Matching articles for "Olumiant"
Ritlecitinib (Litfulo) for Severe Alopecia Areata
The Medical Letter on Drugs and Therapeutics • November 27, 2023; (Issue 1690)
The FDA has approved ritlecitinib (Litfulo – Pfizer), an
oral JAK and TEC kinase family inhibitor, for treatment
of severe alopecia areata in patients ≥12 years old.
Ritlecitinib is the second oral drug...
The FDA has approved ritlecitinib (Litfulo – Pfizer), an
oral JAK and TEC kinase family inhibitor, for treatment
of severe alopecia areata in patients ≥12 years old.
Ritlecitinib is the second oral drug to be approved
in the US for treatment of severe alopecia areata;
baricitinib (Olumiant), a JAK inhibitor, is approved
only for use in adults.
COVID-19 Update: An EUA for Vilobelimab (Gohibic) for COVID-19
The Medical Letter on Drugs and Therapeutics • May 29, 2023; (Issue 1677)
The investigational anti-complement component 5a
(C5a) antibody vilobelimab (Gohibic – InflaRx) has
been granted an FDA Emergency Use Authorization
(EUA) for IV treatment of hospitalized adults
with...
The investigational anti-complement component 5a
(C5a) antibody vilobelimab (Gohibic – InflaRx) has
been granted an FDA Emergency Use Authorization
(EUA) for IV treatment of hospitalized adults
with COVID-19 beginning within 48 hours after
invasive mechanical ventilation (IMV) or extracorporeal
membrane oxygenation (ECMO) is started.
Vilobelimab is the first anti-C5a antibody to become
available in the US.
COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • January 9, 2023; (Issue 1667)
The interleukin-6 (IL-6) receptor antagonist
tocilizumab (Actemra – Genentech) has been
approved by the FDA for IV treatment of COVID-19
in hospitalized adults who are receiving a systemic
corticosteroid...
The interleukin-6 (IL-6) receptor antagonist
tocilizumab (Actemra – Genentech) has been
approved by the FDA for IV treatment of COVID-19
in hospitalized adults who are receiving a systemic
corticosteroid and require supplemental oxygen,
mechanical ventilation, or extracorporeal membrane
oxygenation (ECMO). Tocilizumab was previously
available for this indication under an Emergency
Use Authorization (EUA); it remains available under
an EUA for treatment of children 2-17 years old
who are hospitalized with COVID-19 and require
oxygen support.
An EUA for Anakinra (Kineret) for COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • December 12, 2022; (Issue 1665)
The recombinant interleukin-1 (IL-1) receptor
antagonist anakinra (Kineret – Sobi) has been
granted an FDA Emergency Use Authorization
(EUA) for treatment of hospitalized adults with
confirmed COVID-19...
The recombinant interleukin-1 (IL-1) receptor
antagonist anakinra (Kineret – Sobi) has been
granted an FDA Emergency Use Authorization
(EUA) for treatment of hospitalized adults with
confirmed COVID-19 pneumonia who require low- or
high-flow supplemental oxygen, are at risk of
progressing to severe respiratory failure, and are
likely to have elevated plasma levels of soluble
urokinase plasminogen activator receptor (suPAR).
Anakinra has been available in the US for years; it
is FDA-approved for multiple indications, including
rheumatoid arthritis. Assays for suPAR are not
commercially available in the US.
Baricitinib (Olumiant) for Severe Alopecia Areata
The Medical Letter on Drugs and Therapeutics • September 5, 2022; (Issue 1658)
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant – Lilly), which was previously approved by
the FDA for treatment of moderately to severely active
rheumatoid arthritis and treatment of COVID-19...
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant – Lilly), which was previously approved by
the FDA for treatment of moderately to severely active
rheumatoid arthritis and treatment of COVID-19 in
certain hospitalized adults, has now been approved
for treatment of severe alopecia areata in adults.
Baricitinib is the first systemic treatment to be
approved in the US for this indication.
COVID-19 Update: Baricitinib (Olumiant) FDA-Approved for Treatment of COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
The FDA has approved the oral Janus kinase (JAK) inhibitor baricitinib (Olumiant) for treatment of COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal...
The FDA has approved the oral Janus kinase (JAK) inhibitor baricitinib (Olumiant) for treatment of COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for use in children 2-17 years old hospitalized with COVID-19 who require oxygen support.
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.
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
Flowchart: Rheumatoid Arthritis Treatment (online only)
The Medical Letter on Drugs and Therapeutics • November 15, 2021; (Issue 1637)
...
