Index · Artikel · Takeda drug impresses in ulcerative colitis study

Takeda drug impresses in ulcerative colitis study

2012-05-22 6
   
Advertisement
résumén">More than 40 percent of patients with moderate to severe ulcerative colitis achieved clinical remission from the debilitating condition after a year of taking an experimental drug developed by Japan's Takeda Pharmaceutical Co, according to data
Advertisement

Takeda drug impresses in ulcerative colitis study


n">More than 40 percent of patients with moderate to severe ulcerative colitis achieved clinical remission from the debilitating condition after a year of taking an experimental drug developed by Japan's Takeda Pharmaceutical Co, according to data from a pivotal late-stage trial.

The biologic drug, vedolizumab, met the goals of the Phase III trial with highly statistically significant advantages in rates of remission, clinical response and bowel healing compared with a placebo, researchers said.

Of the patients taking part in the year-long maintenance study, 44.8 percent of those who received vedolizumab every four weeks and 41.8 percent who got the drug every eight weeks were deemed to be in clinical remission at week 52. That compares with 15.9 percent for those who received a placebo.

In a subset of patients who were not also taking a steroid for the condition, the remission rate was 45.2 percent for those who got the Takeda drug every four weeks compared with 13.9 percent in the placebo group.

"The maintenance study data are really spectacular," said Dr Brian Feagan, the trial's lead investigator who presented the data on Tuesday at the Digestive Disease Week meeting in San Diego.

"I think this is a pretty exciting result and has big implication for patient care ultimately," added Feagan, who said he believes the data to be strong enough for the drug to gain approval.

Clinical remission was defined as a score of 2 points or less on the 12-point Mayo scale of disease activity. A Mayo score of 6-12 indicates moderate-to-severe disease.

Ulcerative colitis is a chronic condition that affects roughly 700,000 Americans, and often strikes younger, active people. Common symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, fatigue and weight loss.

The ulcerative colitis market is expected grow nearly 6 percent annually to about $3 billion by 2020, according to a recent report from Decision Resources, which provides analysis of biopharmaceutical industry data.

Vedolizumab, which is given intravenously, belongs to a different class of biologic drugs than the TNF blockers widely used to treat colitis and other inflammatory diseases, such as Johnson & Johnson's Remicade and Abbott Laboratories' Humira. The drug targets a protein present in a small percentage of white blood cells that have been shown to play a role in controlling inflammation.

The anti-TNF drugs, while highly effective, suppress the immune system and have been associated with infections and other serious complications, such as tuberculosis.

"It would be nice to have a drug that didn't do that," Feagan said. "There was no increased risk of serious infection or any infection over placebo. It's pretty striking actually."

NO PML CLOUD

The Takeda drug works in a similar manner to Biogen Idec's multiple sclerosis drug Tysabri, which has been associated with a rare, potentially fatal brain infection known as PML. Feagan said vedolizumab is more selective and works on the gut and not the brain so is unlikely to carry a similar risk. "It should not have a PML cloud," Feagan said.

He said he expects the Takeda drug would initially be used after anti-TNF therapy stops working or in patients who cannot tolerate those drugs. But he believes it may eventually supplant TNF blocker therapy.

About 40 percent of those in the nearly 900-patient study had previously been treated with a TNF blocker, Feagan said.

In addition to remission rates, researchers looked at the rate of durable clinical response and bowel improvement, or mucosal healing, at week 52.

For those who received the Takeda drug every eight weeks, 56.6 percent had a durable clinical response, such as a significant easing of symptoms, as did 52 percent who got the drug every four weeks. That compared with 23.8 percent in the placebo group.

Clinical response was defined as a drop of 3 points on the Mayo scale, at least a 30 percent reduction in the overall score, and significant improvement in rectal bleeding.

The mucosal healing rate at week 52 was 51.6 percent for vedolizumab once every eight weeks and 56 percent for every four-week therapy, compared with 19.8 percent for placebo.

Patients in the study began with a six-week induction phase in which they got an initial 400 milligram dose of the drug to start and another 400 mg dose at week 2 before moving into the maintenance phase for the next 46 weeks.

