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This retrospective observational study aimed to compare healthcare resource utilization and costs of Medicare beneficiaries with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who received ibrutinib versus chemoimmunotherapy (CIT) in first line (1 L).Fee-for-service (FFS) and Medicare Advantage (MA) claims data were used to identify adults with a CLL/SLL diagnosis initiating 1 L ibrutinib single agent or CIT between 4 March 2016 and 30 September 2017 (index date). HRU and costs (Medicare spending) were evaluated during 1 L Oncology Care Model (1 L OCM) episodes (the first six months post-index) and over the observed 1 L duration. Patients' baseline characteristics were balanced using inverse probability of treatment weighting. Mean monthly cost differences (MMCDs) obtained from ordinary least square regressions were used to compare costs between ibrutinib and CIT cohorts.In the Medicare FFS dataset (ibrutinib:In Medicare patients with CLL/SLL, 1 L ibrutinib single agent was associated with total monthly cost savings relative to 1 L CIT, driven by lower monthly medical costs that fully offset higher monthly pharmacy costs.

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is the most common adult leukemia, accounting for ≈ 37% of all leukemias in the United States. Limited real-word evidence is available on the outcomes of ibrutinib use among previously untreated patients in the U.S. Veterans Health Administration (VHA) population diagnosed with CLL/SLL.To (a) evaluate time to next treatment (TTNT) among U.S. veterans with CLL/SLL who initiated ibrutinib versus chemoimmunotherapy (CIT) in first line (1L) and 1L ibrutinib versus ibrutinib in later lines (2L+) and (b) compare health care resource utilization (HRU) and costs between the 1L ibrutinib and CIT cohorts.Adults with CLL/SLL and claims for 1L single-agent ibrutinib or CIT (index date = first prescription claim date) were included from Veterans Health Administration Data (April 1, 2013-March 31, 2018). A subset of the CIT 1L cohort with evidence of ibrutinib in 2L/3L was defined as the ibrutinib 2L+ cohort. Kaplan-Meier curves and Cox proportional hazard models were used to evaluate TTNT, and generalized linear models were used to determine all-cause per patient per month (PPPM) HRU and costs during 1L among propensity score-matched (PSM) cohorts.After PSM, 614 patients were included in each of the 1L ibrutinib and 1L CIT cohorts, and 149 were included in each of the 1L ibrutinib and 2L+ ibrutinib cohorts. The 1L ibrutinib cohort had significantly longer TTNT compared with each of the 1L CIT and 2L+ ibrutinib cohorts (These findings demonstrate that among U.S. veterans with CLL/SLL, 1L ibrutinib use was associated with significantly longer TTNT versus that of 1L CIT. Similarly, early treatment with ibrutinib was associated with longer TTNT as compared to ibrutinib use in later lines of therapy. Moreover, 1L ibrutinib was associated with lower HRU and medical costs compared with 1L CIT, completely offsetting the higher pharmacy costs related to 1L ibrutinib treatment.This research was sponsored by Janssen Scientific Affairs. The analyses were performed by STATinMED Research. Huang is an employee of Janssen Scientific Affairs and may own company stock. Sundaram was an employee of Janssen Scientific Affairs at the time this study was conducted. Borra and Janjan are employees of STATinMED Research, a paid consultant to the study sponsor. Wang, Li, and Shrestha were employees of STATinMED Research at the time this study was conducted.

Introduction Prior studies have reported that hidradenitis suppurativa (HS) is accompanied by a myriad of physical and mental conditions. However, given the small sample sizes and the limited number of pre-selected comorbidities, these studies do not provide a complete picture of the comorbidity burden of HS in the USA. Moreover, the relationship between HS severity and comorbidity burden has yet to be characterized. Using a large US claims database, we estimated the comorbidity burden associated with HS, stratified by disease severity. Methods A retrospective matched cohort design was used. Patients with HS were classified into two severity cohorts (milder and more severe) using an empirical algorithm based on treatments received. The comorbidity burden was compared between each HS cohort and their matched HS-free cohort, and between patients with milder vs. those with more severe forms of HS. Results Several physical and mental comorbidities were found to be more prevalent in both cohorts of patients with milder and more severe forms of HS than in their matched HS-free cohorts. The comorbidity burden also increased greatly as the disease progressed to more severe forms. Conclusions The results of this study highlight the complexity of the comorbidity burden of HS patients and the need for a multidisciplinary approach to optimize the management of HS and its numerous associated comorbidities. Funding AbbVie, Inc. Electronic supplementary material The online version of this article (10.1007/s13555-018-0264-z) contains supplementary material, which is available to authorized users.

To compare outcomes between adalimumab and etanercept in the treatment of moderate to severe plaque psoriasis.Study groups included patients randomized to adalimumab or placebo (REVEAL and CHAMPION trials) and those randomized to etanercept or placebo (M10-114 and M10-315 trials). Week 12 outcomes were compared between patients receiving adalimumab and those receiving etanercept after adjusting for cross-trial differences in patient characteristics using propensity score weighting and after subtracting effects of placebo. Outcomes included proportion of patients achieving 75% or more, 90% or more, and 100% reductions from baseline in the Psoriasis Area and Severity Index (PASI75, PASI90, PASI100, respectively), symptom resolution (pruritus = 0; psoriatic pain = 0), lesion resolution (minimal scores for plaque signs erythema, desquamation, and induration, and by body regions head, upper limbs, trunk, and lower limbs), absence of skin-related quality-of-life impact (Dermatology Life Quality Index [DLQI] = 0), "complete disease control" (patient's global assessment [PtGA] = 0), and adverse events.After adjustment, baseline characteristics were balanced among study groups (adalimumab = 875 vs. placebo = 427; etanercept = 260 vs. placebo = 130). Compared with etanercept, adalimumab was associated with significantly better placebo-adjusted outcomes (PASI75: 62.3% vs. 42.6%; PASI90: 35.9% vs. 12.1%; PASI100: 13.1% vs. 4.9%; pruritus: 24.7% vs. 13.0%; psoriatic pain: 27.4% vs. 8.7%; DLQI: 27.7% vs. 11.7%; and PtGA: 16.4% vs. 10.6%; all P0.05), except for similar rates of adverse events and head-specific lesion resolution.Compared with etanercept, adalimumab treatment for moderate to severe plaque psoriasis was associated with greater PASI reduction, higher rates of resolution of skin signs and symptoms, and greater improvements in dermatological life quality.

