Matching articles for "Crohn's disease"
In Brief: Wezlana — An Ustekinumab Biosimilar Interchangeable with Stelara
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The FDA has approved ustekinumab-auub (Wezlana –
Amgen), an interchangeable biosimilar product similar
to the interleukin-12 and -23 antagonist Stelara, for
treatment of the same indications as Stelara...
The FDA has approved ustekinumab-auub (Wezlana –
Amgen), an interchangeable biosimilar product similar
to the interleukin-12 and -23 antagonist Stelara, for
treatment of the same indications as Stelara (see
Table 1). Wezlana is the first Stelara biosimilar to be
approved in the US.
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
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
Table: Safety of Drugs for IBD in Pregnancy (online only)
The Medical Letter on Drugs and Therapeutics • July 10, 2023; (Issue 1680)
...
View the Table: Safety of Drugs for IBD in Pregnancy
Table: Some Drug Interactions with Drugs for IBD (online only)
The Medical Letter on Drugs and Therapeutics • July 10, 2023; (Issue 1680)
...
View the Table: Some Drug Interactions with Drugs for IBD
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.
In Brief: Extended-Release Budesonide (Ortikos) for Crohn's Disease
The Medical Letter on Drugs and Therapeutics • November 2, 2020; (Issue 1610)
An oral extended-release formulation of the corticosteroid
budesonide (Ortikos – Ferring) is now available
for once-daily treatment of mild to moderate active
Crohn's disease of the ileum and/or ascending...
An oral extended-release formulation of the corticosteroid
budesonide (Ortikos – Ferring) is now available
for once-daily treatment of mild to moderate active
Crohn's disease of the ileum and/or ascending colon in
patients ≥8 years old and for maintenance of remission
for up to 3 months in adults. Ortikos is the second oral
formulation of budesonide to be approved for this
indication; Entocort EC, an ileal-release formulation,
was the first. A third oral formulation of budesonide
(Uceris) is approved for induction of remission in
patients with mild to moderate active ulcerative colitis.
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.
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
Table: Safety of Drugs for IBD in Pregnancy (online only)
The Medical Letter on Drugs and Therapeutics • July 2, 2018; (Issue 1550)
...
View Table: Safety of Drugs for IBD in Pregnancy
Inflectra - An Infliximab Biosimilar
The Medical Letter on Drugs and Therapeutics • January 30, 2017; (Issue 1513)
The FDA has approved infliximab-dyyb (Inflectra –
Pfizer; marketed as Remsima in some countries), as a
biosimilar of the TNF inhibitor infliximab (Remicade).
Infliximab-dyyb was approved in the European...
The FDA has approved infliximab-dyyb (Inflectra –
Pfizer; marketed as Remsima in some countries), as a
biosimilar of the TNF inhibitor infliximab (Remicade).
Infliximab-dyyb was approved in the European Union
(EU) in 2013 and in Canada in 2014. It is the second
biosimilar to be approved by the FDA. Filgastrim-sndz
(Zarxio), a recombinant human granulocyte colony-stimulating
factor, was the first.
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.
In Brief: New Indications for Secukinumab (Cosentyx)
The Medical Letter on Drugs and Therapeutics • June 6, 2016; (Issue 1496)
The FDA has approved the subcutaneous IL-17A antagonist secukinumab (Cosentyx - Novartis), which was first approved in 2015 for treatment of plaque psoriasis, for treatment of psoriatic arthritis and ankylosing...
The FDA has approved the subcutaneous IL-17A antagonist secukinumab (Cosentyx - Novartis), which was first approved in 2015 for treatment of plaque psoriasis, for treatment of psoriatic arthritis and ankylosing spondylitis in adults.1 Secukinumab is one of the most effective drugs available for treatment of plaque psoriasis.2
FDA approval of secukinumab for treatment of psoriatic arthritis was based on two randomized, double-blind trials with a primary endpoint of at least a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 24 weeks. In both trials, ACR20 response rates were significantly higher in patients receiving secukinumab than in those receiving placebo.3,4 Secukinumab was effective in both TNF inhibitor-naive and TNF inhibitor-experienced patients.
