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Indirect Treatment Comparison for Abatacept with Methotrexate Versus Other Recommended Biologic Agents in the Treatment of Patie

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Indirect Treatment Comparison for Abatacept with Methotrexate Versus Other Recommended Biologic Agents in the Treatment of Patie Indirect Treatment Comparison for Abatacept with Methotrexate versus other recommended Biologic Agents in the Treatment of Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy in the UK Maximilian Lebmeier 1, Louisa Pericleous 1, Peter Taylor 2, Robin Christensen 3, Pieter Drost 4, Patricia Guyot 5, Indra Eijgelshoven 5, Gert Bergman 5 1Bristol-Myers Squibb Pharmaceuticals Ltd, Uxbridge, Middlesex, United Kingdom, 2Imperial College London, London, United Kingdom,3The Parker Institute: Musculoskeletal Statistics Unit (MSU), Copenhagen, Copenhagen, Denmark, 4Bristol-Myers Squibb, Braine-l’Alleud, Belgium, 5Mapi Values, Houten, Netherlands Background Figure 1 – Study selection process Figure 5 – ACR response rates (relative risks): treatment effect relative to placebo Rheumatoid arthritis (RA) is a chronic, disabling, systemic Search strategy: inflammatory disorder with immune-mediated attacks of the synovial * 1980 – Jan 2010: Datastar (Embase, Medline, Medline in progress), Cochrane RCT Library * Jan 2010 – Oct 2010: Ovid (Embase, Medline, Medline in Progress), Cochrane RCT Library ACR20 ACR50 ACR70 joints. Retrieved from: Datastar, Ovid and Cochrane RCT Library: 1744 Adalimumab + MTX * Other sources: BMS CSR, Conferences 2008 – 2010: ACR and EULAR and NICE/STA submission ACR20: 2.49 (1.76;3.21) Abatacept, a selective co-stimulation modulator, inhibits the co- Retrieved from: Other sources: 2 BMS CSR, 106 abstracts, 1 STA submission ACR50: 4.50 (2.23;7.62) stimulation of T cells and is licensed for the treatment of moderate ACR70: 7.17 (2.21;18.88) Certolizumab pegol + MTX to severe active rheumatoid arthritis in adult patients who responded Abstracts Excluded: 1620 ACR20: 2.85 (2.22;3.41) Non-RCT (882) ACR50: 4.79 (2.47;7.91) inadequately to methotrexate (MTX). Other disease (258) ACR70: 8.86 (3.14;23.31) Juvenile arthritis or non-adults (61) Etanercept + MTX Biological therapies have the following major advantages over Intervention or comparison out of scope (219) ACR20: 1.80 (1.06;2.77) Outcome not of interest (161) 1 ACR50: 2.65 (1.24;6.82) conventional Disease Modifying Anti-Rheumatic Drugs (DMARDs) : Potential relevant full text publications: Other (16) ACR70: 3.73 (1.38;18.93) Datastar, Ovid and Cochrane RCT Library: 124 Conferences excluded: (105) their development followed an increased understanding of Golimumab + MTX Other sources: (all) 2 BMS CSR, 106 abstracts, Outcome not of interest or naïve patients (86) ACR20: 2.12 (1.00;3.09) 1 STA submission Publication available (duplicate) (19) pathogenesis of inflammatory arthritis; ACR50: 2.85 (0.71;6.76) ACR70: 4.14 (0.69;16.76) their target is highly specific, with the mode of action easier to Excluded: 57 Infliximab + MTX elucidate than with traditional DMARDs; Study design (15) ACR20: 1.81 (1.03;2.68) Outcomes not of interest (13) ACR50: 2.14 (0.46;5.72) their use in clinical practice has added to the confidence of health- Population (8) ACR70: 3.57 (0.55;13.16) No MTX background, etc. (16) care professionals and patients to be able to satisfactorily control Potential relevant clinical effectiveness documents Other (7) Abatacept + MTX selected: No full paper available (2: 2+0) ACR20: 1.90 (1.24;2.57) disease resistant to conventional therapies, and remission of disease ACR50: 2.62 (1.24;4.95) 63 relevant clinical publications, 2 CSR and 1 STA ACR70: 3.72 (1.50;10.52) is an increasingly realistic aim; and submission Excluded for MTC: 46 1 conference abstract 0.3 0.5 1.0 2.0 4.0 8.0 16.0 32.0 for anti-TNF drugs, and some of the newer biological drugs, Open-label extension (11) Outcome not of interest (15) Favours placebo Favours treatment their action is usually rapid, with good symptom control, and Other cDMARDS (5) Naïve patients (6) significantly greater slowing of radiological progression than Non-relevant biologic (8) conventional DMARDs. Duplicate information (1) The British Society for Rheumatology recommends biological Included for MTC 21 documents: therapies as options for the treatment of adults who have the Abatacept (5 pub, 2 CSR), Adalimumab (2 pub), Certolizumab (3 pub) + (1 STA report), Etanercept (3 pub), Figure 6 – ACR response rates at 6 months all treatments following characteristics 1: Golimumab (1 pub) + (1 abstract) and Infliximab (3 pub) (i) active RA as measured by DAS28>3.2 with at least three or more tender and three or more swollen joints; and (ii) have undergone trials of two conventional DMARDs, including MTX (unless contraindicated). Figure 2 – Network of studies In 2010, abatacept received a license extension for RA patients who inadequately respond to DMARDS including MTX. ATTEST (Schiff 2008, CSR) The effectiveness of abatacept in this patient population has been Abatacept 10 mg/kg Infliximab 3 mg/kg Adalimumab 40 mg every 4 weeks + MTX every 8 weeks + MTX every other week + demonstrated in a series of randomised controlled trials (RCTs): MTX ATTEST, AIM