Disease Activity in Biologic Naïve Rheumatoid Arthritis Patients Initiating Tnf Inhibitors

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Kulkhan T1, Sassykova A2, Mauyenova D, Yermakhanova G2 Research Institute on Gerontology, Astana, Kazakhstan, 2Republican Center for Health Development, Astana, Kazakhstan 1Scientific

Objectives: In structure of pathology of locomotor apparatus the inequality of lower limbs length in children is about 36%. Axial deformities of lower limbs leads to early development of arthroses, accompanied by violations of biomechanics of walk and spinal disorders. Traditional treatment methods do not always allow immediate eliminating of all deformity components. Also traditional methods are traumatic for patients, do not exclude recurrences. Temporary epiphysiodesis of growth plates is existing alternative method of treatment of difference in length of lower limbs and angular deformities of knee joints. This method is low-traumatic, minimally invasive medical interventions. Distinction of this method from other surgical interventions is the absence of solution of continuity of a bone. Authors evaluated clinical efficacy of temporary epiphysiodesis of long tubular bones growth plates using metal plates according to research available in the database of evidence-based medicine.  Methods: Review of the literature was conducted on the safety and efficacy of temporary epiphysiodesis of long tubular bones growth plates using metal plates in databases PubMED, Cochrane Library, NICE, Clinical Trials, TripDatabase according to research issues(PICOs) and key words.  Results: After literature review of 307 sources, relevant for PICOS-criteria reports were selected for the study, 14 of which were taken for final analysis. Remaining publications were excluded due to noncompliance with criteria of research questions.  Conclusions: Following performed systematic search publications, studying clinical efficacy and safety of temporary epiphysiodesis of long tubular bones growth plates in children with congenital abnormalities of tubular bones were found. In this case, there is minimum damage to surrounding soft tissues, risk of intraoperational complications is minor, as there are no any large anatomic formations in this area. The limited quantity of studies concerned with research of clinical efficacy of temporary epiphysiodesis of long tubular bones growth plates stemmed from ethical barriers in conducting studies in pediatric practice. PMS14 Efficacy, Safety, and Cost Effectiveness of Teriparatide for the Treatment of Osteoporosis Marra LP1, Almeida-Brasil CC1, Guerra-Júnior AA1, Almeida AM2, Lemos LL3 1College of Pharmacy, Federal University of Minas Gerais, Belo Horizonte, Brazil, 2College of Medical Sciences of Minas Gerais, Belo Horizonte, Brazil, 3CCATES, Federal University of Minas Gerais, Belo Horizonte, Brazil

Objectives: To evaluate the efficacy, safety and cost-effectiveness of teriparatide for osteoporosis treatment.  Methods: We conducted a search at the databases Cochrane, Medline, Lilacs and Centre for Reviews and Dissemination (CRD). Manual search was also conducted on the internet and in the references of the studies found. Health Technology Assessments (HTA) have been selected in international agencies and in Brazilian Network for Health Technology Assessment (REBRATS). Systematic reviews of randomized controlled trials (RCTs) and cost-effectiveness studies that evaluated the use of teriparatide compared to placebo or to alternatives available at SUS were eligible. The outcomes considered were bone density, risk of fractures, adverse events and incremental cost-effectiveness ratio (ICER).  Results: Six systematic reviews of efficacy and safety and two cost-effectiveness studies were included. All systematic reviews of efficacy and safety had reasonable quality and favored the use of teriparatide. Regarding the increase in bone mineral density (BMD), teriparatide was more effective than placebo, alendronate and conjugated estrogens in all studies that evaluated this outcome. In the reduction of fractures, considered as the clinically relevant endpoint, teriparatide was effective compared to placebo, alendronate, raloxifene and conjugated estrogens. Information on the safety of the technology was insufficient and there is evidence that treatment with high doses of PTH was associated with developing osteosarcoma. Regarding the cost-effectiveness, the included studies did not demonstrate clinical relevance in the outcomes assessed and teriparatide proved to be cost-effective only in comparison with bisphosphonates and only for patients with severe postmenopausal osteoporosis.  Conclusions: Evidences support the teriparatide use only for women with severe postmenopausal osteoporosis and therapeutic failure to alendronate, which is provided by SUS. It is important to highlight that teriparatide has a high cost compared to alternatives already incorporated and that other developed countries recommend the limited use of this technology. PMS15 Analysis of the Results Obtained when Treating Patients with Rheumatoid Arthritis with Biological Therapy in the Costa Rican Social Security System (Caja Costarricense De Seguro Social - Ccss) Ching Fung SM, Castro Cordero JA, Marin Piva H Caja Costarricense de Seguro Social, San Jose, Costa Rica