Approval of secukinumab for ankylosing spondylitis was based on two double-blind trials in which the primary endpoint was the percentage of patients who achieved at least a 20% improvement in Assessment of Spondyloarthritis International Society response criteria (ASA20) at 16 weeks. In both trials, ASA20 response rates were significantly higher in patients receiving secukinumab than in those receiving placebo.5
The most common adverse effects of secukinumab in clinical trials were nasopharyngitis, diarrhea, and upper respiratory infection. In general, infections occurred at a higher rate in secukinumab-treated patients than in those who received placebo. Patients should be screened for tuberculosis before starting therapy. Exacerbations of Crohn's disease were reported during clinical trials in patients taking secukinumab. Urticaria and anaphylaxis have occurred.
The recommended dosage of secukinumab for patients with psoriatic arthritis (without concomitant moderate to severe plaque psoriasis) or ankylosing spondylitis is 150 mg injected subcutaneously at weeks 0, 1, 2, 3, and 4, then every 4 weeks. The drug can also be given every 4 weeks without the weekly loading doses. The dose can be increased to 300 mg in patients who continue to have active psoriatic arthritis. The cost for one 150 mg/mL single-use pen is $1954.10.6
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FDA approval of secukinumab for treatment of psoriatic arthritis was based on two randomized, double-blind trials with a primary endpoint of at least a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 24 weeks. In both trials, ACR20 response rates were significantly higher in patients receiving secukinumab than in those receiving placebo.3,4 Secukinumab was effective in both TNF inhibitor-naive and TNF inhibitor-experienced patients.
Approval of secukinumab for ankylosing spondylitis was based on two double-blind trials in which the primary endpoint was the percentage of patients who achieved at least a 20% improvement in Assessment of Spondyloarthritis International Society response criteria (ASA20) at 16 weeks. In both trials, ASA20 response rates were significantly higher in patients receiving secukinumab than in those receiving placebo.5
The most common adverse effects of secukinumab in clinical trials were nasopharyngitis, diarrhea, and upper respiratory infection. In general, infections occurred at a higher rate in secukinumab-treated patients than in those who received placebo. Patients should be screened for tuberculosis before starting therapy. Exacerbations of Crohn's disease were reported during clinical trials in patients taking secukinumab. Urticaria and anaphylaxis have occurred.
The recommended dosage of secukinumab for patients with psoriatic arthritis (without concomitant moderate to severe plaque psoriasis) or ankylosing spondylitis is 150 mg injected subcutaneously at weeks 0, 1, 2, 3, and 4, then every 4 weeks. The drug can also be given every 4 weeks without the weekly loading doses. The dose can be increased to 300 mg in patients who continue to have active psoriatic arthritis. The cost for one 150 mg/mL single-use pen is $1954.10.6
- Secukinumab (Cosentyx) for psoriasis. Med Lett Drugs Ther 2015; 57:45.
- Drugs for psoriasis. Med Lett Drugs Ther 2015; 57:81.
- IB McInnes et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386:1137.
- PJ Mease et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015; 373:1329.
- D Baeten et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med 2015; 373:2534.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. May 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.
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Ixekizumab (Taltz) - A Second IL-17A Inhibitor for Psoriasis
The Medical Letter on Drugs and Therapeutics • May 9, 2016; (Issue 1494)
The FDA has approved ixekizumab (Taltz – Lilly), an
injectable humanized interleukin (IL)-17A antagonist,
for treatment of adults with moderate to severe plaque
psoriasis who are candidates for systemic...
The FDA has approved ixekizumab (Taltz – Lilly), an
injectable humanized interleukin (IL)-17A antagonist,
for treatment of adults with moderate to severe plaque
psoriasis who are candidates for systemic therapy
or phototherapy. Ixekizumab is the second IL-17A
antagonist to be approved for this indication in the US;
secukinumab (Cosentyx – Novartis) was the first.
Budesonide Rectal Foam (Uceris) for Ulcerative Colitis
The Medical Letter on Drugs and Therapeutics • November 9, 2015; (Issue 1481)
The FDA has approved a rectal foam formulation of
the corticosteroid budesonide (Uceris - Salix/Valeant)
for induction of remission in patients with active mild
to moderate distal ulcerative colitis (UC)...