View the Flowchart: Rheumatoid Arthritis Treatment
In Brief: New Warnings for Janus Kinase Inhibitors
The Medical Letter on Drugs and Therapeutics • October 4, 2021; (Issue 1634)
The FDA has required updates to the boxed warnings
in the labeling of the Janus kinase (JAK) inhibitors
tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant),
and upadacitinib (Rinvoq) describing...
The FDA has required updates to the boxed warnings
in the labeling of the Janus kinase (JAK) inhibitors
tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant),
and upadacitinib (Rinvoq) describing increased risks
of major adverse cardiovascular events, malignancy,
thrombosis, and death with their use. The new warnings
were prompted by the results of a postmarketing safety
trial with tofacitinib and were added to the labels of
baricitinib and upadacitinib based on the presumption
of a class effect. The tofacitinib package insert had
contained a boxed warning about an increased risk
of thrombosis and mortality with a dosage of 10 mg
twice daily since 2019, but the new warnings are not
limited by dose.
An EUA for Tocilizumab (Actemra) for COVID-19
The Medical Letter on Drugs and Therapeutics • July 26, 2021; (Issue 1629)
The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an
Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2
years...
The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an
Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2
years old who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical
ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab has been approved by the FDA
for various indications, including rheumatoid arthritis and juvenile idiopathic arthritis.
Drugs for Atopic Dermatitis
The Medical Letter on Drugs and Therapeutics • June 15, 2020; (Issue 1600)
Atopic dermatitis (AD; also known as eczema) is
frequently associated with other atopic disorders
such as allergic rhinitis, asthma, and food allergy. It
commonly presents in infancy and early childhood
and...
Atopic dermatitis (AD; also known as eczema) is
frequently associated with other atopic disorders
such as allergic rhinitis, asthma, and food allergy. It
commonly presents in infancy and early childhood
and has a relapsing course, often improving by
adolescence, but sometimes persisting into (or first
appearing in) adulthood or even old age.
Table: Treatments Considered for COVID-19 (Archived) (online only)
The Medical Letter on Drugs and Therapeutics • April 6, 2020; (Issue 1595)
...
View the Table: Treatments Considered for COVID-19
Upadacitinib (Rinvoq) - A New JAK Inhibitor for Rheumatoid Arthritis
The Medical Letter on Drugs and Therapeutics • November 18, 2019; (Issue 1585)
The FDA has approved upadacitinib (Rinvoq –
Abbvie), an oral Janus kinase (JAK) inhibitor, for
treatment of adults with moderately to severely
active rheumatoid arthritis (RA) who have had
an inadequate...
The FDA has approved upadacitinib (Rinvoq –
Abbvie), 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 cannot tolerate
methotrexate (Trexall, and others). Upadacitinib is
the third JAK inhibitor to be approved in the US for
treatment of RA; tofacitinib (Xeljanz, Xeljanz XR)
and baricitinib (Olumiant) were approved earlier.
In Brief: Risk of Pulmonary Thromboembolism and Death with Tofacitinib (Xeljanz)
The Medical Letter on Drugs and Therapeutics • August 26, 2019; (Issue 1579)
The FDA has required updates to the labeling of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz, Xeljanz XR) based on interim results of a postmarketing safety trial that showed an increased risk of...
The FDA has required updates to the labeling of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz, Xeljanz XR) based on interim results of a postmarketing safety trial that showed an increased risk of pulmonary thromboembolism and death with a dosage of 10 mg twice daily.1 Tofacitinib is approved for treatment of rheumatoid arthritis (RA),2 psoriatic arthritis, and ulcerative colitis.
