Adalimubab - Humira

[edi]

Czy ktoś coś słyszał na temat tego leku a na forum nie znalazłem nic na jego temat albo nie umiem szukać

[edi]

właśnie taką nazwę mam zapisaną też szukałem w gogle i nic jest to lek biologiczny testowany w st.zjed. Jest to lek działający jak infliksimab tylko nie jest to białko mysio ludzkie lecz tylko ludzkie

[Misia]

treść wpisu została usunięta na prośbę użytkownika

[Maciek]

Mamcia mówi: Adalimubab - Humira. Cłakowicie ludzki TNF-alfa.
Tak kazała przekazać

[Misia]

treść wpisu została usunięta na prośbę użytkownika

[Szaraja]

Dobrze, że Mamcia chociaż czyta, szkoda, że nie pisze. Mam nadzieję, że niedługo zawita na forum, bo brakuje.
Pozdrawiam
Szaraja

[Misia]

treść wpisu została usunięta na prośbę użytkownika

[edi]

Bardzo dziękuję za sprostowanie nazwy teraz już mogę sam coś znależć na temat leku

[Mamcia]

Oto nowe badania nad adalimumabem.
http://www.medscape.com/viewarticle/546904?src=mp
może ktoś przetłumaczy, lub streści
Mamcia

-Ania- edit
Treść artykułu:

October 31, 2006 (Las Vegas) --- Patients with moderate to severe
Crohn's disease who have stopped responding to infliximab (/Remicade/)
or cannot tolerate the treatment may have a more positive response to
adalimumab (/Humira/), according to a team of investigators who
presented their findings here at the 71st annual meeting of the American
College of Gastroenterology.

Principal investigator William J. Sandborn, MD, presented the results of
the trial, Gauging Adalimumab effectiveness in Infliximab Nonresponders
(GAIN). He said that 52% of treated patients had a clinical response by
week 4 compared with 34% of those receiving placebo.

"The findings showed that patients who have developed resistance to
infliximab or who have developed a reaction to it can benefit from
adalimumab," Dr. Sandborn said during his presentation. "Adalimumab was
well tolerated, with only the adverse events that have previously been
seen in patients with Crohn's disease and rheumatoid arthritis." He is a
professor of medicine in gastroenterology at Mayo College of Medicine in
Rochester, Minnesota.

The GAIN investigators recruited 325 patients who had either stopped
responding to infliximab or had developed an allergic reaction to it;
166 patients were randomized to the placebo group, and 159 to the
treatment group. The patients all had moderate to severe Crohn's disease
(Crohn's Disease Activity Index [CDAI] scores ranged from 220 to 450).

The patients in the treatment group received 160 mg subcutaneously at
the beginning of the trial and 80 mg at week 2. The investigators
assessed patients' responses at weeks 2 and 4, with a primary end point
of clinical remission by week 4. Secondary end points included clinical
response, as defined by 2 levels: a reduction of the CDAI score of at
least 70 points, and a reduction of at least 100 points, as assessed at
weeks 2 and 4.

At week 2, a CDAI decrease of at least 70 points was seen in 82 patients
in the treatment group (52%) vs 55 patients (33%) receiving placebo (/P
/< .01). At that point, 58 adalimumab patients (36%) had had a reduction
of at least 100 points compared with 30 patients (18%) receiving placebo
(/P/ < .001). By week 4, reductions of at least 70 points were virtually
unchanged: 82 patients (52%) receiving adalimumab and 56 patients (34%)
receiving placebo. Decreases of at least 100 points were documented in
62 patients (38%) receiving adalimumab and 41 patients (25%) receiving
placebo (/P/ < .01).

At week 4, 34 adalimumab patients (21%) had achieved a CDAI score of
less than 150 compared with 12 placebo patients (7%; /P/ < .001).

There were few serious adverse events, occurring in 1.3% of those
receiving adalimumab and 4.8% of those receiving placebo. There were 3
abscesses and 1 case of sepsis in the placebo group. One patient each in
the placebo group had a flare of Crohn's disease, dehydration, and
abdominal pain. In the adalimumab group, 1 patient each had a disease
flare and dehydration. There were no delayed hypersensitivity reactions,
Dr. Sandborn said, and no deaths.

"The GAIN study shows that adalimumab is an effective treatment for the
difficult-to-treat group of Crohn's patients who have lost response to
infliximab," commented Richard Bloomfeld, MD, in an email. Dr.
Bloomfield, who was not involved in the study, is an assistant professor
of medicine at Wake Forest University School of Medicine in
Winston-Salem, North Carolina, where he is the director of the
Inflammatory Bowel Disease Clinic.

"Previously, it was bad news when a Crohn's patient in remission on
[infliximab] developed an infusion reaction," Dr. Bloomfeld added.
"There were few remaining options. The GAIN study has shown that we can
use [adalimumab] to get these patients back in remission."

Humira is manufactured by Abbott, which funded the study. Dr. Sandborn
has been a consultant for Abbott but is not otherwise financially
involved with the company.

[dzierzba]

znalazlem info na amerykanskiej stronie wyglada niezle kolejne zwiekszeie mozliwosci zostajepczywiscie kwestaia ceny dostepnosci przyslzosci leku Jednak warto widziec ze cos sie dzieje w tym kierunku U nas przy liczbie chorych to nie ma co liczyc ze NFZ bedzie wpsieral jakies badania zostaje nam zachod i USA a ze ni maja chorych w setki tysiecy a stany to z milion to jest hope ze bedzie coraz lepiej


NEW YORK (Reuters Health) - In Crohn's disease patients who respond to adalimumab, the agent is significantly more effective than placebo in maintaining remission for more than a year, according to French and North American researchers.

