Matching articles for "certolizumab"

Drugs for Plaque Psoriasis

   
The Medical Letter on Drugs and Therapeutics • September 30, 2024;  (Issue 1712)
Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis...
Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis with topical therapy, phototherapy, and systemic drugs have recently been published.
Med Lett Drugs Ther. 2024 Sep 30;66(1712):153-60 | Show Full IntroductionHide Full Introduction

Comparison Table: Some Drugs for Plaque Psoriasis (online only)

   
The Medical Letter on Drugs and Therapeutics • September 30, 2024;  (Issue 1712)
...
View the Comparison Table: Some Drugs for Plaque Psoriasis
Med Lett Drugs Ther. 2024 Sep 30;66(1712):e160-6 | Show Full IntroductionHide Full Introduction

Bimekizumab (Bimzelx) for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • January 22, 2024;  (Issue 1694)
The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for...
The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.
Med Lett Drugs Ther. 2024 Jan 22;66(1694):11-3 | Show Full IntroductionHide Full Introduction

Drugs for Inflammatory Bowel Disease

   
The Medical Letter on Drugs and Therapeutics • July 10, 2023;  (Issue 1680)
Ulcerative colitis (UC) and Crohn's disease (CD), referred to collectively as inflammatory bowel disease (IBD), are chronic immune-mediated inflammatory conditions. Guidelines for treatment of UC and...
Ulcerative colitis (UC) and Crohn's disease (CD), referred to collectively as inflammatory bowel disease (IBD), are chronic immune-mediated inflammatory conditions. Guidelines for treatment of UC and CD have been updated in recent years
Med Lett Drugs Ther. 2023 Jul 10;65(1680):105-12 | Show Full IntroductionHide Full Introduction

Expanded Table: Some Drugs for Inflammatory Bowel Disease (online only)

   
The Medical Letter on Drugs and Therapeutics • July 10, 2023;  (Issue 1680)
...
View the Table: Some Drugs for Inflammatory Bowel Disease
Med Lett Drugs Ther. 2023 Jul 10;65(1680):e115-9 | Show Full IntroductionHide Full Introduction

Risankizumab (Skyrizi) - An IL-23 Antagonist for Crohn's Disease

   
The Medical Letter on Drugs and Therapeutics • December 26, 2022;  (Issue 1666)
The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab...
The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab was approved earlier for treatment of plaque psoriasis and psoriatic arthritis.
Med Lett Drugs Ther. 2022 Dec 26;64(1666):205-7 | Show Full IntroductionHide Full Introduction

Drugs for Rheumatoid Arthritis

   
The Medical Letter on Drugs and Therapeutics • November 15, 2021;  (Issue 1637)
Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were...
Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.
Med Lett Drugs Ther. 2021 Nov 15;63(1637):177-84 | Show Full IntroductionHide Full Introduction

Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis (online only)

   
The Medical Letter on Drugs and Therapeutics • November 15, 2021;  (Issue 1637)
...
View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis
Med Lett Drugs Ther. 2021 Nov 15;63(1637):e187-9 | Show Full IntroductionHide Full Introduction

Flowchart: Rheumatoid Arthritis Treatment (online only)

   
The Medical Letter on Drugs and Therapeutics • November 15, 2021;  (Issue 1637)
...
View the Flowchart: Rheumatoid Arthritis Treatment
Med Lett Drugs Ther. 2021 Nov 15;63(1637):e1 | Show Full IntroductionHide Full Introduction

Drugs for Psoriatic Arthritis

   
The Medical Letter on Drugs and Therapeutics • December 30, 2019;  (Issue 1588)
Psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis. A recent review found that about 20% of patients with psoriasis have psoriatic arthritis. Updated guidelines for...
Psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis. A recent review found that about 20% of patients with psoriasis have psoriatic arthritis. Updated guidelines for treatment of psoriatic arthritis have recently been published.
Med Lett Drugs Ther. 2019 Dec 30;61(1588):203-10 | Show Full IntroductionHide Full Introduction

Drugs for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • June 17, 2019;  (Issue 1574)
Mild to moderate psoriasis can be treated with topical drugs or with phototherapy. Patients with moderate to severe disease generally require systemic...
Mild to moderate psoriasis can be treated with topical drugs or with phototherapy. Patients with moderate to severe disease generally require systemic therapy.
Med Lett Drugs Ther. 2019 Jun 17;61(1574):89-96 | Show Full IntroductionHide Full Introduction

Expanded Table: Some Drugs for Psoriasis (online only)