informCLL is the first United States-based registry of patients with chronic lymphocytic leukemia that initiated enrollment after approval of novel targeted agents. Prognostic/predictive testing rates and chronic lymphocytic leukemia treatment selection with availability of novel agents have not been previously investigated in clinical practice. Results from this interim analysis demonstrate that prognostic/predictive testing was infrequently used to guide treatment selection, potentially inhibiting beneficial outcomes for patients. Introduction: The therapeutic landscape for chronic lymphocytic leukemia (CLL) has significantly shifted with the approval of novel agents. Understanding current prognostic testing and treatment practices in this new era is critical. Beginning enrollment in 2015, informCLL is the first United States-based real-world, prospective, observational registry that initiated enrollment after approval of novel agents. Patients and Methods: Eligible patients were age ≥ 18 years, started CLL treatment within 30 days of enrollment, and provided consent. For this planned interim analysis, treatments were classified into 5 groups: ibrutinib, chemoimmunotherapy, chemotherapy, immunotherapy, and other novel agents. Results: Frequency of prognostic testing and treatment patterns are reported among 840 patients (459 previously untreated; 381 relapsed/refractory), enrolled largely (96%) from community practice settings. Testing for chromosomal abnormalities by fluorescence in situ hybridization, TP53 mutation, or IGHV mutation status occurred infrequently among all patients (31%, 11%, and 11%, respectively). Chemoimmunotherapy was the most common treatment in previously untreated patients (42%), whereas ibrutinib was the most common treatment among relapsed/ refractory patients (51%). Of patients who tested positive for del(17p) or TP53 mutation, 34% and 26% received chemoimmunotherapy, respectively. Among patients who did not have fluorescence in situ hybridization or TP53 mutation testing prior to enrollment, 33% and 32% received chemoimmunotherapy, respectively. Conclusion: Our findings indicate that prognostic testing rates were poor, and approximately one-third of high-risk patients (del[17p] and TP53) received chemoimmunotherapy, which is not aligned with current CLL treatment recommendations. This represents an opportunity to educate and alert health care professionals about the necessity of prognostic testing to guide optimal CLL treatment decisions.

Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor α, showed efficacy against hidradenitis suppurativa.PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled periods. In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks. In period 2, patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks. The primary end point was a clinical response, defined as at least a 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in abscess or draining-fistula counts, at week 12.We enrolled 307 patients in PIONEER I and 326 in PIONEER II. Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I (P=0.003) and 58.9% versus 27.6% in PIONEER II (P0.001). Patients receiving adalimumab had significantly greater improvement than the placebo groups in rank-ordered secondary outcomes (lesions, pain, and the modified Sartorius score for disease severity) at week 12 in PIONEER II only. Serious adverse events in period 1 (excluding worsening of underlying disease) occurred in 1.3% of patients receiving adalimumab and 1.3% of those receiving placebo in PIONEER I and in 1.8% and 3.7% of patients, respectively, in PIONEER II. In period 2, the rates of serious adverse events were 4.6% or less in all the groups in both studies, with no significant between-group differences.Treatment with adalimumab (40 mg weekly), as compared with placebo, resulted in significantly higher clinical response rates in both trials at 12 weeks; rates of serious adverse events were similar in the study groups. (Funded by AbbVie; ClinicalTrials.gov numbers, NCT01468207 and NCT01468233 for PIONEER I and PIONEER II, respectively.).

Background: The clinical benefits of biologic therapies for moderate-to-severe psoriasis are well established, but wide variations exist in patient response. Objectives: To determine the number needed to treat (NNT) to achieve a 75% and 90% reduction in the Psoriasis Area and Severity Index (PASI-75/90) with FDA-approved agents and evaluate the incremental cost per PASI-75 or PASI-90 responder. Methods: The relative probabilities of achieving PASI-75 and PASI-90, as well as NNTs, were estimated using a network meta-analysis. Costs (2017 USD) included drug acquisition and administration. The incremental cost per PASI-75 or PASI-90 responder for each treatment was estimated for the clinical trial period, and annually. Results: Compared with supportive care, the NNT to achieve PASI-75 was 1.18 for ixekizumab, 1.29 for secukinumab 300 mg, 1.37 for infliximab, 1.48 for adalimumab, 1.53 for secukinumab 150 mg, 1.58 for ustekinumab, 2.25 for etanercept, and 3.71 for apremilast. The one-year incremental cost per PASI-75 responder relative to supportive care was $59,830 for infliximab, $88,775 for secukinumab 300 mg, $91,837 for adalimumab, $95,898 for ixekizumab, $97,363 for ustekinumab, $105,131 for secukinumab 150 mg, $129,665 for apremilast, and $159,328 for etanercept. Results were similar for PASI-90. Conclusion: The NNT and incremental cost per responder are meaningful ways to assess comparative effectiveness and cost effectiveness among psoriasis treatments.

Background Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. Objective This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Methods Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Results Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [ P .001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. Limitations Patients with less than 5% BSA involvement were not eligible for enrollment. Conclusions After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.

dear editor, Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic, inflammatory skin disease affecting terminal hair follicles in apocrine-gland-bearing skin.1 Associated comorbidities include depression,2 obesity3 and metabolic syndrome.4 The objective of the current analysis of patients with moderate-to-severe HS was to identify the most common comorbidities, their prevalence according to the level of HS disease burden (high vs. medium) and any association between baseline characteristics and the risk for the comorbidity. These patients, representing one of the largest HS groups to be evaluated to date, were adults from a 52-week, phase 2, randomised, double-blind, placebo-controlled trial of adalimumab treatment,5 who had at least moderate disease [HS Physician's Global Assessment (HS-PGA) grade ≥ 3; 0–5 scale]. Additional inclusion/exclusion criteria were published previously.5 Baseline comorbidities were identified with patient reports and medical histories. The following conditions were defined: hypertension, use of antihypertensive medication and/or self-reported history; uncontrolled hypertension, systolic/diastolic blood pressure (SBP/DBP) ≥ 140/≥ 90 mmHg; depression, Patient Health Questionnaire 9 (PHQ-9) score ≥ 10;6 morbid obesity, body mass index (BMI) ≥ 40 kg m−2; hyperlipidaemia, total cholesterol ≥ 240 mg dL−1; high HS disease burden, HS-PGA > 3 and/or Hurley stage III; and medium HS disease burden, HS-PGA ≤ 3 and Hurley stage II.5 All patients with available baseline values were included in this analysis. All statistical tests were two-sided and significant at 0·05. Associations between the most common comorbidities and baseline characteristics were evaluated by logistic regression. The odds ratio (OR) with 95% Wald confidence interval (CI) was provided. Final models were chosen by stepwise selection with a P-value of 0·15 for both entry and stay. Model selection was conducted per Akaike information criteria and Bayesian information criteria, which confirmed the final models selected by the stepwise selection method. Of the 154 patients in this analysis, 60 (39·0%) had high HS disease burden and 94 (61·0%) had medium burden. Mean high-sensitivity C-reactive protein (CRP) was almost four times higher in the high vs. medium disease burden groups (32·7 mg L−1 vs. 8·7 mg L−1). Combining self-report and medical examination results, 39·6% of patients had hypertension, 38·3% were morbidly obese and 48·1% had depression. The incidence of modifiable cardiovascular risk factors (Table​(Table1)1) revealed that > 50% of patients were smokers, overweight or had hypertension. Other cardiovascular risk factors included hyperlipidaemia (11·7%) and diabetes mellitus (6·5%). Over one-third of patients (35·7%) had two cardiovascular risk factors (Table​(Table11). Table 1 Baseline status of enrolled patients with hidradenitis suppurativa (HS) Of the 40·3% of patients who had and/or were diagnosed with hypertension, or were receiving antihypertensive medication (Fig.​(Fig.1a),1a), 53% had been diagnosed with hypertension, and 31% had been both diagnosed and treated. Of the latter, 53% had reached the treatment goal (SBP/DBP

