Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late Phase 3 trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent to you in print and CD ROM forms and are available online. Monographs can be customized to meet the needs of your facility. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X.
Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The April 2005 omega-3-acid ethyl esters capsules, iloprost inhalation solution, clofarabine, pegaptanib, and meningococcal conjugate vaccine. The DUE is on omega-3-acid ethyl esters capsules.
Biogen Idec and Elan submit Biologics License Application to the FDA for approval of Antegren for multiple sclerosis based on one-year data [press release].San Diego, CA: Elan Corporation and Biogen Idec; May 25, 2004. Available at: http://www.elan.com/News/full.asp?ID=575243. Accessed on May 25, 2004.
3.
MillerD.H., KhanO.A., SheremataW.A.A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med.2003; 348: 15–23.
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GhoshS., GoldinE., GordonF.H.Natalizumab for active Crohn's disease. N Engl J Med.2003; 348: 24–32.
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SandbornW.J., YednockT.A.Novel approaches to treating inflammatory bowel disease: targeting alpha-4 integrin. Am J Gastroenterol.2003; 98: 2372–2382.
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von AndrianU.H., EngelhardtB.Alpha4 integrins as therapeutic targets in autoimmune disease. N Engl J Med.2003; 348: 68–72.
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GhoshS.Alpha4 integrin blockade in inflammatory bowel disease. Ann Rheum Dis.2003; 62(suppl 1): ii70–ii72.
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CarterJ.L., AgiusM., MassM.A placebo-controlled, pharmacodynamic, pharmacokinetic, tolerability and safety study of three doses of intravenous natalizumab in multiple sclerosis [abstract]. Neurology.2000; 54(suppl 1): A259.
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PanaccioneR., ColombelJ.F., EnnsR.A.Comparability of natalizumab pharmacokinetics (PK), α4-integrin receptor saturation and clinical response in patients with Crohn's disease (CD) treated once monthly IV with either a fixed dose of 300 mg (ENACT-1) or doses of 3 or 6 mg/kg [abstract]. Gastroenterology.2004; 126(suppl 1): A-76. Abstract 584.
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GordonF.H., HamiltonM.I., DonoghueS.A pilot study of treatment of active ulcerative colitis with natalizumab, a humanized monoclonal antibody to alpha-4 integrin. Aliment Pharmacol Ther.2002; 16: 699–705.
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SheremataW.A., VollmerT.L., StoneL.A., Willmer-HulmeA.J., KollerM.A safety and pharmacokinetic study of intravenous natalizumab in patients with MS. Neurology.1999; 52: 1072–1074.
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O'ConnorP.W., GoodmanA., Willmer-HulmeA.J.Randomized multicenter trial of natalizumab in acute MS relapses: clinical and MRI effects. Neurology.2004; 62: 2038–2043.
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GordonF.H., LaiC.W.Y., HamiltonM.I.A randomized placebo-controlled trial of a humanized monoclonal antibody to α4 integrin in active Crohn's disease. Gastroenterology.2001; 121: 268–274.
14.
DaltonC.M., MiszkielK.A., BarkerG.J.Effect of natalizumab on conversion of gadolinium enhancing lesions to T1 hypointense lesions in relapsing multiple sclerosis. J Neurol.2004; 251: 407–413.
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TubridyN., BehanP.O., CapildeoR.The effect of anti-alpha4 integrin antibody on brain lesion activity in MS. Neurology.1999; 53: 466–472.
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SheremataW.A., MinagarA., HumeA., KollerM., VollmerT.Reduction of relapses in multiple sclerosis after natalizumab (Antegren) treatment [abstract]. Ann Neurol.1998; 44: 507.
17.
RutgeertsP., AllisonM.C., CortotA.Effects of natalizumab on gut healing in a phase 3 study of active Crohn's disease therapy (ENACT-1) [abstract]. Gastroenterology.2004; 126(4, suppl 2): A208.
18.
LawranceI.C., ColombelJ-F, EnnsR.A.Pharmacodynamic results from a phase 3 study evaluating natalizumab therapy of active Crohn's disease (ENACT-1) [abstract]. Gastroenterology.2004; 126(4, suppl 2): A211.
19.
EnnsR.A., ColumbelJ.F., FeaganB.G.Safety, tolerability and immunogenicity of natalizumab in a phase III study of active Crohn's disease therapy (ENACT-1) [abstract]. Gastroenterology.2004; 126(4, suppl 2): A462.
20.
SandbornW.J., ColombelJ.F., EnnsR.A.Efficacy of assessment of natalizumab in patients with Crohn's disease and prior history of anti-TNF therapy: results from ENACT-1 [abstract]. Gastroenterology.2004; 126(4, suppl 2):A276.
21.
GeboesK., AllisonM.C., CortotA.Natalizumab decreases inflammatory cells within the colonic lamina propria of patients with active Crohn's disease: results from ENACT-1 [abstract]. Gastroenterology.2004; 126(4, suppl 2):A213.
22.
SandbornW.J., ColombelJ.F., EnnsR.A phase III, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of Antegren (natalizumab) in maintaining clinical response and remission in Crohn's disease (ENACT-2) [abstract]. Gastroenterology.2004; 127(1): 332.
23.
SandbornW.J., ColombelJ.F., EnnsR.Efficacy assessment of natalizumab in patients with Crohn's disease and prior history of infliximab therapy: results from ENACT-2 [abstract]. Gut.2004; 53(suppl 1): A229.
24.
LewD.A., StoffelE.M.Natalizumab for active Crohn's disease. N Engl J Med.2003; 348: 1599.
25.
SandsB.E., KozarekR.A., SpainhourJ.Safety and tolerability of natalizumab in patients concurrently receiving infliximab in a phase 2 study of active Crohn's disease [abstract]. Gastroenterology.2004; 126(4, suppl 2):A463.
26.
Elan and Biogen Idec announce initiation of Antegren rheumatoid arthritis trial; phase II study to begin first half of 2004 [press release].San Diego, CA: Elan Corporation, plc and Biogen ldec; February 3, 2004. Available at: http://www.elan.com/news/full.asp?ID=490922. Accessed on December 1, 2004.
27.
van DeventerS.J., EnnsR., ColombelJ.F.6-month safety, tolerability and immunogenicity results of natalizumab in patients with Crohn's disease [abstract]. Gut.2004; 53(suppl 1): A229.
28.
VollmerT.L., PhillipsJ.T., GoodmanA.D.An open-label safety and drug interaction study of natalizumab (Antegren) in combination with interferonbeta (Avonex) in patients with multiple sclerosis. Mult Scler.2004; 10: 511–520.
29.
GoodmanA., Bar-OrA., MillerA.GLANCE: a double-blind, randomised, placebo-controlled, parallel-group safety study of natalizumab (Antegren) in combination with glatiramer acetate (Copaxone) in subjects with relapsing-remitting multiple sclerosis [abstract]. J Neurol.2004; 251(suppl 1): III/176–177.
30.
SandsB.E., KozarekR.A., SpainhourJ.Efficacy of natalizumab in patients concurrently receiving infliximab in a phase 2 study of active Crohn's disease [abstract]. Gut.2004; 53(suppl 1): A229.
