The primary endpoint (the proportion of patients who achieved a ≥1.2 decrease from baseline in DAS28‑CRP at Week 12) was achieved in 41%, 61%, 54%, 67% and 35% of patients, respectively. At Week 12, 56% of mavrilimumab-treated patients compared with 35% of placebo-treated patients achieved the primary endpoint. All ACR20 categories were reached and all mavrilimumab-treated patients showed a response by Week 2. A dose-dependent decrease in biomarkers was observed at Week 12. Adverse reactions were mild to moderate, with no significant hypersensitivity reactions or infections.
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In the subsequent Phase 2b study (EARTH EXPLORER-1), mavrilimumab achieved its primary endpoint in 326 patients with moderate-to-severe RA with background MTX following 24 weeks of treatment. Patients received mavrilimumab every two weeks at a low (30 mg), medium (100 mg) or high (150 mg) dose.4 The ACR20 response for active-treated groups compared with placebo was 73% and 25% (p<0.001), respectively. The reduction in the mean DAS28 score at Day 85 was -1.9 and -0.68 (p<0.001), respectively. Secondary endpoints of ACR50, ACR70 and DAS28 remission score achieved statistical significance for the high-mavrilimumab dose. Rapid improvements in patient-reported outcomes, including disability, pain and fatigue, were achieved. The most common adverse events were headache, nasopharyngitis, hypertension, bronchitis and RA worsening.
In June, the Food and Drug Administration (FDA) publicly released more than 3 million adverse drug event reports and medication errors in a program called Open FDA.5 The FDA hopes that doing this will lead to new medication applications and research. The data released included reports from 2004–13, which prior to this project were only available through the Freedom of Information Act. The Open FDA Project can be accessed via https://open.fda.gov. More information is available on the FDA’s website.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City, and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Isenberg D, Gordon C, Licu D, et al. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2014 Jun 10. doi: 10.1136/annrheumdis-2013-205067. [Epub ahead of print].
- AstraZeneca announces MedImmune’s mavrilimumab and sifalimumab both met primary endpoints in Phase IIb studies. May 12, 2014. http://www.astrazeneca.com/Media/Press-releases/Article/20140512–astrazeneca-announces-medimmunes-mavrilimumab-sifalimumab-met-primary-endpoints-Phase-IIb-studies.
- Burmester GR, Weinblatt ME, McInnes IB, et al. Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis. Ann Rheum Dis. 2013;72:1445–1452.
- Burmester GR, Takeuchi T, Barbarash O, et al. Presentation #1733: Early and sustained improvement in pain and physical function as measured by visual analog scale and short form-36 physical component summary score in rheumatoid arthritis patients treated with mavrilimumab, an investigational anti-GM-CSFR-alpha monoclonal antibody, in a phase 2a study. ACR/ARHP 2013, San Diego, Oct. 25–30, 2013. https://acr.confex.com/acr/2013/recordingredirect.cgi/id/2398.
- Al-Faruque F. Open FDA project releases millions of reports. The Hill. June 2, 2014. http://thehill.com/policy/healthcare/207922-open-fda