   
The Medical Letter on Drugs and Therapeutics • June 17, 2019;  (Issue 1574)
...
View the Expanded Table: Some Drugs for Psoriasis
Med Lett Drugs Ther. 2019 Jun 17;61(1574):e96-103 | Show Full IntroductionHide Full Introduction

Risankizumab (Skyrizi) for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • June 3, 2019;  (Issue 1573)
The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist...
The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) and tildrakizumab (Ilumya) were approved earlier.
Med Lett Drugs Ther. 2019 Jun 3;61(1573):81-3 | Show Full IntroductionHide Full Introduction

Tildrakizumab (Ilumya) - Another IL-23 Antagonist for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • January 14, 2019;  (Issue 1563)
Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy...
Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is the second selective IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) was the first.
Med Lett Drugs Ther. 2019 Jan 14;61(1563):4-6 | Show Full IntroductionHide Full Introduction

Drugs for Rheumatoid Arthritis

   
The Medical Letter on Drugs and Therapeutics • July 30, 2018;  (Issue 1552)
Disease-modifying antirheumatic drugs (DMARDs) are used for initial treatment of rheumatoid arthritis (RA) to achieve clinical remission and prevent irreversible joint damage (see Table 1). DMARDs generally...
Disease-modifying antirheumatic drugs (DMARDs) are used for initial treatment of rheumatoid arthritis (RA) to achieve clinical remission and prevent irreversible joint damage (see Table 1). DMARDs generally do not have an immediate analgesic effect, but over time they can control symptoms and have been shown to delay and possibly stop progression of the disease. Methotrexate (Trexall, and others) is generally the drug of choice; it can be used for patients with low, moderate, or high disease activity. For mild disease, some clinicians prefer to start with hydroxychloroquine (Plaquenil, and generics) and/or sulfasalazine (Azulfidine, and others).
Med Lett Drugs Ther. 2018 Jul 30;60(1552):123-8 | Show Full IntroductionHide Full Introduction

Drugs for Inflammatory Bowel Disease

   
The Medical Letter on Drugs and Therapeutics • July 2, 2018;  (Issue 1550)
Management of both ulcerative colitis (UC) and Crohn's disease (CD) is based on disease severity. Disease location (proctitis, left-sided colitis, or extensive colitis) also plays a role in drug selection....
Management of both ulcerative colitis (UC) and Crohn's disease (CD) is based on disease severity. Disease location (proctitis, left-sided colitis, or extensive colitis) also plays a role in drug selection. Some drugs for induction and maintenance of remission of inflammatory bowel disease (IBD) are listed in Table 1.
Med Lett Drugs Ther. 2018 Jul 2;60(1550):107-14 | Show Full IntroductionHide Full Introduction

Table: Drugs for Crohn's Disease (online only)

   
The Medical Letter on Drugs and Therapeutics • July 2, 2018;  (Issue 1550)
...
View Table: Drugs for Crohn's Disease
Med Lett Drugs Ther. 2018 Jul 2;60(1550):e115 | Show Full IntroductionHide Full Introduction

Expanded Table: Some Drugs for Inflammatory Bowel Disease (online only)

   
The Medical Letter on Drugs and Therapeutics • July 2, 2018;  (Issue 1550)
...
View Expanded Table: Some Drugs for Inflammatory Bowel Disease
Med Lett Drugs Ther. 2018 Jul 2;60(1550):e117-22 | Show Full IntroductionHide Full Introduction

Sarilumab (Kevzara) for Rheumatoid Arthritis

   
The Medical Letter on Drugs and Therapeutics • August 14, 2017;  (Issue 1527)
The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi) for second-line treatment of adults with moderately to severely active rheumatoid arthritis (RA). It is the second...
The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi) for second-line treatment of adults with moderately to severely active rheumatoid arthritis (RA). It is the second IL-6 inhibitor to be approved for this indication; tocilizumab (Actemra) was approved earlier.
Med Lett Drugs Ther. 2017 Aug 14;59(1527):134-6 | Show Full IntroductionHide Full Introduction