Health care costs, health care resource utilization, and time to next treatment were compared among patients with chronic lymphocytic leukemia initiated on front-line ibrutinib single agent (N = 322) or chemoimmunotherapy (N = 839). Ibrutinib was associated with lower total health care costs driven by lower medical costs (despite higher pharmacy costs), and longer time to next treatment versus chemoimmunotherapy. Background: Studies assessing ibrutinib’s economic burden versus chemoimmunotherapy (CIT) focused on pharmacy costs but not medical costs. This study compared time to next treatment (TTNT), health care resource utilization (HRU), and total direct costs among patients with chronic lymphocytic leukemia (CLL) initiating front-line ibrutinib single agent (Ibr) or CIT. Materials and Methods: Optum Clinformatics Extended DataMart De-Identified Databases were used to identify adults with ≥ 2 claims with a CLL diagnosis initiating front-line Ibr or CIT from February 12, 2014 to June 30, 2017. Inverse probability of treatment weighting was used to control for potential differences in baseline characteristics between the Ibr and CIT cohorts. Two periods were considered: entire front-line therapy (until initiation of second-line therapy) and first 6 months of front-line therapy. Comparisons with a subgroup of CIT patients initiating bendamustine/rituximab (BR) were also conducted. Results: TTNT was significantly longer for Ibr (N = 322) relative to CIT (N = 839; hazard ratio, 0.54; P = .0163; Kaplan-Meier rates [24 months]: Ibr = 88.6%, CIT = 75.9%) and the subset of CIT patients treated with BR (N = 455; hazard ratio, 0.54; P = .0208; Kaplan-Meier rates [24 months]: Ibr = 89.0%, BR = 79.0%). During the entire front-line therapy, Ibr patients had significantly fewer monthly days with outpatient visits (rate ratio = 0.75; P = .0200). Ibrutinib’s higher pharmacy costs (mean monthly cost difference [MMCD] = $6,849; P < .0001) were offset by lower medical costs (MMCD = −$10,615; P < .0001), yielding net savings (MMCD = −$3,766; P < .0001) versus CIT. Ibr was associated with net savings (MMCD = −$5,569; P < .0001) versus BR. Cost savings and reductions in HRU were more pronounced during the first 6 months of front-line therapy. Conclusion: During front-line CLL treatment, Ibr was associated with longer TTNT, fewer monthly days with outpatient visits, and net monthly total cost reduction versus CIT and BR.

There is an increasing concern in the role of microRNA (miRNA) in the pathogenesis of bone metastasis (BM) secondary to prostate cancer (CaP). In this exploratory study, we hypothesized that the expression of vinculin (VCL) and chemokine X3C ligand 1 (CX3CL1) might be downregulated in clinical samples, most likely due to the posttranscriptional modification by microRNAs. Targeted genes would be upregulated upon transfection of the bone metastatic prostate cancer cell line, PC3, with specific microRNA inhibitors.MicroRNA software predicted that miR21 targets VCL while miR29a targets CX3CL1. Twenty benign prostatic hyperplasia (BPH) and 16 high grade CaP formalinfixed paraffin embedded (FFPE) specimens were analysed. From the bone scan results, high grade CaP samples were further classified into CaP with no BM and CaP with BM. Transient transfection with respective microRNA inhibitors was done in both RWPE1 (normal) and PC3 cell lines. QPCR was performed in all FFPE samples and transfected cell lines to measure VCL and CX3CL1 levels.QPCR confirmed that VCL messenger RNA (mRNA) was significantly down regulated while CX3CL1 was upregulated in all FFPE specimens. Transient transfection with microRNA inhibitors in PC3 cells followed by qPCR of the targeted genes showed that VCL mRNA was significantly up regulated while CX3CL1 mRNA was significantly downregulated compared to the RWPE1 case.The downregulation of VCL in FFPE specimens is most likely regulated by miR21 based on the in vitro evidence but the exact mechanism of how miR21 can regulate VCL is unclear. Upregulated in CaP, CX3CL1 was found not regulated by miR29a. More microRNA screening is required to understand the regulation of this chemokine in CaP with bone metastasis. Understanding miRNAmRNA interactions may provide additional knowledge for individualized study of cancers.

Background: Hidradenitis suppurativa (HS) is a chronic, recurrent, inflammatory skin disease with frequent comorbidities of painand depression. Adalimumab treatment for 16 weeks improved HS lesions significantly versus placebo (NCT00918255).Objective: The relationship between pain and depressive symptoms and the effects of adalimumab on each was examined in this post hoc analysis.Methods: Patients with moderate to severe HS (N=154) were randomized 1:1:1 to adalimumab 40 mg weekly (ew), adalimumab 40 mg every other week (eow), or placebo. Skin pain was assessed using a visual analog scale (VAS; 0–100 mm). Depressive symptoms were assessed using the 9-item Patient Health Questionnaire (PHQ-9; score ≥10 indicative of depression).Results: At baseline, overall mean±SD pain VAS was 54.3±26.5 mm and 41.8% of patients had PHQ-9 scores ≥10. At baseline, VAS pain scores (mean±SD) were significantly higher (P