Objectives: Since 2011, CCSS offers treatment with biological therapy (BT) to the patients with Rheumatoid Arthritis (RA) refractory to treatment with conventional synthetic disease modifying drugs.This study aims to assess the effectiveness of the treatment with BT in patients with RA.  Methods: Applied observational study with a prescription-indication approach according to the standard methodology for drug utilization research. We used data from the central data base of drug prescriptions from CCSS between January 1st 2013 and April 30th 2014, and then obtained the following information from the medical records: birth date, gender, diagnosis, DAS28 value at the beginning of treatment, at 3, 6, 12 months and at the moment of the last medical evaluation, and response to therapy. Technological tool: Microsoft Excel®.  Results: 159 patients received prescription of biological therapy for RA: 101 (64%) Etanercept, 37 (23%) Adalimumab and 21 (13%) Tocilizumab. 144 (91%) continue treatment. 15 (9%) suspended treatment, 10 (67%) due to treatment failure, 3 (20%) didn’t continue BT, the other 12 (80%) switch to other agent. Average DAS28 at the beginning of treatment 5.5, (IC95%: 5.3 to 5.7) at 12 months 2.8 (IC95% 2.6 to 3.1) and at the last medical evaluation 2.7 (IC95% 2.5 to 2.9), without statistical significant difference between

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treatments; a tendency to lower values was observed with Tocilizumab. At the time of the last evaluation 56% of patients were in remission, 21% had mild activity, 19% had moderate activity and 5% severe activity. All patients with severe activity suspended treatment, and 16% of patients with moderate activity did. Average treatment time 3.7 years.  Conclusions: Treatment of RA with biological therapy in CCSS has been effective in a majority of patients, without differences between therapies with a tendency to better response with Tocilizumab that should be evaluated in a future. PMS16 Disease Activity in Biologic Naïve Rheumatoid Arthritis Patients Initiating Tnf Inhibitors Harrold L1, Larmore C2, Boytsov N2, Reed G3, Mason M3, Gaich CL2, Zhang X2, Rebello S3, Araujo AB2 of Massachusetts, Worcester, MA, USA, 2Eli Lilly and Company, Indianapolis, MA, USA, 3Corrona, LLC, Southborough, MA, USA

1University

Objectives: With availability of biologic agents, remission is a realistic goal for many rheumatoid arthritis (RA) patients. We characterized patterns of disease activity among patients receiving TNF-inhibitors (TNFi) according to disease activity at TNFi treatment initiation.  Methods: Within the Corrona registry we identified RA patients previously treated with ≥ 1 conventional synthetic DMARD who initiated their first TNFi and had at least 1 year of follow-up. We excluded patients with age of RA onset < 18, comorbid psoriasis/psoriatic arthritis, fibromyalgia or osteoarthritis. Disease activity was assessed using Clinical Disease Activity Index (CDAI) while on TNFi therapy. We examined the lowest level of disease activity across all visits through 1-year while on TNFi therapy.  Results: 1931 patients met inclusion criteria between 1/1/2006 and 8/ 31/2014. Most patients were female (75%), white (87%) and middle aged (mean 56 years [SD= 12]). CDAI at index visit identified 207 (11%) patients in remission, 461 (24%) in low disease activity (LDA) and 1263 (65%) in moderate/high disease activity (M/HDA). Among patients in M/HDA at index, 10% had remission on 2 consecutive follow-up visits, 15% had remission at least once, 15% had LDA on 2 consecutive visits, and 20% had LDA at least once. Of the 512 (41%) patients who remained in M/HDA during follow-up, 252 (49%) switched biologics (27% to TNFi [mean 8 months (SD= 3)] and 73% to a non-TNFi [mean 5 months (SD= 2)] biologics), and 258 (50%) stayed on the initial TNFi.  Conclusions: Many biologic naïve RA patients initiating their TNFi in M/HDA failed to achieve remission or LDA during 1-year period while remaining on TNFi therapy. Half of these patients remained on the initial TNFi. Further investigation is needed to examine whether this is due to a lack of treat to target approach to care or barriers to aggressively manage patients. PMS17 Utilization of Tumor Necrosis Factor Alpha Inhibitors in Children and Young Adults with Juvenile Idiopathic Arthritis Lee W1, Briars LA1, Lee TA1, Calip GS1, Suda KJ2, Schumock G1 of Illinois at Chicago, Chicago, IL, USA, 2Department of Veterans Affairs and University of Illinois at Chicago, Hines, IL, USA

