Mavrilimumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | GMCSF receptor &alpha-chain |
| Identifiers | |
| CAS Number |
1085337-57-0  |
| ATC code | None |
| IUPHAR/BPS | 7785 |
| ChemSpider | none |
| UNII |
1158JD1P9A  |
| Chemical data | |
| Formula | C6706H10438N1762O2104S54 |
| Molar mass | 143.2 kg/mol |
| (what is this?) (verify) | |
Mavrilimumab is a human monoclonal antibody designed for the treatment of rheumatoid arthritis.[1] It is an inhibitor of human granulocyte macrophage colony-stimulating factor receptor (GM-CSF-R).[2]
Mavrilimumab was discovered as CAM-3001 by Cambridge Antibody Technology and is being developed by MedImmune, Inc.[3]
It has so far shown positive results in phase 1[2] and phase 2a clinical trials.[4] A phase 2a trial which studied mavrilimumab doses of up to 100 mg, reported that 55.7% of subjects met the primary endpoint of "a ≥1.2 decrease from baseline in Disease Activity Score (DAS28-CRP) at week 12" (vs. only 34.7% of placebo subjects).[4] Two further clinical studies are reported to be underway in rheumatoid arthritis patients to investigate these effects further.[5]
Preliminary results, from a phase IIb study investigating doses of 30, 100 and 150 mg mavrilimumab over 24 weeks, were presented at a rheumatology conference in Rome, in August 2015. At week 24, 40.15% of patients in the top dose group achieved an ACR50 response compared to 3.7% in the placebo group. Rates of remission and low disease activity were reported to be significantly higher in the 150-mg group. [6] Patients who completed this and a second US clinical study were enrolled into an open-label extension study to evaluate the longer term efficacy and safety of mavrilumumab for up to 74 weeks of treatment, presented at a rheumatology conference in San Francisco in November 2015. The authors concluded that 150 mg mavrilimumab was optimal for patients who had prior inadequate response to non-biological DMARDs compared to a dose of 100 mg every other week which had produced positive results in patients still receiving methotrexate.[7]
References
- ↑ "Statement On A Nonproprietary Name Adopted By The USAN Council: Mavrilimumab" (PDF). American Medical Association.
- 1 2 Gerd R Burmester, Eugen Feist, Matthew A Sleeman, Bing Wang, Barbara White and Fabio Magrini (1 September 2011). "Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-α, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study". Ann. Rheum. Dis. 70 (9): 1542–1549. doi:10.1136/ard.2010.146225. PMC 3147227. Retrieved 24 February 2016.
- ↑ http://www.ama-assn.org/resources/doc/usan/mavrilimumab.pdf
- 1 2 Gerd R Burmester, Michael E Weinblatt, Iain B McInnes, Duncan Porter, Olga Barbarash, Mykola Vatutin, Istvan Szombati, Ehsanollah Esfandiari, Matthew A Sleeman, Christopher D Kane, Guy Cavet, Bing Wang, Alex Godwood, Fabio Magrini, and the EARTH Study Group. "Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis". Ann Rheum Dis. 72 (9): 1445–1452. doi:10.1136/annrheumdis-2012-202450. PMC 3756523. Retrieved 24 February 2016.
- ↑ Manuela Di Franco, Maria Chiara Gerardi, Bruno Lucchino, and Fabrizio Conti (12 March 2014). "Mavrilimumab: an evidence based review of its potential in the treatment of rheumatoid arthritis". Core Evidence 9: 41–48. doi:10.2147/CE.S39770. PMC 3958547. Retrieved 24 February 2016.
- ↑ Nancy Walsh (15 June 2015). "Targeting GM-CSF Succeeds in RA - Primary endpoints met in phase IIb study of mavrilimumab". MedPageToday. Retrieved 24 February 2016.
- ↑ G Burmester, IB McInnes, JM Kremer, P Miranda, J Vencovský, A Godwood, M Albulescu, D Close and Michael Weinblatt (29 September 2015). "Abstract Number 3111: Long-term Safety and Efficacy of Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor-α (GM–CSFR-α) Monoclonal Antibody, in Patients with Rheumatoid Arthritis (RA) [abstract]". Arthritis Rheumatol. (American College of Rheumatology) 67 (suppl 10).