(Reporting by Bill Berkrot in New York; editing by Matthew Lewis)

TOP

  • Day/
  • Week/
  • Original/
  • Recommand

Updated

  • Prostate cancer screening: More harm than good?

    Prostate cancer screening: More harm than good?
    CHICAGO Routine screening for prostate cancer has resulted in more than 1 million U.S. men being diagnosed with tumors who might otherwise have suffered no ill effects from them, U.S. researchers said on Monday. They said prostate cancer screening is
  • Ist felodipine niedriger Herzfrequenz, so dass es nicht proportional mit der Übung zu erhöhen? Wenn ja?

    ... Ist anstrengende Übung dann gefährlich Nehmer von Felodipin? Ich hatte eine funktionelle Kapazitätsauswertung durchgeführt und der Krankengymnast berichtet, dass mein Puls nicht während der Übungen zu erwartenden maximalen nicht zu einer Erhöhung
  • Startseite medizinische Geräte nächste Ziel für die FDA

    Startseite medizinische Geräte nächste Ziel für die FDA
    Die Food and Drug Administration hat eine neue Initiative mit dem Ziel, die Sicherheit von komplexen medizinischen Geräte von Patienten und Pflegepersonal im Haushalt zu verbessern. Die Bundes Aufpasser wollen die Zahl der unerwünschten Ereignisse im
  • Wie funktioniert Trazodon Arbeit auf das Gehirn Sie zu schlafen?

    Ich habe jeden Schlafmittel auf der Erde genommen. Ich habe schwere Schlaflosigkeit und ich ging sogar zu einem Schlaflabor & sagten sie mir, dass sie noch nie einen schlimmeren Fall gesehen hatte. Ich ging nie in den REM oder irgendwelchen Ebenen de
  • Türkei geformte Fun Foods

    Türkei geformte Fun Foods
    Türkei Shaped Foods Das Essen am meisten im Zusammenhang mit Thanksgiving ist der Truthahn. Es macht Spaß, Truthahn förmige Lebensmittel zu machen, damit die Kinder während dieser Zeit des Jahres zu essen. Einige dieser Lebensmittel Ihr Kind allein o
  • Wie verwendet Ihr Teen das Internet?

    Wie verwendet Ihr Teen das Internet?
    heute Teens nutzen das Internet, mehr als je zuvor als Quelle für Informationen und den Anschluss an andere. Sie nutzen es eine Welt jenseits ihrer physischen zu erstellen, ein soziales Netzwerk und Unterstützung an Orten bieten, wo sie persönlich fe
  • Zika PAYDAY! Obama will $ 1800000000 für die Impfstoff-Forschung Trichter und mehr

    Zika PAYDAY!  Obama will $ 1800000000 für die Impfstoff-Forschung Trichter und mehr
    Bis zum Jahr 2016 Zika war nicht sehr ernst von amerikanischen Behörden. Die entspannte Haltung schlug vor, dass es nur eine andere banale Krankheit in Ländern der Dritten Welt war. So viel war von der CDC die Haltung und das Fehlen von Empfehlungen
  • Ich beendete meine erste Packung von Jolessa und haben keine Zeit gehabt?

    Ich benutzte Seasonale (oder die allgemeine ... Jolessa, Quasense, etc.) vor Jahren zu nehmen und dann meine Versicherung lief. Ich habe es erst wieder in diesem Jahr. Ich hatte, ohne es zu 5 Jahre gewesen. Das erste Mal, dass ich es nahm, hatte ich
  • Tuberkulose-Behandlung

    Tuberkulose-Behandlung
    Tuberkulose ist eine miese Krankheit. TB gräbt weg Energie - und Atem. Einige haben permanent vernarbte Lungen; ihre Lungen heilen nie die Löcher. Einige haben Infektionen in ihre Wirbelsäule; andere TB in ihrem Bauch oder sogar um ihr Gehirn. Einige
  • Hörverlust in Teens Spikes Mysteriously

    Hörverlust in Teens Spikes Mysteriously
    Credit: stock.xchng Credit: stock.xchng Die Eltern der Jugendlichen haben ungezählte Alter beklagt, dass ihre Kinder nicht auf sie hören. Aber es könnte sein, dass die Jugendlichen heute nur sie nicht hören, körperlich. Hörverlust bei Jugendlichen ha