Introduction: Novel targeted therapies greatly improved outcomes of patients with chronic lymphocytic leukemia (CLL). Among these, ibrutinib is the only one approved in the front-line (1L) setting for patients with or without del(17p) or TP53 mutations. This study aims to compare healthcare resource utilization (HRU), costs, and time to next treatment (TTNT), following initiation of 1L ibrutinib single agent versus CIT and in particular bendamustine/rituximab (BR), in real-world. Methods: The Optum Clinformatics® Extended DataMart De-Identified Databases (01/2004-06/2017) was used to identify adults with CLL diagnosis initiating 1L ibrutinib single agent or CIT (index date) on 02/12/2014 or after. For CIT, only combinations of chemotherapy and CD20 antibody agents recommended by the National Comprehensive Cancer Network guidelines were considered. Patients were also required to have ≥12 months and ≥30 days of continuous eligibility pre- and post-index date, respectively. For each comparison, patients' baseline characteristics were balanced using inverse probability of treatment weighting (IPTW). HRU, costs, and TTNT, were evaluated over 1L therapy. Mean monthly cost differences (MMCD) and rate ratios (RR) obtained from generalized linear models were used to compare costs and HRU, respectively, along with 500-sample bootstrap confidence intervals and P-values. TTNT was defined as the time from initiation of 1L treatment to the initiation of a new antineoplastic agent that was not part of the 1L regimen. TTNT comparisons were performed using Kaplan-Meier (KM) curves with log-rank tests. The hazards of initiating a new treatment were compared between the cohorts using hazard ratios (HRs) obtained from Cox models. Results: Of 1,161 1L patients, 322 initiated ibrutinib and 839 initiated CIT, including 455 on BR. After IPTW, cohorts had comparable baseline characteristics. CIT patients had significantly more days with outpatient (OP) services (RR=0.75; P Ibrutinib patients also had fewer OP visits compared to BR patients, mainly due to drug administration-related OP visits (Fig. 1). Relative to BR, ibrutinib patients' higher pharmacy costs (MMCD=$7,002; P KM analysis of TTNT revealed that, at 24 months post-index, 88.6% of ibrutinib patients did not initiate a new treatment compared to 75.9% among CIT patients (log-rank P=0.0347; Fig. 3A). The hazard of initiating a new treatment was also lower for ibrutinib when compared to CIT, with significant HRs of 0.30 (P=0.0045), 0.59 (P=0.0415), and 0.54 (P=0.0171) at 3, 18, and 24 months post-index, respectively (Fig. 3A). The proportion of patients who did not initiate a new treatment 24 months post-index was significantly higher in ibrutinib cohort than in BR cohort (89.0% versus 79.0%; log-rank P=0.0421). The hazard of initiating a new treatment was also lower for ibrutinib compared to BR, with significant HRs of 0.40 (P=0.0449), 0.54 (P=0.0410), 0.55 (P=0.0360), 0.57 (P=0.0346), and 0.54 (P=0.0219) at 3, 9, 12, 18, and 24 months post-index, respectively (Fig. 3B). Conclusion: During 1L CLL treatment, ibrutinib patients had higher pharmacy costs that were fully offset by lower medical costs, resulting in net total cost reduction compared to CIT or BR patients. In addition to fewer OP visits and lower OP costs related to the antineoplastic treatment, ibrutinib was also associated with lower cost in other OP services. TTNT was significantly longer among ibrutinib patients vs. CIT or BR patients. Furthermore, consistent with the high rates of progression-free survival observed among ibrutinib patients in clinical trials, nearly 90% of patients did not initiate a new treatment after 24 months of follow-up. Disclosures Wang: Janssen Scientific Affairs, LLC: Employment, Equity Ownership. Emond:Janssen Scientific Affairs, LLC: Research Funding. Romdhani:Janssen Scientific Affairs, LLC: Research Funding. Lefebvre:Janssen Scientific Affairs, LLC: Research Funding. Sundaram:Johnson & Johnson: Employment, Equity Ownership, Other: Travel; AbbVie: Employment, Equity Ownership, Other: Travel. Mato:TG Therapeutics: Research Funding; Regeneron: Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria; Sunesis: Honoraria, Research Funding; Prime Oncology: Speakers Bureau; Abbvie: Consultancy; Acerta: Research Funding; AstraZeneca: Consultancy; Celgene: Consultancy.