Ustekinumab (Stelara) for Crohn's Disease

   
The Medical Letter on Drugs and Therapeutics • January 2, 2017;  (Issue 1511)
The FDA has approved the human interleukin (IL)-12 and -23 antagonist ustekinumab (Stelara – Janssen Biotech) for treatment of moderately to severely active Crohn's disease in adults who were intolerant of...
The FDA has approved the human interleukin (IL)-12 and -23 antagonist ustekinumab (Stelara – Janssen Biotech) for treatment of moderately to severely active Crohn's disease in adults who were intolerant of or whose disease was unresponsive to treatment with immunomodulators or corticosteroids, or a tumor necrosis factor (TNF) inhibitor. Ustekinumab was approved earlier for treatment of psoriasis and psoriatic arthritis.
Med Lett Drugs Ther. 2017 Jan 2;59(1511):5-6 | Show Full IntroductionHide Full Introduction

Drugs for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • June 8, 2015;  (Issue 1470)
Mild to moderate psoriasis is generally treated with topical corticosteroids. Vitamin D analogs and tazarotene are topical alternatives that can be used in combination with topical corticosteroids....
Mild to moderate psoriasis is generally treated with topical corticosteroids. Vitamin D analogs and tazarotene are topical alternatives that can be used in combination with topical corticosteroids. Phototherapy and systemic therapy, including biologic agents, are recommended for patients with moderate to severe disease.
Med Lett Drugs Ther. 2015 Jun 8;57(1470):81-4 | Show Full IntroductionHide Full Introduction

Drugs for Psoriatic Arthritis (online only)

   
The Medical Letter on Drugs and Therapeutics • June 8, 2015;  (Issue 1470)
Psoriatic arthritis is a chronic inflammatory arthropathy that develops in up to 40% of patients with psoriasis. Several guidelines for treatment of psoriatic arthritis have been...
Psoriatic arthritis is a chronic inflammatory arthropathy that develops in up to 40% of patients with psoriasis. Several guidelines for treatment of psoriatic arthritis have been published.
Med Lett Drugs Ther. 2015 Jun 8;57(1470):e88-92 | Show Full IntroductionHide Full Introduction

Drugs for Rheumatoid Arthritis

   
The Medical Letter on Drugs and Therapeutics • December 22, 2014;  (Issue 1458)
For initial treatment of rheumatoid arthritis, most expert clinicians prescribe a disease-modifying antirheumatic drug (DMARD) and add a nonsteroidal anti-inflammatory drug (NSAID) or a corticosteroid to...
For initial treatment of rheumatoid arthritis, most expert clinicians prescribe a disease-modifying antirheumatic drug (DMARD) and add a nonsteroidal anti-inflammatory drug (NSAID) or a corticosteroid to control symptoms. Methotrexate is generally the DMARD of choice...

DMARDs
Disease-modifying antirheumatic drugs (DMARDs) are used early in the treatment of rheumatoid arthritis (RA) to achieve clinical remission, prevent irreversible damage to joints, and minimize toxicity associated with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids. DMARDs generally do not have an immediate analgesic effect, but over time can control symptoms and have been shown to delay and possibly stop progression of the disease. Methotrexate (Rheumatrex, and others) is generally the first DMARD prescribed; it can be used to treat mild, moderate, or severe RA. For mild disease, some clinicians prefer to start with hydroxychloroquine (Plaquenil, and generics) and/or sulfasalazine (Azulfidine, and others).
Med Lett Drugs Ther. 2014 Dec 22;56(1458):127-32 | Show Full IntroductionHide Full Introduction

Drugs for Inflammatory Bowel Disease

   
The Medical Letter on Drugs and Therapeutics • August 4, 2014;  (Issue 1448)
Aminosalicylates are effective for induction and maintenance of remission in mild to moderate ulcerative colitis. They are not recommended for treatment of Crohn's disease. FORMULATIONS — Oral mesalamine...
Aminosalicylates are effective for induction and maintenance of remission in mild to moderate ulcerative colitis. They are not recommended for treatment of Crohn's disease.

FORMULATIONS — Oral mesalamine is rapidly absorbed in the small intestine and most of the drug does not reach the colon. Pentasa releases mesalamine gradually throughout the gastrointestinal tract. Delzicol, Asacol HD, Lialda, and Apriso delay the release of the drug until it reaches the distal ileum and colon. Sulfasalazine (Azulfidine, and generics), balsalazide (Colazal, and others), and olsalazine (Dipentum) are prodrugs; mesalamine is azo-bonded to a second moiety and released in the colon following bacterial cleavage of the bond. Mesalamine is also available as an enema (Rowasa, and generics) and as a rectal suppository (Canasa).
Med Lett Drugs Ther. 2014 Aug 4;56(1448):65-72 | Show Full IntroductionHide Full Introduction

