Value Propositions - June 2016

VBCR - June 2016, Vol 5, No 3 - Value Propositions

In This Article

Tocilizumab Effective, Highly Retentive in Patients with Rheumatoid Arthritis

According to the results of a recent, 2-year efficacy study, tocilizumab is effective when used as monotherapy or in combination with synthetic disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis. Use of the drug has also demonstrated high rates of retention.

Researchers evaluating the efficacy, retention rates, and predictors of response of tocilizumab in patients with rheumatoid arthritis conducted a prospective, longitudinal, open-label study in patients receiving tocilizumab 8 mg/kg every 4 weeks in a clinical practice setting. They used European League Against Rheumatism (EULAR) response criteria to evaluate clinical responses, and also measured low activity and remission rates in accordance with the Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAI).

According to the results, and following 6 months of treatment, the EULAR response rate was 86.63% and the DAS28 remission rate was 53.7%. At month 24, rates of low disease activity were 52.9% and 47.1% on CDAI and DAS28, respectively.

No statistically significant differences were observed in the EULAR response rates of low activity and remission on DAS28 between patients receiving tocilizumab monotherapy and as combination therapy, or between patients positive or negative for rheumatoid factor/anti–cyclic citrullinated peptide antibodies.

Remission and low activity rates after 6 months of treatment were better in patients who were naïve to biologic therapy, and, at month 24, the retention rate was 61%. Adverse events were among the most common reasons for treatment discontinuation.

“Tocilizumab is effective in [rheumatoid arthritis], has a similar efficacy when used alone or in combination with synthetic DMARDs and shows high retention rates,” the study authors reported.

Notario Ferreira I, Ferrer González MA, Morales Garrido P, et al. Reumatol Clin. 2016 May 9. Epub ahead of print.

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Cardiovascular Screening Cost-Effective in Patients with Rheumatoid Arthritis

Not only does early detection and preemptive treatment play a significant role in reducing excess risk for cardiovascular disease in patients with rheumatoid arthritis, but it is also cost-effective, according to new data.

Using a Markov chain model, a time frame of 10 years, and a variety of scenarios based on different guidelines, Wietske Kievit, PhD, Department of Health Evidence, Radboud University Nijmegen Medical Centre, The Netherlands, and colleagues assessed whether cardiovascular screening is medically cost-effective in this patient population.

Limiting values were obtained primarily from the literature and from patients with rheumatoid arthritis screened for cardiovascular diseases at the Radboud University Nijmegen Medical Centre. Conveyed as costs per quality-adjusted life-year (QALY) gained, the primary outcome measure was incremental cost-effectiveness. Multiple scenarios were devised, and probabilistic sensitivity analysis—which was described using willingness-to-pay curves—was performed.

In 82% of the base-case scenario simulations, screening was more common than no screening. There was a 0.09 mean QALY gain and approximately $1100 in mean cost-savings. Throughout the various scenario simulations, small differences in cost-effectiveness were demonstrated. The study authors also noted that the probability of screenings being more common than no screenings stayed high, with the lowest probability being 50% in a very conservative scenario.

“Screening for cardiovascular events in [rheumatoid arthritis] patients was estimated to be cost-effective with high chances of being less expensive and more effective,” Dr Kievit and colleagues concluded. “These results support endorsement of screening for CV risk in patients with [rheumatoid arthritis].

Kievit W, Maurits JS, Arts EE, et al. Arthritis Care Res (Hoboken). 2016 May 9. Epub ahead of print.

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Decernotinib, DMARD Combination Reduces Symptoms, Signs of Rheumatoid Arthritis

Patients with rheumatoid arthritis and an inadequate response to disease-modifying antirheumatic drug (DMARD) monotherapy may experience a reduction in signs and symptoms of their condition when given decernotinib (VX-509) in combination with stable DMARD therapy, researchers found.

Seeking to examine the early effects of the decernotinib and DMARD combination on joint structures in adults with rheumatoid arthritis, Mark C. Genovese, MD, Professor, Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, and colleagues conducted a randomized, placebo-controlled, double-blind, dose-ranging study of patients with rheumatoid arthritis and inadequate DMARD response.

Measured outcomes included the rheumatoid arthritis magnetic resonance imaging scoring (RAMRIS) system, American College of Rheumatology scores (ACR20; improvement of ≥20%), and Disease Activity Score 28 (DAS28) using C-reactive protein (CRP). Patients in the study were administered decernotinib 100 mg, 200 mg, or 300 mg, or placebo once daily for 12 weeks.

At 12 weeks, the study authors observed an ACR20 response of 63.6%, 60.0%, and 60.0% in the decernotinib 100-mg, 200-mg, and 300-mg groups, respectively, versus 25.0% in the placebo group. Significant differences were noted between the RAMRIS synovitis scores of the placebo group and all decernotinib dose groups (P <.01), and between the RAMRIS osteitis scores of the placebo and decernotinib 300-mg groups (P <.01). With increasing decernotinib doses, DAS28-CRP scores decreased in a dose-dependent manner.

Genovese MC, Yang F, Østergaard M, Kinnman N. Ann Rheum Dis. 2016 Apr 15. Epub ahead of print.

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Efficacy of Etanercept, Methotrexate Combination Independent of Methotrexate Dosage

Regardless of the methotrexate dosage, etanercept and methotrexate combination therapy resulted in similar efficacy outcomes at 24 months among patients with rheumatoid arthritis.

“These findings suggest that lower doses of [methotrexate] can be considered in patients who do not tolerate [methotrexate], while maintaining clinical efficacy and [quality of life],” according to the authors.

In an effort to study the impact of methotrexate dosage on clinical, functional, and quality-of-life outcomes in patients with rheumatoid arthritis after 24 months of treatment, investigators conducted a post hoc analysis using data from the etanercept and methotrexate combination treatment arms of the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) and Combination of Methotrexate and Etanercept in Active Early Rheumatoid Arthritis (COMET) studies. Data were stratified by methotrexate dosage at 24 months (ie, low dose, <10.0 mg per week; medium dose, 10.0-17.5 mg per week; and high dose, >17.5 mg per week), and methotrexate monotherapy groups served as controls.

In addition to including descriptive summaries of demographic and disease characteristics of these subgroups at baseline, the study authors evaluated Disease Activity Score 28 (DAS28) low disease activity (LDA) and remission; American College of Rheumatology 20%, 50%, and 70% improvement criteria (ACR20, ACR50, and ACR70) responses; and changes from baseline in DAS28, Health Assessment Questionnaire Disease Index (HAQ-DI), and EuroQol 5-dimensions visual analog scale (EQ-5D VAS).

Aside from disease duration, baseline demographics were similar among the low-, medium-, and high-dose methotrexate groups in the etanercept and methotrexate combination and methotrexate monotherapy arms. At 24 months, and across all methotrexate dosage groups, responses to the etanercept and methotrexate combination therapy were consistently high; rates were very similar in DAS28 LDA and remission, and ACR20, ACR50, and ACR70. In addition, the researchers noted that DAS28, HAQ-DI, and EQ-5D VAS improvements in the combination treatment arm were not dependent on methotrexate dosage.

Gallo G, Brock F, Kerkmann U, et al. RMD Open. 2016;2:e000186.

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Last modified: July 12, 2016
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