Background : Prior to the approvals of ibrutinib (ibr), idelalisib, and venetoclax, data from the Connect CLL registry showed that across 199 US centers only 65% of patients (pts) had FISH testing and 6% had IGHV testing performed prior to the first chronic lymphocytic leukemia (CLL)-directed treatment (tx), and 40% had repeat FISH testing prior to a subsequent therapy (Mato, Br J Haematol 2016). In today's era, molecular-genetic testing should be universally performed to guide tx decisions for pts with CLL, particularly for pts with 17p deletion (del[17p]), TP53 mutation, and/or unmutated IGHV (U-CLL), as recommended by several guidelines. Whether the widespread availability of novel agents has improved prognostic testing patterns and if those results are appropriately utilized in selecting therapies remain important unanswered questions. InformCLL (NCT02582879) is a US, multicenter, prospective, observational real-world registry of pts with CLL receiving various lines of tx across 150 centers (96% community, 4% academic). This analysis describes rates of prognostic testing in pts with CLL stratified by line of therapy, proportions of pts with specific abnormalities, and current tx patterns in clinical practice in this registry. Methods : Enrollment began in Oct 2015. Eligible pts had to be ≥18 years (y), start approved anti-CLL tx within 30 days of enrollment, and provide consent. First tx at enrollment was classified into 5 groups: chemoimmunotherapy (CIT), chemotherapy (CT), immunotherapy (IT), ibr, and other novel agents. For this interim analysis (data cut: Feb 2018), the number of pts with CLL who had testing performed for FISH, TP53 mutational status, and IGHV mutational status, as well as CLL tx for subgroups of pts stratified by abnormality, was summarized as frequency counts and percentages. Results : At the time of this analysis, the registry had enrolled 840 pts (459 previously untreated; 381 relapsed or refractory [R/R]). The majority of pts were male (64%) and Caucasian (92%); median (range) age was 70y (34-95), and median (range) Charlson Comorbidity Index was 2 (0-9). Overall, prognostic biomarker testing was performed infrequently. Among all pts (N=840), 262 (31%) had FISH testing, 89 (11%) had testing performed for TP53 mutation, and 94 (11%) had testing for IGHV mutational status (Table 1). Among 459 pts tested prior to first-line tx, 164 (36%) had testing for FISH, 54 (12%) for TP53, and 55 (12%) for IGHV; among 381 R/R pts, 98 (26%) had testing for FISH, 35 (9%) for TP53, and 39 (10%) for IGHV. For tested pts, 70/262 (27%) pts had del(17p), 23/89 (26%) had mutated TP53, and 69/94 (73%) had U-CLL. For previously untreated tested pts, 47/164 (29%) had del(17p), 14/54 (26%) had mutated TP53, and 35/55 (64%) had U-CLL; for tested R/R pts, 23/98 (23%) had del(17p), 9/35 (26%) had mutated TP53, and 34/39 (87%) had U-CLL. Among 70 pts with del(17p), the most common tx was ibr (n=38; 54%); however, a considerable proportion of pts received CT/CIT (n=24; 34%) (Table 2). In 47 previously untreated pts with del(17p), 27 (57%) received ibr and 16 (34%) received CT/CIT; in 23 R/R pts with del(17p), 11 (48%) received ibr and 8 (35%) CT/CIT. Among 23 pts with mutated TP53, 15 (65%) were treated with ibr, while 7 (30%) with CT/CIT. Of 14 previously untreated pts with mutated TP53, 9 (64%) received ibr and 5 (36%) CT/CIT; of 9 R/R pts with mutated TP53, 6 (67%) received ibr and 2 (22%) CT/CIT. Among 69 pts with U-CLL, 30 (43%) were treated with ibr and 32 (46%) with CT/CIT. In 35 previously untreated pts with U-CLL, CT/CIT was more common (n=20; 57%) than ibr (n=13; 37%), while in 34 R/R pts with U-CLL, ibr was more common (n=17; 50%) than CT/CIT (n=12; 35%). Conclusions : There remains a considerable lack of prognostic marker testing among pts with CLL in the modern era. These findings, as compared to prior registry results, suggest that the advent of novel agents and specific testing guidelines (eg, iwCLL) have not improved prognostic testing patterns in the real-world setting. Moreover, of pts tested who had abnormalities such as del(17p), TP53 mutation, or U-CLL, approximately one-third still received CIT. These results underscore a need to educate on how to utilize these markers to guide CLL tx decisions for optimal clinical outcomes. Additional evaluations (eg, regression analyses) to identify factors associated with failure to perform FISH, TP53, and IGHV testing are planned. Disclosures Mato: Portola: Research Funding; Celgene: Consultancy; AstraZeneca: Consultancy; AbbVie: Consultancy, Research Funding; Medscape: Honoraria; TG Therapeutics: Consultancy, Research Funding; Prime Oncology: Honoraria; Regeneron: Research Funding; Johnson & Johnson: Consultancy; Acerta: Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Barrientos:Janssen: Consultancy; Gilead: Consultancy, Research Funding; AbbVie: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Brander:BeiGene: Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Genentech: Consultancy, Honoraria, Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Novartis: Consultancy, Other: DSMB; DTRM: Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Teva: Consultancy, Honoraria; TG Therapeutics: Consultancy, Honoraria, Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Acerta: Other: Institutional research funding for non investigator initiated clinical trial, Research Funding. Pagel:Pharmacyclics, an AbbVie Company: Consultancy; Gilead: Consultancy. Kadish:Pharmacyclics, an AbbVie Company: Speakers Bureau; Celgene: Speakers Bureau; Janssen: Speakers Bureau; Takeda: Speakers Bureau. Ghosh:Celgene: Consultancy; PCYC: Consultancy, Research Funding, Speakers Bureau; Gilead: Consultancy, Speakers Bureau; Pharmacyclics, an Abbvie Company: Consultancy, Research Funding, Speakers Bureau; SGN: Consultancy, Research Funding, Speakers Bureau; Forty seven Inc: Research Funding; TG Therapeutics: Honoraria, Research Funding; F. Hoffman-La Roche Ltd: Research Funding; Genentech: Research Funding; Spectrum: Consultancy; Abbvie: Consultancy, Speakers Bureau; Juno: Consultancy, Research Funding. Giafis:Pharmacyclics, an AbbVie Company: Employment, Other: Travel; AbbVie: Equity Ownership. Ipe:AbbVie: Equity Ownership; Pharmacyclics, an AbbVie Company: Employment, Other: Travel. Upasani:Pharmacyclics, an AbbVie Company (self and immediate family member): Employment; AbbVie (self and immediate family member): Equity Ownership. Sundaram:AbbVie: Employment, Equity Ownership, Other: Travel; Johnson & Johnson: Employment, Equity Ownership, Other: Travel. Ferrante:Janssen: Employment, Equity Ownership. Amaya-Chanaga:AbbVie: Equity Ownership, Other: Research performed while employed as an investigator of this study at UCSD. Review and approval of abstract performed while employed at Pharmacyclics, LLC, an AbbVie Company.; Pharmacyclics, an AbbVie Company: Employment, Other: Research performed while employed as an investigator of this study at UCSD. Review and approval of abstract performed while employed at Pharmacyclics, LLC, an AbbVie Company.. Iyengar:Pharmacyclics, an AbbVie company: Employment; AbbVie: Equity Ownership; Express Scripts: Patents & Royalties. Sharman:Acerta: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding.

