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Recent advances have increased treatment options for, and improved clinical outcomes in, metastatic melanoma (mM). Using a large claims database, this retrospective study compared healthcare and adverse event (AE) costs in a US managed care population of mM patients initiating vemurafenib (VEM), ipilimumab (IPI), dacarbazine (DTIC), paclitaxel (PAC), or temozolomide (TMZ) from July 2009 to September 2012. Treatment episodes were identified from the start of study drugs (index date) to a switch to a different study drug, or a gap greater than 45 days (>112 days for IPI). Grade 3/4 adverse events occurring ≥5% from study drug package inserts were selected for this analysis. All-cause costs for treatment episodes and AEs were normalized as monthly costs. Generalized estimating equation models with log link and gamma distribution provided adjusted monthly treatment episode and AE costs. A total of 809 treatment episodes were identified in 541 mM patients, with a mean (SD) age of 57.5 (11.5) years. The total mean (SD) all-cause cost per treatment episode for VEM was $77 687 ($60 329), for IPI was $153 062 ($134 048), for DTIC was $35 243 ($33 641), for TMZ was $42 870 ($41 384), and for PAC was $58 991 ($81 306). The adjusted mean monthly treatment episode cost for VEM was significantly lower than that for IPI and comparable to that for other drugs. VEM had a significantly lower monthly AE cost than IPI, DTIC, and PAC. In combination with safety and efficacy findings, these results may assist clinicians, patients, policy makers, and payers in the treatment of mM.

Although hypogonadism (HG) is interrelated with type 2 diabetes mellitus (T2DM), there is little information about men's experiences with HG, T2DM, and testosterone replacement therapy (TRT). We examined symptoms and TRT use among men with HG, with and without T2DM, who received care within a single United States health plan.Men aged ≥ 18 years with HG, with and without T2DM, were identified from the 2008 to 2010 Reliant Medical Group electronic medical record database. Surveys responses compared by T2DM status using chi-square or Wilcoxon rank sum tests.A total of 93 men were included (19 with HG and T2DM, 74 with HG only). Men with both HG and T2DM were more frequently treated for their HG by an endocrinologist (52.6%), compared with men with HG only (28.4%, p = 0.058). Erectile dysfunction (ED) was the primary reason for seeking care among all surveyed men, although men with HG and T2DM reported experiencing ED more often (94.7%) than men with HG only (46.0%, p0.0001). Additional reasons for seeking care were similar between cohorts and included loss of energy and decreased sex drive. Most men (88.2%) reported using TRT, primarily as injection or gel formulations. Discontinuation of TRT was reported slightly more frequently by men with HG and T2DM (68.4%), compared with men with HG only (55.4%, p0.05).This study provides information about symptoms and TRT utilisation among HG men with and without T2DM. Men with HG only were less likely than those with both HG and T2DM to report that they were currently experiencing key symptoms compared with when they were first diagnosed, regardless of TRT utilisation, and were less likely to report ED as a current symptom.

Aims: Real-world evidence on the safety profile and costs associated with immune thrombocytopenic purpura (ITP) treatment in adults is lacking. This study quantifies and compares adverse event (AE) crude rates and costs associated with ITP treatments as found in claims data. Materials and methods: A retrospective claims-based analysis was conducted using IMS Pharmetrics Plus database. Included patients were ≥18 years old, with a diagnosis of ITP (2007–2012); an ITP-related claim for anti-D, intravenous immunoglobulin (IVIG), rituximab, romiplostim, or eltrombopag; and 1-year continuous enrollment (3-years for rituximab) during follow-up. AEs and event costs were identified during active treatment, defined from the first claim of each drug to a pre-defined treatment gap or end of study period. Descriptive statistics were reported with Wilcoxon rank-sum significance tests. Results: A total of 2,518 patients were identified (mean age = 50.8 (±16.3 years); 55.8% male). Of all patients, 22.8% experienced any AE. Significantly fewer anti-D patients had any AE (13.8% vs IVIG: 21.1%, rituximab: 29.4%, romiplostim: 28.1%, eltrombopag: 22.4%). Nausea/vomiting and arthralgia/musculoskeletal pain were most common across treatments, and hemolytic events did not differ significantly across treatments. Most costly AEs were urinary tract infection, aseptic meningitis, and fever ($5000+/case); headache, nasal congestion, and hemolytic event were $4,000–5,000/case. Cost per AE did not differ by treatment. Limitations and conclusions: Although lower than trial-based AE rates, claims for ITP treatment-related AEs are common, with higher numbers for rituximab and lower numbers for anti-D. This disparity suggests a possible differential cost burden overall that future analysis should explore.

Medication adherence and persistence patterns among patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) were analyzed. Electronic medical records of patients from the Reliant Medical Group were examined to evaluate adherence and persistence patterns. A total of 1,807 patients with LUTS/BPH were included in the study, and the number of patients at least 50 years of age was 1,748/1,807 (97%). Overall, 15.77% of patients were prescribed index prescription once, and no patients on combination alpha-blocker and 5-alpha reductase inhibitor therapies were prescribed their index prescriptions once. For all patients with LUTS/BPH, the mean number of prescriptions filled was 6.26, and the percentage of men persisting on index therapy for ≥4 years was 48%. Patients with LUTS/BPH showed a high proportion of both adherent and persistent treatment patterns, especially among patients taking combination therapy. The long follow-up time in our study provides evidence that patients are experiencing sufficient symptom relief to tolerate the challenges of remaining adherent and persistent.

Patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are frequently treated with subcutaneous biologic therapies when disease progresses or when response to synthetic disease-modifying antirheumatic drugs (DMARDs) is inadequate. This study analyzed treatment persistence and treatment patterns for RA, AS, and PsA patients in Germany initiating subcutaneous biologic therapies with and without prior DMARDs use. A retrospective cohort study was conducted using the Electronic Medical Record database of IMS Disease Analyzer, Germany. Patients who were ≥18 years old; had at least one ICD-10 diagnosis code of RA, AS, or PsA during the study period; and had exposure to a subcutaneous biologic agent between January 1, 2009 and June 30, 2012 were selected. Patients were required to have continuous observation ≥12 months prior to and after index medication date. Persistence was defined as consecutive days from treatment initiation until treatment discontinuation (≥60-day lapse in medication coverage). Patients were stratified by pre-index use of DMARDs. Kaplan-Meier analysis was conducted to assess time to discontinuation, and logistic regression was conducted to identify characteristics associated with persistence. A total of 576 RA, 108 AS, and 197 PsA patients without biologic experience during the pre-index period were selected. The percentages of RA, AS, and PsA patients persistent ≥12 months were 51.9, 48.1, and 57.9 %, respectively. Median persistent time over 12 months was 365.0 days for RA (mean 245.9 days), 281.0 for AS (mean 228.5), and 365.0 for PsA (mean 264.1). In the RA cohort, a significantly higher proportion of those with pre-index DMARD use were persistent compared to those without pre-index DMARD (56.1 vs. 33.3 %, p = 0.0001). No significant differences were observed for the AS and PsA cohorts. Multivariate analyses confirmed that DMARD-experienced patients were 2.45 times more likely to be persistent with subcutaneous biologic therapy in the RA cohort. Switching between subcutaneous biologics occurred in

Summary Objective To examine self-reported experiences with hypogonadism (HG) and patterns of testosterone replacement therapy (TRT) in men seeking care in a U.S. healthcare system. Methods Men ≥ 18 years old with HG were identified from the 2008–2010 Reliant electronic medical records database. Surveys, including validated instruments for measuring symptoms of HG, were collected and evaluated for demographic and behavioural data. Results Surveys were mailed to 133 men with HG in 2012. Of the 107 surveys returned, 95 were included in the final analysis. Most respondents were Caucasian (90.5%). Men reported developing symptoms of HG, as well as being diagnosed, at a median age of 50 years. The most common symptoms reported as reasons for seeking treatment were erectile dysfunction (66.3%), fatigue (59.0%) and decreased sex drive (57.9%). These continued to be the most bothersome symptoms at the time of the survey regardless of whether the patient received treatment, although men who were currently taking TRT reported less severe symptoms. Approximately 88% of men reported taking TRT at some point, with 61.9% on therapy at the time of the survey. Conclusions This study examined men's experiences with HG, including symptoms, quality of life, and treatments. Some symptoms continued despite treatment, and therapy was discontinued at a high rate, which men generally attributed to cost and perceptions of efficacy. In light of this lack of adherence, patients may benefit from appropriate expectation setting regarding reasonable timelines for symptom improvement, the strengths and challenges of various TRT formulations, the importance of adherence and the benefits and risks of TRT.