The FDA has approved a rectal foam formulation of
the corticosteroid budesonide (Uceris - Salix/Valeant)
for induction of remission in patients with active mild
to moderate distal ulcerative colitis (UC) extending
up to 40 cm from the anal verge. Budesonide is also
available as oral extended-release tablets (also
branded as Uceris) for use in patients with UC and as
oral enteric-coated tablets (Entocort EC, and generics)
for treatment of Crohn's disease.
Vedolizumab (Entyvio) for Inflammatory Bowel Disease
The Medical Letter on Drugs and Therapeutics • September 15, 2014; (Issue 1451)
The FDA has approved vedolizumab (Entyvio - Takeda),
an intravenous integrin receptor antagonist, for treatment
of moderate to severe ulcerative colitis or Crohn's
disease in adults who have not responded...
The FDA has approved vedolizumab (Entyvio - Takeda),
an intravenous integrin receptor antagonist, for treatment
of moderate to severe ulcerative colitis or Crohn's
disease in adults who have not responded to, lost
response to, or cannot tolerate standard treatment.
Natalizumab (Tysabri), another integrin receptor antagonist,
has been available for several years for treatment
of Crohn's disease and multiple sclerosis.
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).
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).
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.
Teduglutide Injection (Gattex) for Short Bowel Syndrome
The Medical Letter on Drugs and Therapeutics • April 15, 2013; (Issue 1414)
The FDA has approved teduglutide (te due’ gloo tide;
Gattex – NPS), a recombinant DNA analog of
glucagon-like peptide-2 (GLP-2), for treatment of short
bowel syndrome (SBS) in adults who are...
The FDA has approved teduglutide (te due’ gloo tide;
Gattex – NPS), a recombinant DNA analog of
glucagon-like peptide-2 (GLP-2), for treatment of short
bowel syndrome (SBS) in adults who are dependent
on parenteral support.
Budesonide (Uceris) for Ulcerative Colitis
The Medical Letter on Drugs and Therapeutics • March 18, 2013; (Issue 1412)
The FDA has approved a new extended-release formulation
of the corticosteroid budesonide (Uceris –
Santarus) for induction of remission in patients with
mild to moderate ulcerative...
The FDA has approved a new extended-release formulation
of the corticosteroid budesonide (Uceris –
Santarus) for induction of remission in patients with
mild to moderate ulcerative colitis.
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.
Drugs for Inflammatory Bowel Disease
The Medical Letter on Drugs and Therapeutics • September 1, 2009; (Issue 85)
Inflammatory bowel disease (IBD) is either Crohn's disease or ulcerative colitis. Drug selection is guided by disease type (Crohn's versus ulcerative colitis), severity and location and whether the goal is...
Inflammatory bowel disease (IBD) is either Crohn's disease or ulcerative colitis. Drug selection is guided by disease type (Crohn's versus ulcerative colitis), severity and location and whether the goal is induction or maintenance of remission. Table 1 on page 66 lists the drugs used to treat IBD with their formulations and cost. Table 2 on page 68 lists the drugs of choice and their doses for different indications. Table 3 on page 71 lists the drugs' adverse effects and recommendations for monitoring. More detailed guidelines are available from the American College of Gastroenterology.
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.
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
Download: U.S. English
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.
Addendum: Probiotics
The Medical Letter on Drugs and Therapeutics • December 3, 2007; (Issue 1275)
(Vol. 49, p. 66, August 13, 2007) A reader has pointed out that Saccharomyces boulardii is not a separate species, but a strain of Saccharomyces cerevisiae. S. cerevisiae (including S. boulardii) has been...
(Vol. 49, p. 66, August 13, 2007) A reader has pointed out that Saccharomyces boulardii is not a separate species, but a strain of Saccharomyces cerevisiae. S. cerevisiae (including S. boulardii) has been reported to cause systemic infection after oral ingestion in both immunocompromised patients and healthy hosts (MJ McCullough et al. J Clin Microbiol 1998; 36:2613).
Probiotics
The Medical Letter on Drugs and Therapeutics • August 13, 2007; (Issue 1267)
Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) that have been used for centuries for their potential health benefits. They are currently marketed for prevention and treatment of...
Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) that have been used for centuries for their potential health benefits. They are currently marketed for prevention and treatment of a variety of disorders, including diarrhea, irritable bowel syndrome and inflammatory bowel disease.