and the Kremer trial 2-7. In the UK NICE recommends the use of adalimumab, etanercept, AIM (Kremer 2006, CSR) ATTEST (Schiff 2008, CSR) Kremer 2005 (Kremer 2003) ATTRACT (Maini 1999, Lipsky 2000) ARMADA (Weinblatt 2003) infliximab and certolizumab pegol as treatment options in patients ATTEST (Schiff 2008, CSR) DE019 (Keystone 2004) who inadequately respond to two DMARDS. In anticipation of its approval Golimumab was also considered as a relevant treatment RAPID I (Keystone 2008) Weinblatt 1999 Certolizumab 200 mg certolizumab submission) TEMPO (Klareskog 2004, Etanercept 25 mg every other week + Placebo + MTX option for this study. RAPID II (Smolen 2009) Van der Heijde 2006) twice weekly + MTX MTX Data demonstrating efficacy of abatacept compared to alternative certolizumab submission) biological agents is lacking, however this can be overcome by means Conclusions GO-FORWARD (Keystone 2009, of an indirect treatment comparison. Genovese 2008 abstract) In order to compare treatment effects, an indirect treatment The results of the indirect treatment comparison showed that comparison adhering to the NICE scope, comparing abatacept abatacept is expected to be more efficacious than placebo, Golimumab 50 mg to adalimumab, etanercept, infliximab, certolizumab pegol and every 4 weeks + MTX and of comparable efficacy relative to the other recommended golimumab was performed 8. biologic DMARDs, in combination with MTX in the UK. Outcome of the indirect treatment comparison was a reduction in All biological agents in combination with MTX are more functional status as measured by the Health Assessment Questionnaire efficacious in terms of HAQ and ACR response rates than (HAQ) score, ACR20, 50 and 70% response rates at 6 months. treatment with MTX alone. The TEMPO18,19 trial included a DMARD-IR population as opposed to Abatacept in combination with MTX is expected to result in a MTX-IR population for the other trials. However, since etanercept a comparable improvement in HAQ score at 6 months as all Objective is only evaluated in two trials (Weinblatt 199917 and TEMPO) and other biological agents Weinblatt 1999 is a relatively old and small study (89 patients At 6 months, all biological agents evaluated are expected To compare the efficacy of abatacept and alternative recommended included), the TEMPO trial was kept in the base case analysis and the to result in comparable proportion of ACR20/50 and 70 biologic DMARDs, via HAQ score and ACR response rates at 6 months, impact of excluding was evaluated in a sensitivity analysis. responders, although certolizumab pegol is expected to have in patients in the UK who have RA and show inadequate response to DE019 Keystone 200413 study included an early escape for non- higher ACR 20 responses. These results should be interpreted methotrexate (MTX-IR). responders. The certolizumab pegol studies specifically withdrew with caution as some differences between the study designs patients who did not show an ACR20 response at weeks 12 and 1414- were observed; in particular the certolizumab pegol studies 16. The GO-FORWARD20,21 study provided rescue therapy for patients withdrew patients that did not show ACR responses at 12 and Method who did not achieve at least 20% improvement in both Tender Joint 14 weeks. Count (TJC) and Swollen Joint Count (SJC) by week 16. Based on its unique mechanism of action, relative efficacy and Systematic review Patient eligibility criteria in the ARMADA12 (adalimumab), Weinblatt et clinical trial safety profile, abatacept is a suitable alternative to A systematic literature search covering the period 1980 to October al 199917 (etanercept), and ATTRACT 11 (infliximab) trials only required currently licensed biologic DMARDs, in particular to infliximab, the 2010 was performed in 2010. The literature review involved searching patients to have a SJC and TJC of ≥6, respectively. These criteria only other biologic delivered by intravenous administration, while in Datastar (1980 – Jan 2010) and Ovid (Jan 2010 – Oct 2010), in are less stringent than those in other trials, and may reflect a less offering another working mechanism. Abatacept in combination which Medline and Embase databases were searched simultaneously. advanced state of RA (for example, in the AIM trial eligible patients with MTX should be available to patients with moderate to severe Additional searches were undertaken using the Cochrane Library, required ≥10 swollen joints and ≥12 tender joints). RA who are refractory to MTX alone. NICE technology appraisals, ACR and EULAR conferences (2008 to 2010). Network meta-analysis results For inclusion, the studies had to meet the following predefined HAQ change from baseline at 6 months. References selection criteria: All treatments were more efficacious versus placebo (Figure 3 & 4) Study design and population: any RCT for the treatment of RA with Abatacept is expected to be as efficacious as all other biologic 1. http://www.rheumatology.org.uk/includes/documents/cm_docs/2010/r/2_ra_guidelines_ an inadequate response or intolerance to previous treatment with on_eligibility_criteria_for_the_first_biological_therapy.pdf DMARDs, with point estimates ranging from -0.11 (vs. infliximab) 2.
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