In the postmarketing trial, RA patients ≥50 years old taking methotrexate who had at least one cardiovascular risk factor were randomized to receive add-on treatment with tofacitinib 5 mg twice daily (the FDA-approved dosage for RA and psoriatic arthritis), tofacitinib 10 mg twice daily (an approved dosage for ulcerative colitis), or a tumor necrosis factor (TNF) inhibitor. At the time of the interim analysis in January 2019 (~3900 patient-years of data in each group), pulmonary thromboembolism had occurred in 19 patients taking tofacitinib 10 mg twice daily and in 3 patients taking a TNF inhibitor; 45 patients taking tofacitinib 10 mg twice daily and 25 taking a TNF inhibitor had died. Interim data from the 5-mg twice daily group have not been made available by the FDA. After the interim analysis, patients taking the higher dose of tofacitinib were transitioned into the 5 mg twice daily group; the trial is ongoing.3
Serious, sometimes fatal thromboembolic adverse events have also occurred with use of baricitinib (Olumiant),4 another JAK inhibitor that is FDA-approved for treatment of RA. Whether an increased risk of thromboembolism is a class effect of JAK inhibitors remains to be determined; RA itself has been associated with an increased thromboembolic risk.5
The tofacitinib package insert now contains a boxed warning describing the increased risk of thrombosis and mortality with a dosage of 10 mg twice daily and emphasizes that this dosage or Xeljanz XR 22 mg once daily is not recommended for treatment of RA or psoriatic arthritis. For treatment of ulcerative colitis, tofacitinib is now only indicated in patients who have had an inadequate response or intolerance to TNF inhibitors; for these patients, the 10-mg twice daily dosage is still recommended as induction therapy for 8 weeks (can be continued for up to 16 weeks) and for maintenance treatment when there is loss of response to a dosage of 5 mg twice daily.
Download complete U.S. English article
In the postmarketing trial, RA patients ≥50 years old taking methotrexate who had at least one cardiovascular risk factor were randomized to receive add-on treatment with tofacitinib 5 mg twice daily (the FDA-approved dosage for RA and psoriatic arthritis), tofacitinib 10 mg twice daily (an approved dosage for ulcerative colitis), or a tumor necrosis factor (TNF) inhibitor. At the time of the interim analysis in January 2019 (~3900 patient-years of data in each group), pulmonary thromboembolism had occurred in 19 patients taking tofacitinib 10 mg twice daily and in 3 patients taking a TNF inhibitor; 45 patients taking tofacitinib 10 mg twice daily and 25 taking a TNF inhibitor had died. Interim data from the 5-mg twice daily group have not been made available by the FDA. After the interim analysis, patients taking the higher dose of tofacitinib were transitioned into the 5 mg twice daily group; the trial is ongoing.3
Serious, sometimes fatal thromboembolic adverse events have also occurred with use of baricitinib (Olumiant),4 another JAK inhibitor that is FDA-approved for treatment of RA. Whether an increased risk of thromboembolism is a class effect of JAK inhibitors remains to be determined; RA itself has been associated with an increased thromboembolic risk.5
The tofacitinib package insert now contains a boxed warning describing the increased risk of thrombosis and mortality with a dosage of 10 mg twice daily and emphasizes that this dosage or Xeljanz XR 22 mg once daily is not recommended for treatment of RA or psoriatic arthritis. For treatment of ulcerative colitis, tofacitinib is now only indicated in patients who have had an inadequate response or intolerance to TNF inhibitors; for these patients, the 10-mg twice daily dosage is still recommended as induction therapy for 8 weeks (can be continued for up to 16 weeks) and for maintenance treatment when there is loss of response to a dosage of 5 mg twice daily.
- FDA drug safety communication: FDA approves boxed warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR). July 26, 2019. Available at: www.fda.gov. Accessed August 15, 2019.
- Tofacitinib for rheumatoid arthritis. Med Lett Drugs Ther 2013; 55:1.
- FDA drug safety communication: Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. February 25, 2019. Available at: https://www.fda.gov. Accessed August 15, 2019.
- Baricitinib (Olumiant) for rheumatoid arthritis. Med Lett Drugs Ther 2018; 60:120.
- IC Scott et al. Thromboembolism with Janus kinase (JAK) inhibitors for rheumatoid arthritis: how real is the risk? Drug Saf 2018; 41:645.
Download complete U.S. English article
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).
Expanded Table: Biologic Agents for Rheumatoid Arthritis (online only)
The Medical Letter on Drugs and Therapeutics • July 30, 2018; (Issue 1552)
...
View Expanded Table: Biologic Agents for Rheumatoid Arthritis
Baricitinib (Olumiant) for Rheumatoid Arthritis
The Medical Letter on Drugs and Therapeutics • July 16, 2018; (Issue 1551)
The FDA has approved the Janus kinase (JAK) inhibitor
baricitinib (Olumiant – Lilly) for oral treatment of adults
with moderately to severely active rheumatoid arthritis
(RA) that has not responded...
The FDA has approved the Janus kinase (JAK) inhibitor
baricitinib (Olumiant – Lilly) for oral treatment of adults
with moderately to severely active rheumatoid arthritis
(RA) that has not responded adequately to one or more
tumor necrosis factor (TNF) inhibitors. Baricitinib is
the second JAK inhibitor to be approved for treatment
of RA; tofacitinib (Xeljanz, Xeljanz XR) was the first.