Background : Chronic lymphocytic leukemia (CLL) treatment (tx) has changed dramatically with the emergence of novel targeted therapies, and real-world data from observational studies continue to improve our understanding of tx patterns/outcomes. Beginning enrollment Oct 2015, informCLL (NCT02582879) began as a US, multicenter, prospective, observational real-world registry of patients (pts) with CLL who received CLL tx. From registry data, we describe demographic and clinical characteristics of pts with CLL, as well as tx patterns, dosing, and sequencing in clinical practice. Methods : In the informCLL registry, 96% of recruiting sites across the US were community hematology-oncology sites. For this planned interim analysis (data cut: Feb 2018), txs were classified into 5 groups based on first tx at enrollment: chemoimmunotherapy (CIT), chemotherapy (CT), immunotherapy (IT), ibrutinib (ibr), and other novel agents. Eligible pts had to be ≥18 years (y), initiate tx of approved anti-CLL therapy within 30 days of enrollment, and provide consent. Categorical variables were summarized as frequency counts and percentages. Continuous variables were summarized as median, range, mean, and standard deviation. Results : 840 pts (previously untreated, n=459; relapsed or refractory [R/R], n=381) were enrolled. Median age was 70y (previously untreated=69y; R/R=71y). Most pts were male (64%), Caucasian (92%), and presented with ECOG PS 0/1 (previously untreated: 88%; R/R: 86%) (Table 1). 45% of previously untreated and 57% of R/R pts presented with Rai stage III/IV. Hypertension and type 2 diabetes were the most common comorbidities. At enrollment, the 3 most common txs were ibr (44%), CIT (34%), and IT (15%). In previously untreated pts, CIT was the most common tx (overall=42%; bendamustine+rituximab [BR]=20%, fludarabine+cyclophosphamide+rituximab [FCR]=10%, obinutuzumab+chlorambucil [GC]=9%) and single-agent ibr was the most common novel agent (38%). In R/R pts, single-agent ibr was the most common tx (48%). In pts Conclusions : The most common agent used across all lines of tx was ibr. Most ibr-treated pts started at the FDA-recommended once-daily dose of 420 mg, with few dose interruptions/reductions. Most pts who received BR, FCR, or GC did not receive 6C of tx. Of pts who initiated subsequent tx, ibr was commonly used in pts who received IT, CIT, or CT. Few pts who received ibr switched to subsequent therapy. Continued follow up will further inform tx practices and enhance our understanding of CLL tx in the real-world setting. Disclosures Sharman: Pharmacyclics, an AbbVie Company: Consultancy, Research Funding; Acerta: Consultancy, Research Funding. Barrientos:Janssen: Consultancy; Gilead: Consultancy, Research Funding; AbbVie: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Brander:Teva: Consultancy, Honoraria; Genentech: Consultancy, Honoraria, Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; DTRM: Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; BeiGene: Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Acerta: Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Novartis: Consultancy, Other: DSMB; TG Therapeutics: Consultancy, Honoraria, Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; AbbVie: Consultancy, Honoraria, Other: Institutional research funding for non investigator initiated clinical trial, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Honoraria, Research Funding. Pagel:Gilead: Consultancy; Pharmacyclics, an AbbVie Company: Consultancy. Kadish:Janssen: Speakers Bureau; Celgene: Speakers Bureau; Takeda: Speakers Bureau; Pharmacyclics, an AbbVie Company: Speakers Bureau. Ghosh:Celgene: Consultancy; PCYC: Consultancy, Research Funding, Speakers Bureau; Gilead: Consultancy, Speakers Bureau; Abbvie: Consultancy, Speakers Bureau; F. Hoffman-La Roche Ltd: Research Funding; Pharmacyclics, an Abbvie Company: Consultancy, Research Funding, Speakers Bureau; Genentech: Research Funding; TG Therapeutics: Honoraria, Research Funding; Spectrum: Consultancy; Forty seven Inc: Research Funding; SGN: Consultancy, Research Funding, Speakers Bureau; Juno: Consultancy, Research Funding. Giafis:Pharmacyclics, an AbbVie Company: Employment, Other: Travel; AbbVie: Equity Ownership. Ipe:AbbVie: Equity Ownership; Pharmacyclics, an AbbVie Company: Employment, Other: Travel. Upasani:AbbVie (self and immediate family member): Equity Ownership; Pharmacyclics, an AbbVie Company (self and immediate family member): Employment. Sundaram:AbbVie: Employment, Equity Ownership, Other: Travel; Johnson & Johnson: Employment, Equity Ownership, Other: Travel. Ferrante:Janssen: Employment, Equity Ownership. Amaya-Chanaga:AbbVie: Equity Ownership, Other: Research performed while employed as an investigator of this study at UCSD. Review and approval of abstract performed while employed at Pharmacyclics, LLC, an AbbVie Company.; Pharmacyclics, an AbbVie Company: Employment, Other: Research performed while employed as an investigator of this study at UCSD. Review and approval of abstract performed while employed at Pharmacyclics, LLC, an AbbVie Company.. Iyengar:AbbVie: Equity Ownership; Pharmacyclics, an AbbVie company: Employment; Express Scripts: Patents & Royalties. Mato:Pharmacyclics, an AbbVie Company: Consultancy, Research Funding; AstraZeneca: Consultancy; Portola: Research Funding; Johnson & Johnson: Consultancy; Acerta: Research Funding; AbbVie: Consultancy, Research Funding; Prime Oncology: Honoraria; Celgene: Consultancy; Regeneron: Research Funding; Medscape: Honoraria; TG Therapeutics: Consultancy, Research Funding.

Background: Preference-based measures of health (PBMH) provide 'preference' or 'utility' weights that enable the calculation of QALYs for the economic evaluations of interventions. The Diabetes Utility Index (DUI) was developed as a brief, self-administered, diabetes mellitus-specific PBMH that can efficiently estimate patient-derived health state utilities. Objective: To describe the development of the valuation function for the DUI, and to report the validation results of the valuation function. Methods: Multi-Attribute Utility Theory (MAUT) was used as the framework to develop a valuation function for the DUI. Twenty of 768 possible health states of the DUI classified as anchor states, single-attribute level states including corner states, and marker states were selected and described for preference elicitation interviews. Visual analogue scale and standard gamble (SG) exercises were used to measure preferences from individuals with diabetes recruited from primary care and community settings in and around Morgantown, WV, USA for the 20 health states defined by combinations of DUI attributes and severity levels. Data collected in the interviews were used to develop a valuation function that calculates utilities for the DUI health states and calculates attribute-level utilities. A validation survey of the valuation function was conducted in collaboration with the West Virginia University (WVU) Diabetes Institute. Results: A total of 100 individuals with diabetes were interviewed and their preferences for various DUI health states measured. From data generated in the interviews, a DUI valuation function was developed on a scale where 1.00 - perfect health (PH) and 0.00 - the all worse 'pits' state, and adjusted to yield utilities on the conventional scale 1.00 - PH and 0.00 - dead. A total of 396 patients with diabetes who received care at WVU clinics completed a DUI mail validation survey (response rate - 33%). Clinical data consisting of International Classification of Diseases, 9th edition, diagnosis codes and glycosylated haemoglobin (HbA1c) values for the respondents were merged with their responses to the DUI. The utilities calculated by the scoring function of the DUI compared favourably to cardinal SG utilities for three DUI health states for which both assessments were available. The DUI utility function slightly underestimated actual SG utilities for mild and moderate health states (mean absolute difference - 0.05). There was a small but significant correlation between DUI utility scores and average past year HbA1c values (r - -0.30; p < 0.001). Respondents with two or more complications had significantly lower DUI utilities than those with no complications (p < 0.001) or one complication (p - 0.015). Insulin users had significantly lower DUI utilities than non-users (p < 0.001), and those with HbA1c values

Background Determining treatment response for patients with hidradenitis suppurativa (HS) can be challenging due to limitations of current disease activity evaluations. Objective Evaluate the novel, validated endpoint, Hidradenitis Suppurativa Clinical Response (HiSCR) and its utility as an outcome measure. Methods Patients with baseline total abscess and inflammatory nodule count (AN count) of at least three and draining fistula count of 20 or fewer comprised the post hoc subpopulation analysed. HiSCR (at least a 50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline) and HS-PGA Response [Hidradenitis Suppurativa-Physician's Global Assessment score of clear, minimal, or mild, with at least a 2-grade improvement from baseline] were used to evaluate patient response after adalimumab treatment weekly, every other week, or placebo (1 : 1 : 1). Results The subpopulation included 132 (85.7%) patients; 70.5% women and 73.5% white. At week 16, HiSCR was achieved by 54.5% receiving weekly adalimumab, 33.3% every other week, and 25.6% placebo and HS-PGA Response was achieved by 20.5% receiving weekly adalimumab, 6.7% every other week and 2.3% placebo. Conclusion HiSCR was more responsive to change than HS-PGA Response in this subpopulation.