Certolizumab Pegol (Cimzia) and Ustekinumab (Stelara) for Psoriatic Arthritis

   
The Medical Letter on Drugs and Therapeutics • February 3, 2014;  (Issue 1435)
Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human...
Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human interleukin-12 and -23 antagonist previously approved for treatment of moderate-to-severe plaque psoriasis, have now been approved by the FDA for treatment of active psoriatic arthritis.
Med Lett Drugs Ther. 2014 Feb 3;56(1435):10-2 | Show Full IntroductionHide Full Introduction

TNF Inhibitors for Crohn's Disease: When, Which, and for How Long

   
The Medical Letter on Drugs and Therapeutics • December 23, 2013;  (Issue 1432)
Three tumor necrosis factor (TNF) inhibitors – infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia) – are approved by the FDA for treatment of moderately to severely active...
Three tumor necrosis factor (TNF) inhibitors – infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia) – are approved by the FDA for treatment of moderately to severely active Crohn’s disease in adults who have had an inadequate response to conventional therapy. Infliximab is also FDA-approved for the same indication in children ≥6 years old and for treatment of fistulas in adults. All 3 TNF inhibitors have been shown to reduce the signs and symptoms of Crohn's disease in clinical trials. They have been associated with adverse effects such as tuberculosis, other serious infections, and lymphoma, and they are expensive.
Med Lett Drugs Ther. 2013 Dec 23;55(1432):102-3 | Show Full IntroductionHide Full Introduction

Tofacitinib (Xeljanz) for Rheumatoid Arthritis

   
The Medical Letter on Drugs and Therapeutics • January 7, 2013;  (Issue 1407)
The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who...
The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of methotrexate. Ruxolitinib (Jakafi) is the only other JAK inhibitor available in the US; it is FDA-approved for treatment of myelofibrosis.
Med Lett Drugs Ther. 2013 Jan 7;55(1407):1-3 | Show Full IntroductionHide Full Introduction

Drugs for Rheumatoid Arthritis

   
The Medical Letter on Drugs and Therapeutics • May 1, 2012;  (Issue 117)
Disease-modifying anti-rheumatic drugs (DMARDs) are now used early in the treatment of rheumatoid arthritis (RA) to achieve clinical remission, prevent irreversible damage to joints, and minimize...
Disease-modifying anti-rheumatic drugs (DMARDs) are now used early in the treatment of rheumatoid arthritis (RA) to achieve clinical remission, prevent irreversible damage to joints, and minimize toxicity associated with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids. DMARDs (Table 1) generally do not have an immediate analgesic effect, but over time can control symptoms and have been shown to delay and possibly stop progression of the disease. NSAIDs have immediate analgesic and antiinflammatory effects, but may not affect the disease process. Oral corticosteroids can relieve joint symptoms and control systemic manifestations, but their chronic use can cause many complications. Judicious use of intra-articular corticosteroids can rapidly decrease inflammation in acute joints with few, if any, adverse effects.
Treat Guidel Med Lett. 2012 May;10(117):37-44 | Show Full IntroductionHide Full Introduction

Drugs for Tuberculosis

   
The Medical Letter on Drugs and Therapeutics • April 1, 2012;  (Issue 116)
Tuberculosis (TB) is still a common cause of death worldwide, and the prevalence of drug-resistant TB poses challenges to its treatment and control. Guidelines with detailed management recommendations are...
Tuberculosis (TB) is still a common cause of death worldwide, and the prevalence of drug-resistant TB poses challenges to its treatment and control. Guidelines with detailed management recommendations are available from the American Thoracic Society, Centers for Disease Control and Prevention (CDC) and Infectious Diseases Society of America (IDSA).
Treat Guidel Med Lett. 2012 Apr;10(116):29-36 | Show Full IntroductionHide Full Introduction

Drugs for Inflammatory Bowel Disease

   
The Medical Letter on Drugs and Therapeutics • March 1, 2012;  (Issue 115)
Inflammatory bowel disease (IBD) is generally classified as either Crohn’s disease (CD) or ulcerative colitis (UC). More detailed guidelines on their treatment are available from the American College...
Inflammatory bowel disease (IBD) is generally classified as either Crohn’s disease (CD) or ulcerative colitis (UC). More detailed guidelines on their treatment are available from the American College of Gastroenterology.
Treat Guidel Med Lett. 2012 Mar;10(115):19-28 | Show Full IntroductionHide Full Introduction

Which TNF Inhibitor for Rheumatoid Arthritis?