Background Ankylosing Spondylitis (AS) is a chronic, systemic disease that predominantly affects the axial skeleton with sacroiliac joints involvement as its hallmark, causing characteristic inflammatory back pain and resulting in varying degree of structural and functional impairments. Subcutaneous biologic therapies are usually prescribed to patients with active severe AS, who have responded inadequately to conventional therapy. Objectives This study was conducted to describe treatment patterns including treatment persistence with subcutaneous biologics among newly treated AS patients over 12 months. Methods This was a retrospective analysis using IMS Disease Analyzer-Germany, an electronic medical records database. Adult (≥18 years of age) AS patients who had no biologic experience and initiated therapy with subcutaneous biologics between January 1, 2009 and June 30, 2012 were included in the analysis. The date of the first subcutaneous biologic prescription served as their index date. Continuous observation of at least 12 months pre- and post-index date was required. Patients who were prescribed any biologic (subcutaneous or intravenous) during the pre-index period or diagnosed with rheumatoid arthritis, psoriatic arthritis or other conditions treated with subcutaneous biologics either in pre- or post-index were excluded from the study population. Persistence with index subcutaneous biologic was defined as time from index subcutaneous biologic treatment initiation until index subcutaneous biologic treatment discontinuation (continuous ≥60-day lapse in medication coverage). Switching and dose escalation patterns of the index subcutaneous biologic agents were also assessed. Results The study cohort included a total of 108 AS patients who had no biologic experience. The mean (SD) age of the patients was 42 (12) years, with 70% of patients being male. The majority of patients (61%) indexed on adalimumab, while the remainder indexed on etanercept (28%) and golimumab (11%). NSAIDs/analgesics (67%) were the most commonly used medications in pre-index period, followed by corticosteroids (35%) and DMARDs or other immunosuppressive agents (23%). The most frequent comorbidities were osteoporosis (11%) and hypertension (7%). About 46% of AS patients persisted on their index subcutaneous biologics for at least 12 months. About 4% of the patients switched to other subcutaneous biologics during the follow-up period. Among patients persistent on their index subcutaneous biologic, 60% had dose escalation. Conclusions Forty-six percent of the AS patients remain on their initial subcutaneous biologic for at least 12 months in Germany. Switching between subcutaneous biologics in this cohort was uncommon. Dose escalation was common among persistent patients. Results of this study should be further explored using a larger population to identify factors that impact persistence. Disclosure of Interest M. Govoni Employee of: Merck Sharp & Dohme Limited, R. Lyu Employee of: Merck & Co. Inc, Q. Ding: None declared, T. Fan: None declared, A. Ogbonnaya Grant/research support: Merck & Co. Inc, P. Donga Grant/research support: Merck & Co. Inc, J. Korn Grant/research support: Merck & Co. Inc, C. Makin Grant/research support: Merck & Co. Inc DOI 10.1136/annrheumdis-2014-eular.3843

Background Subcutaneous biologic therapies are usually prescribed to patients with moderate to severe Rheumatoid Arthritis (RA), particularly in patients whose condition is not responding to conventional disease-modifying antirheumatic drugs (DMARDs). Objectives The objective of this study was to describe treatment persistence over 12 months for RA patients who were newly treated with subcutaneous biologics, and assess differences between patients with and without prior DMARDs experience. Methods A retrospective cohort study was conducted using the Electronic Medical Record database of IMS Disease Analyzer-Germany. Patients who were ≥18 years old, had at least one ICD-10 diagnosis code of RA during the study period, and had exposure to a subcutaneous biologic (certolizumab, etanercept, adalimumab, anakinra, or golimumab) between January 1, 2009 and June 30, 2012 were selected, with the first prescription date serving as the index date. Patients were required to have continuous observation for a minimum of 12 months prior to and after the index date. Patients with a prescription for any biologic (subcutaneous or intravenous) during the pre-index period, and/or those diagnosed with ankylosing spondilitis, psoriatic arthritis or other conditions treated with subcutaneous biologics either pre- or post-index were excluded from the study population. Persistence with any subcutaneous biologic agent was defined in consecutive days from treatment initiation until treatment discontinuation (continuous ≥60-day lapse in medication coverage). Patients were stratified into one of two mutually exclusive cohorts, based upon pre-index use (or lack thereof) of DMARDs. A chi-square test was used to measure the difference in the percentage of persistent patients and a logistic regression model was created to assess differences in the likelihood of being persistent, controlling for baseline demographic and clinical characteristics. Results A total of 576 RA patients without biologic experience during the pre-index period were selected, 471 with prior DMARDs use and 105 without. The mean (SD) age of the patients was 57 (13) years, with 75% being female. The most frequent comorbidities were hypertension (10%), osteoporosis (9%), and diabetes (6%). Majority of the patients were treated with etanercept (46%) and adalimumab (40%). Overall a mean of 246 days on subcutaneous biologic treatment over a period of 12 months was observed. About 52% of the patients persisted on any biologics for at least 12 months. A significantly higher percentage of patients with pre-index DMARDs were persistent (56% vs. 33%; p=0.0001), and after controlling for pre-index characteristics, patients with a pre-index DMARDs had 2.49 times the odds of being persistent compared to those without pre-index DMARDs use (OR: 2.49, 95% CI: 1.54-4.04). Conclusions More than half of the patients were persistent over 12 months after newly initiating their index subcutaneous biologic in Germany. Patients with pre-index DMARDs were significantly more likely to persist on biologic treatment than patients without pre-index DMARDs. Further investigation is needed to understand whether specific drugs have different persistence patterns. Disclosure of Interest R. Lyu Employee of: Merck & Co. Inc, M. Govoni Employee of: Merck Sharp & Dohme Limited, Q. Ding: None declared, T. Fan Employee of: Merck & Co. Inc, A. Ogbonnaya Grant/research support: Merck & Co. Inc, P. Donga Grant/research support: Merck & Co. Inc, J. Korn Grant/research support: Merck & Co. Inc, C. Makin Grant/research support: Merck & Co. Inc DOI 10.1136/annrheumdis-2014-eular.4656

9007 Background: Advances in mM have increased treatment (tx) options, where previously, few therapies were available. This study compares HC and adverse event (AE) costs in a U.S. managed care pop...

6582 Background: Prior real-world (RW) studies of advanced non-small cell lung cancer (adv NSCLC) have described overall survival (OS) from diagnosis (Dx) for all patients (pts) as well as separate...