Up to 11% of chondrosarcomas may undergo regional anaplastic change, resulting in a high-grade noncartilaginous sarcoma arising within a typically low-grade chondrosarcoma. Known as dedifferentiated chondrosarcomas, these tumors are highly malignant with a very poor prognosis. The most important factor affecting survival is an accurate preoperative diagnosis. Therefore, the ability to predict the possibility of dedifferentiation in a malignant cartilage tumor on the basis of imaging findings is critical to ensure adequate tumor sampling at the time of biopsy. Imaging findings at radiography, computed tomography (CT), and magnetic resonance (MR) imaging in 174 patients with dedifferentiated chondrosarcoma were reviewed to determine whether there are radiologic features that can help predict dedifferentiation. On approximately one-third of the radiographs, one-third of the MR images, and one-half of the CT scans, the tumors demonstrated bimorphic features (ie, distinctly different tumor features juxtaposed within the lesion), most frequently a dominant lytic area adjacent to a mineralized tumor at radiography and a large, unmineralized soft-tissue mass associated with an intraosseous chondroid-containing tumor at CT and MR imaging. In the initial evaluation of patients with a primary bone tumor, thorough evaluation of the radiologic features of the entire tumor is critical.

Contains fulltext : 153488.pdf (Publisher’s version ) (Open Access) BACKGROUND: Published evaluations of skin disease signs and health-related quality of life (HRQoL) upon therapy withdrawal and retreatment in psoriatic patients are limited to results of drug withdrawal after short-term treatment. Analyses are lacking that evaluate patients' response to retreatment for patients treated successfully long-term. OBJECTIVE: To study the efficacy and safety of adalimumab in patients with long-term clinical responses to adalimumab who then discontinue therapy and are retreated with the same dosing regimen as the initial course. Skin disease signs and patients' HRQoL are evaluated. METHODS: This post hoc analysis of an open-label study (NCT00195676) included patients who had responded favourably to adalimumab during initial treatment (>/=75% improvement in Psoriasis Area and Severity Index [PASI 75 response]) and had maintained good clinical response for an extended period (up to 252 weeks); patients had Physician's Global Assessment (PGA) 0 or 1 before treatment interruption. Following drug withdrawal (up to 40 weeks), all patients were retreated with adalimumab 80 mg initial dose, followed by 40 mg every-other-week for 16 weeks. PASI response and HRQoL were evaluated. RESULTS: Of the 133 patients in this analysis, 24 (18%) relapsed during therapy withdrawal. After 16 weeks of retreatment, 75% who relapsed and 89.9% who did not relapse, had a PASI 75 response; 89.5% achieved European Consensus Programme treatment goals after 16 weeks of retreatment. During drug withdrawal, HRQoL disproportionally worsened compared to skin disease signs; HROoL also considerably worsened for patients who did not relapse. Patients regained HRQoL upon retreatment with adalimumab. No new safety signals were identified in this study. CONCLUSION: Retreatment with adalimumab was successful in improving psoriasis skin signs and HRQoL in this subgroup with initial and extended responses to therapy followed by relapse after treatment withdrawal. Patient's HRQoL should be considered, as it may substantially worsen during therapy interruption.

The radiologist and orthopedic surgeon have a wide array of imaging modalities to choose from in diagnosing and staging solitary tumors of bone. MR imaging is the examination of choice for staging solitary tumors of bone. The radiograph, however, remains the most reliable imaging modality for predicting tumor histology. Radiographic interpretation in most instances ought to be the most influential factor in determining whether further imaging is required. This article reviews the strengths and weaknesses of the various imaging modalities and attempts to present a logical, cohesive, reproducible approach to the diagnosis and evaluation of solitary tumors of bone.

Background and objectives: Health-related quality of life (HR-QOL) and quality of life (QOL) are increasingly being examined as outcomes in assessments among patients with type 2 diabetes mellitus. However, there is a lack of standardization in interpreting the two outcomes and insufficient appreciation of the differences between HR-QOL and QOL. This study reports relationships between two instruments of HR-QOL and an instrument of QOL in a cross-sectional study of patients with type 2 diabetes. Abstract: Methods: Patients with type 2 diabetes at the outpatient clinics of a university hospital completed measures of generic health status (12-item Short-Form Health Survey &lsqb;SF-12&rsqb;, version 2 and EQ-5D) and diabetes-specific QOL (Audit of Diabetes Dependent Quality of Life &lsqb;ADDQoL&rsqb;). Patient-reported data were merged with retrospective clinical data including glycosylated hemoglobin (HbA1c), co-morbidities, diabetes complications score, body mass index (BMI), and others, obtained from electronic medical records. A path model of our hypothesized relationships between the physical and psychological components of HR-QOL, overall HR-QOL, and QOL was tested in addition to examining bivariate correlations between these constructs. The fit of the path model was assessed using multiple indexes of fit, including an overall chi-squared (χ) test, the Comparative Fit Index (CFI), the Tucker-Lewis Index (TLI), and the Root Mean Square Error Approximation (RMSEA). The differences in the association between clinical, medical history and sociodemographic variables with HR-QOL and QOL were explored employing univariate t-tests and ANOVAs as well as multiple regression models. Abstract: Results: The usable response rate was 44.3% (n - 385). The mean HbA1c of respondents was 7.2% (±1.4), mean duration of diabetes was 10.2 (±9.1) years, and 62.1% were obese (BMI ≥30 kg/m). About 49% of respondents were taking oral medications only, 31.7% were taking oral medications and insulin, and 9.4% were taking insulin only. Spearman correlations of the EQ-5Dindex were 0.640 with the SF Physical Component Score (PCS)-12, 0.534 with the SF Mental Component Score (MCS)-12, and 0.316 with the ADDQoL (all p < 0.001). A path analytic model relating SF-12 scores with EQ-5Dindex and ADDQoL scores exhibited good fit (χ - 1.32; p - 0.250; CFI - 0.99; TLI - 0.99; RMSEA - 0.03). Insulin use and diabetes-related complications were significantly associated with poorer scores on all measures. Only ADDQoL scores were significantly better among those with the American Diabetes Association-recommended HbA1c level of