   
The Medical Letter on Drugs and Therapeutics • May 17, 2010;  (Issue 1338)
The FDA has approved five tumor necrosis factor (TNF) inhibitors for treatment of moderately to severely active rheumatoid arthritis (RA). TNF-α is a pro-inflammatory cytokine involved in the...
The FDA has approved five tumor necrosis factor (TNF) inhibitors for treatment of moderately to severely active rheumatoid arthritis (RA). TNF-α is a pro-inflammatory cytokine involved in the pathogenesis of many systemic inflammatory disorders.
Med Lett Drugs Ther. 2010 May 17;52(1338):38-9 | Show Full IntroductionHide Full Introduction

Drugs for Tuberculosis

   
The Medical Letter on Drugs and Therapeutics • October 1, 2009;  (Issue 86)
Even though the incidence continues to decline in the United States, tuberculosis (TB) is still a common cause of death worldwide, and the prevalence of drug-resistant TB poses severe challenges to its...
Even though the incidence continues to decline in the United States, tuberculosis (TB) is still a common cause of death worldwide, and the prevalence of drug-resistant TB poses severe challenges to its treatment and control. Guidelines with detailed management recommendations are available from the Centers for Disease Control and Prevention (CDC), American Thoracic Society and Infectious Diseases Society of America (IDSA).
Treat Guidel Med Lett. 2009 Oct;7(86):75-82 | Show Full IntroductionHide Full Introduction

Golimumab (Simponi) for Inflammatory Arthritis

   
The Medical Letter on Drugs and Therapeutics • July 13, 2009;  (Issue 1316)
Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in...
Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate; (2) active psoriatic arthritis (PsA) alone or in combination with methotrexate; and (3) active ankylosing spondylitis (AS).
Med Lett Drugs Ther. 2009 Jul 13;51(1316):55-6 | Show Full IntroductionHide Full Introduction

Certolizumab (Cimzia) for Crohn's Disease

   
The Medical Letter on Drugs and Therapeutics • October 20, 2008;  (Issue 1297)
The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is...
The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is the third TNF blocker approved for this indication.
Med Lett Drugs Ther. 2008 Oct 20;50(1297):81-2 | Show Full IntroductionHide Full Introduction

Correction: Natalizumab (Tysabri) for Crohn's Disease

   
The Medical Letter on Drugs and Therapeutics • June 2, 2008;  (Issue 1287)
The May 5, 2008 article (Med Lett Drugs Ther 2008; 50:34) on the approval of natalizumab (Tysabri) for treatment of Crohn's disease in the "Adverse Effects" section on page 35 included the statement:...
The May 5, 2008 article (Med Lett Drugs Ther 2008; 50:34) on the approval of natalizumab (Tysabri) for treatment of Crohn's disease in the "Adverse Effects" section on page 35 included the statement: "post-marketing hepatotoxicity, sometimes fatal or requiring liver transplantation, has occurred." Actually, no fatal hepatotoxicity or liver transplantation has been reported to date. The FDA warning about post-marketing hepatotoxicity with Tysabri that was the basis for our statement said: "The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to [emphasis added] death or the need for a liver transplant in some patients." Also, in the last sentence of the Conclusion, we should have said: "Because of the risk of serious hepatic toxicity and the rare but even more serious risk of developing progressive multifocal leukoencephalopathy, it should be used only in patients who have not responded to other drugs, including a TNF inhibitor." The italicized words should be substituted for "it is FDA-approved for use."

Download: U.S. English
Med Lett Drugs Ther. 2008 Jun 2;50(1287):44 | Show Full IntroductionHide Full Introduction

Natalizumab (Tysabri) for Crohn's Disease

   
The Medical Letter on Drugs and Therapeutics • May 5, 2008;  (Issue 1285)
Natalizumab (Tysabri - Elan and Biogen) is a monoclonal antibody approved for induction and maintenance treatment of moderate to severe Crohn's disease (CD) refractory to conventional therapies and inhibitors...
Natalizumab (Tysabri - Elan and Biogen) is a monoclonal antibody approved for induction and maintenance treatment of moderate to severe Crohn's disease (CD) refractory to conventional therapies and inhibitors of tumor necrosis factor (TNF). Initially approved in 2004 for the treatment of multiple sclerosis (MS), natalizumab was temporarily withdrawn from the market after 3 patients developed progressive multifocal leukoencephalopathy (PML). It is now available for treatment of both MS and CD through a restricted distribution program.
Med Lett Drugs Ther. 2008 May 5;50(1285):34-6 | Show Full IntroductionHide Full Introduction