared to those treated with chlorambucil +/- rituximab (4,416 mg/dL [range: (9-8,130 mg/dL]) and bortezomib/dexamethasone +/- rituximab (BDR), 4,086 mg/dL (range: 16-9,944 mg/dL). MYD88 testing occurred in 40 (13%) of patients, with testing most frequently occurring in patients treated with bendamustine +/- rituximab (BR), ibrutinib, and BDR- likely reflecting increased adoption in later periods. Hepatitis C testing occurred in 61 (19%) of patients, with testing most frequently occurring in patients treated with dexamethasone, rituximab, and cyclophosphamide (DRC), BDR, and BR. Over the study observation period, 1L practice patterns shift significantly with increased adoption of BR, BDR and ibrutinib and de-adoption of chemotherapy (Figure 1). The median follow-up time for all patients was 44 months (range: 1-147 months), although a shorter median follow-up time was observed in patients treated with therapeutics in recent years, such as ibrutinib (18 months [range: 2-53 months]) and BR (23 months [range: 4-86 months]). The median unadjusted PFS for all WM patients was 44 months (95% CI: 37-58 months) and the median unadjusted overall survival (OS) was 94 months (95% CI: 82-117 months). Conclusions The introduction of numerous therapeutic options throughout the past decade has profoundly altered the treatment landscape for WM, suggesting a shift in 1L practices from chlorambucil to BDR, BR, and most recently ibrutinib which has been increasingly adopted, since its approval in 2015, especially in older patients, suggesting that it may provide an effective therapeutic option for patients who may not be able to tolerate more aggressive treatment regimens. Limitations of this study include the differences observed in follow-up time as well as the limited number of patients in some 1L treatment groups. Further research is required to establish the long-term benefits and potential treatment-related toxicities of WM treatments in real-world clinical settings. Disclosures Sauer: Roche: Research Funding; Genentech, Inc.: Research Funding; Pharmacyclics: Research Funding; AbbVie: Research Funding. Halwani:AbbVie: Research Funding; Takeda: Research Funding; Roche: Research Funding; Genentech, Inc.: Research Funding; Miragen: Research Funding; Immunedesign: Research Funding; Kyowa Hakko Kirin: Research Funding; Seattle Genetics: Research Funding; Amgen: Research Funding; Pharmacyclics: Research Funding; Bristol Myers Squibb: Research Funding.

Abstract WP116: Association Between Smoking Status, Platelet Function and Clinical Outcomes of Ticagrelor versus Clopidogrel in Patients With Minor Stroke or Transient Ischemic Attack

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Yingying Yang ◽  
Yilong Wang
Keyword(s):  
Clinical Outcomes ◽  
Platelet Function ◽  
Platelet Reactivity ◽  
Smoking Status ◽  
Minor Stroke ◽  
Carrier Status ◽  
Bleeding Events ◽  
Vascular Events ◽  
Treatment Groups ◽  
The Impact

Background: Association between smoking status, platelet function and clinical outcomes of ticagrelor versus clopidogrel in patients with minor stroke or transient ischemic stroke (TIA) remains unclear. Methods: A subgroup analysis was conducted of Platelet Reactivity in Acute Non-disabling Cerebrovascular Events (PRINCE) trial. PRINCE trial was a randomized, prospective, multicenter, open-label, active-controlled, and blind-endpoint trial, which randomized patients with acute minor stroke, or TIA, to ticagrelor plus aspirin or clopidogrel plus aspirin within 24 hours of symptoms onset. Patients who smoked at least one cigarette per day for at least one year in their lives were defined as smokers. Platelet reactivity was assessed by the VerifyNow P2Y12 assay at baseline, 7+2 days and 90±7 days. High-on-treatment platelet reactivity (HOPR) was defined as P2Y12 reaction units >208.Clinical outcomes included any stroke, composite clinical vascular events and bleeding events at 90 days. Results: Among 675 patients enrolled in the PRINCE trial, 370 patients (54.8%) were smokers. At 7+2 days, the proportion of HOPR in ticagrelor versus clopidogrel was significantly lower in smokers (5.2% versus 21.8%) and non-smokers (2.3% versus 34.4%). There were marginal significant interactions between treatment groups and smoking status for the proportion of HOPR ( P =0.058). There were significant interactions between treatment groups and carrier status of CYP2C19 LOF alleles for the proportion of HOPR among smokers ( P =0.04), but no significant interactions were found among non-smokers ( P =0.91). At 90±7 days, there were significant interactions between treatment groups and smoking status for the risk of new stroke (smokers, 7.0% versus 4.9%, hazard ratio [HR], 1.57 [95%CI, 0.65-3.79], P =0.39; non-smokers, 5.3% versus 13.5%, HR, 0.39 [95%CI, 0.17-0.91], P =0.01. P for interaction=0.02). Conclusions: Among patients with minor stroke or TIA, ticagrelor might be superior to clopidogrel in inhibiting platelet reactivity and reducing the risk of stroke, particularly in non-smokers. Carrier status of CYP2C19 LOF alleles might play a role in the impact of smoking status. Clinical Trial Registration : Clinicaltrials.gov NCT02506140.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

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