This editorial and the “Perspective” on scientific journals and impact factors by W. Hendee, Bernstein, and Levine are the outcome of the Annual Editors’ Forum, which was hosted by the Imaging Institute of the Cleveland Clinic on August 20, 2011. In attendance at the forum were editors from Europe, Canada, and the United States representing 13 scientific journals concerned with medical imaging. One of the items on the agenda was the influence of the Impact Factor (IF) on the make-up of the journal. In our view, as lucidly outlined by Hendee et al., the IF has been brandished out of proportion as a signal of a journal’s worthiness. The IF is a metric that measures the citations of a journal’s articles over a 2-year period. The ranking of a journal is based on the 2-year IF. One of us (J.H.) gave a presentation on the influence of the IF on European radiology departments. Based on responses to a questionnaire survey, Hodler reported that promotions committees placed more emphasis on work published in journals with higher IFs and that a rise in a journal’s IF could influence the probability that a work would be submitted to Skeletal Radiology. To evaluate this position, we would like to share with you some metrics as they pertain to Skeletal Radiology with regard to citations, impact factor rank, and time. Based upon the 2-year IF, Skeletal Radiology is ranked 70 of 111 imaging journals. However, it ranks 38th based on the number of citations and 10th based on the cited half-life of articles, which is 8.8 years. These facts require interpretation. In a fast moving scientific field, it is probable that citations within 2 years capture the importance of an article. However, in our field, because of the relative rarity of the conditions, knowledge grows by the gradual accretion of information over a much longer time. In recognition of this, the journal has had a dedicated case report section since its inception. Case reports can be a sacrificial lamb on the altar of the IF because by their nature, they represent rarities, unlikely to be cited promptly after publication. It is often assumed that the higher the IF, the better the science. This is certainly an oversimplification. In their “Perspective” article, Hendee et al. have shown how the IF can be manipulated. To this we would add that the number of citations is merely an indicator of the degree to which a topic is “au courant”, not the accuracy or value of a paper. Completely false papers may receive a large number of citations as others debunk them. Scientific validity is a test of time and not a 2-year citation count. For these reasons and because of the narrowness of what it measures, we believe that the IF is of limited value for a journal such as Skeletal Radiology. The quality of a publication can not be evaluated based upon the IF of the journal in which it is published. M. Sundaram (*) The Cleveland Clinic Foundation, Cleveland, OH, USA e-mail: sundarm@ccf.org

BACKGROUND: Chest computed tomography (CT) screening of patients with blunt trauma for thoracic aortic injury is controversial. This study was undertaken to determine whether CT could exclude aortic injury and be used to select patients for aortography. METHODS: Computed tomography and aortography were used to evaluate 155 patients with blunt trauma. Computed tomography scans were reviewed separately by four attending radiologists who were unaware of the patients' clinical course and angiographic findings. RESULTS: Eight of 155 patients had aortic injuries requiring operation. Computed tomography scans in five patients were read as positive by all reviewers. One scan was read as positive by three reviewers and as negative by one. Two scans were read as positive by two radiologists and as negative by two. After poor scans were excluded, the combined sensitivity of CT for detecting aortic injury was 88%, specificity was 54%, positive predictive value was 9%, and negative predictive value 99%. CONCLUSIONS: The sensitivity of CT scan for indicating the need for aortography is observer dependent. As CT manifestations of aortic injury are often subtle, CT does not reliably exclude aortic injury.

The clinical presentation of bone and soft-tissue sarcomas is varied. Constitutional symptoms are rare, and although bone sarcomas tend to be painful while soft-tissue sarcomas usually are not, there are exceptions to this general rule. A high index of suspicion is required for any unexplained mass with indeterminate imaging findings. Choosing the right imaging modality is critical to the diagnosis and management of patients with suspected sarcoma, and referring clinicians have a multitude of imaging options. After discovery of a malignant-appearing bone lesion by radiography, further imaging is obtained for better characterization of the lesion (typically with magnetic resonance imaging [MRI]) and for staging (typically with computed tomography of the chest). In contrast, radiographs are rarely helpful for evaluation of soft-tissue lesions, which almost always require MRI assessment.

The patient and clinicians were concerned about the right lower extremity when in fact MRI showed the diseased extremity to be the left. The MR images (Figs. 1 and 2) show loss of subcutaneous fat throughout the left lower extremity with relative sparing of the muscle mass and medial thigh subcutaneous fat, accounting for the asymmetric size of the lower extremities and the misleading clinical appearance of an abnormally enlarged right lower extremity. The MRI distribution of subcutaneous fat loss of the left extremity was felt to be consistent with the diagnosis of lipodystrophy and in this patient attributed to adult onset dermatomyositis, which has been previously associated with lipodystrophy [1–3]. In addition, increased T2 signal on the STIR sequence within the subcutaneous tissues, particularly overlying the lateral left leg are indicative of active disease. Lipodystrophies are a group of disorders characterized by the loss of adipose tissue from various parts of the body, and have been categorized as being congenital or acquired and further subcategorized as generalized, partial, or localized [4]. The generalized varieties include congenital generalized lipodystrophy (Berardinelli–Seip syndrome) and acquired generalized lipodystrophy. Berardinelli–Seip syndrome is a rare autosomal recessive disorder in which there is a complete absence of adipose tissue at birth, while acquired generalized lipodystrophy manifests in late childhood and adolescence. Partial lipodystrophies include familial partial lipodystrophy (Dunnigan variety), which presents at onset of puberty, and acquired forms, which have been linked to HIV, drug use, and various autoimmune diseases. Localized forms of lipodystrophy are most often related to trauma, drug use, and autoimmune causes [4]. Patients affected by lipodystrophy are predisposed to insulin resistance. The central cause of morbidity and mortality in patients with lipodystrophy are diabetes mellitus and its long-term complications, including recurrent pancreatitis related to hypertriglyceridemia, chronic liver disease related to hepatic steatosis, and atherosclerotic disease [5]. Acquired lipodystrophies are the most common subtype, with HIV lipodystrophy accounting for over 100,000 cases of lipodystrophy in the United States alone [5]. The typical pattern of HIV lipodystrophy is loss of subcutaneous fat in the face and extremities, with compensatory circumferential adipose deposition in the submental (double chin), dorsocervical spine (buffalo hump), chest, and intra-abdominal regions [6]. This is in contradistinction to acquired partial lipodystrophy (Barraquer–Simons syndrome) and acquired generalized partial lipodystrophy. Acquired partial lipodystrophy is very rare (250 cases in the English literature), and characterized by subcutaneous adipose loss involving the face, neck, arms, chest, and abdomen, with compensatory circumferential adipose deposition in the thighs and lower legs [5]. Acquired generalized lipodystrophy (80 reported cases in the English literature) is characterized by circumThe case question and presentation can be found at doi:10.1007/ s00256-011-1271-7.

The differential diagnosis of cellulitis includes haematoma. This can be the presentation of a bleeding disorder in adult life.