1University

Objectives: To characterize the utilization of tumor necrosis factor-alpha inhibitors (TNFI) in children with juvenile idiopathic arthritis (JIA) and young adults with rheumatoid arthritis (RA).  Methods: Patients with incident JIA or RA were identified using healthcare claims data from 2009 to 2013. TNFI utilization patterns were examined, including switching among TNFIs, adherence, persistence, and time from diagnosis to TNFI use. Earlier TNFI treatment without prior use of traditional disease-modifying antirheumatic drugs (DMARD) and use of specific TNFIs were analyzed by age group.  Results: Among 6,962 children and young adults with new diagnoses of JIA/RA, 43.5% were treated with DMARDs and 18.6% were treated with TNFIs. In these TNFI users, 39.1% received earlier TNFI therapy without prior use of DMARDs. Patients diagnosed in more recent years (2012 to 2013) had a higher instantaneous rate of receiving a TNFI (hazard ratio 1.13, 95%CI 1.00-1.28, p= 0.044) than those in year 2009 to 2011. Etanercept was the most commonly used, especially by children aged < 12 (75.5%) and adolescents aged 12 to 17 (62.5%), while adalimumab was more commonly prescribed for young adults aged 18-24 (35.0%) compared to children (16.4%) and adolescents (27.8%). Adherence measured as mean proportion of days covered ranged from 70.4% to 93.2% for individual TNFI agents. Only about 60% of patients continuously took TNFIs for 12 months. When switching occurred, switching from etanercept to adalimumab was the most common pattern.  Conclusions: Earlier TNFI therapy was observed in 39.1% of children and young adults taking TNFIs. In addition, the time to first TNFI prescription became shorter over the study period. Future research should evaluate the long-term effectiveness and safety of this more aggressive TNFI therapy. PMS18 The Association Between Serum Uric Acid Levels and Acute Myocardial Infarction in Incident Gout Patients Cheetham TC1, Nichols GA2, Harrold L3, Schmidt MA2, Reifler LM4, Tabano D4, Raebel MA4 1Kaiser Permanente Southern California, Pasadena, CA, USA, 2Kaiser Permanente Northwest, Portland, OR, USA, 3University of Massachusetts School of Medicine, Worcester, MA, USA, 4Kaiser Permanente Colorado, Denver, CO, USA

Objectives: To determine the association between elevated sUA levels and AMI’s in a population of incident gout patients. Gout has been associated with an increased risk of acute myocardial infarction (AMI), however, less data are available evaluating the relationship between sUA serum levels and AMI’s.  Methods: A retrospective cohort study was undertaken using data from an integrated healthcare delivery system. Patients needed to be 18 years or older and have a gout diagnosis between January 2001 and December 2010; the first diagnosis in this time period was defined as the index date. Follow-up continued through December 2013. Incident patients had no gout diagnoses or urate lowering therapy for two years prior to the index date. The outcome of interest was a hospitalized, non-fatal AMI. Data were collected on demographics and a standard set of cardiovascular risk factors. Patients were followed until they had an AMI, death, termination of enrollment or end of