Adalimumab is a monoclonal antibody directed against tumor necrosis factor used in many inflammatory diseases.

As lead investigator Dr. Jean-Frederic Colombel told Reuters Health, "Adalimumab use weekly or bi-monthly effectively maintains clinical remission and response, steroid-free remission, and fistula closure in patients with moderately to severely active Crohn's disease."

As described in the January issue of Gastroenterology, Dr. Colombel of Centre Hospitalier Universitaire de Lille and colleagues studied 778 patients who had initially completed 4 weeks of therapy with adalimumab.

Of this group, 449 were deemed to be responders and 279 were classified as non-responders. They were stratified by response and all were randomized to subcutaneous treatment with adalimumab 40 mg weekly, adalimumab 40 mg every two weeks, or to placebo.

The current analysis focuses on outcomes of patients who were responders in the 4-week trial. At 26 weeks, 47% of responsive patients in the weekly treatment group and 40% of those in the two-weekly treatment group remained disease free. This was true of only 17% of the patients randomized to placebo. At 56 weeks, corresponding proportions were 41%, 36% and 12%.

No significant differences were seen in outcome between the adalimumab regimens, and the agent was well tolerated. In fact, 11.4% of placebo patients discontinued treatment because of adverse events compared to 4.7% of those with weekly treatment and 6.9% of those with twice-monthly treatment.

Summing up, Dr. Colombel added, "I hope that continued trials will confirm the strong tolerability profile of adalimumab and offer patients another reliable option to manage their symptoms."

[Mamcia]

jest to lek podobny do infliximabu, ale całkowicie ludzki, czli efekty niepożądane są mniejsze. Z mojej wiedzy, która ostatnio nie jesy up-dated wynika, że jest w trakcie rejestracji w USA i chyba w UE.
mamcia

[dzierzba]

zgubilem sie czytam o tym i czytam i wychodzi mi na to ze my to jestesmy leczeni odpadami ktore zostaja z leczenia ludzi z reumatoidalne zapalenie stawów przeczytajcie to i sami powiedzcie
http://www.esculap.pl/pogodzinach/recen ... 1779&type=

przeciez to te same leki taki sam rodzaj leczenia nie rozumiem tego moze ktos to potrafi mi wyjasnic oco tu chodzi wedle tego artykulu na choroby stawiw w samej polsce cierpi blisko 400 tys ludzi a nas to ile moze byc pomiedzy 02 a 0,5% ile osob choruje i nigdy nie przyjmowalo lekow nie bylo z tym u lekarza. moze sie kiedys okaze ze chorych jest mnostwo tylko ze jedynie pewna grupa ma objawy kwalifikujace sie do leczenia klinicznego. powiedzmy ze 100 tys max 10 tys a reszta bedzie zyla biorac rozne leki nie koniecznie na to na co naprawde sa chorzy. Narazie nie czytam wiecej otych lekach bo dojde do wniosku ze nikt nas nie leczy tylko probuja leki ktore im zostaja z leczenia innych chorob Ale jak ktos bedzie wiedzial ile kosztuje adalimumab (Humira) to bedzie milo moze bedziemy sobie robili zastrzyki jak na cukrzyce tyle ze co dwa tygodnie To by bylo piekne he he tylko pewnie cena by nas zwalila z nog gdzies znalazlem ze jden zastrzyk 800 euro.

[dzierzba]

a propo kosztow to ehh spojrzcie na to

Adalimumab (Humira™) < Print >


Date: 03/21/2003
Manufacturer: Abbott Laboratories

Adalimumab is a fully human monoclonal antibody specific for human tissue necrosis factor-alpha (TNF-a). TNF-a is a cytokine involved in inflammatory and immune responses. Adalimumab binds to TNF-a, preventing the migration of other proinflammatory factors into synovial fluid. Adalimumab is labeled for moderate to severe rheumatoid arthritis (RA) in adults not responding to other disease modifying anti-rheumatic drugs (DMARDs). Adalimumab may be used alone or in combination with methotrexate (MTX) or other DMARDs.

Adalimumab is given by subcutaneous injection, resulting in an average absolute bioavailability of 64%. Adalimumab synovial fluid concentrations are 31-96% of serum concentrations. Maximum serum concentrations are achieved 5 to 6 days after administration. The volume of distribution at steady state ranges from 4.7 to 6.0 L and the systemic clearance is 12 mL/hr. The mean terminal half-life is approximately 2 weeks.

Four randomized, double-blind, placebo-controlled studies assessed the safety and efficacy of adalimumab. These trials included study arms of adalimumab alone, adalimumab plus MTX and adalimumab plus other DMARDs. The American College of Rheumatology (ACR) criteria of clinical improvement and subjective measures of clinical improvement were significantly greater in patients treated with adalimumab compared to placebo in all 4 studies.

Adalimumab is generally well-tolerated, however, package labeling contains a black box warning due to the risk of serious infections, such as sepsis and tuberculosis. Patients with active infections should not use adalimumab. Patients on concomitant immunosuppressive therapy should use adalimumab with caution. The most common adverse reactions are erythema and pain at the injection site (20%).

Adalimumab is not associated with any significant drug interactions. Methotrexate may reduce the apparent clearance of adalimumab, however, no dose adjustments were necessary in studies with concomitant administration. No other drug interactions have been reported.

The recommended dose of adalimumab is 40 mg given by subcutaneous injection every other week. Adalimumab may be given weekly, possibly providing benefit to patients not on concomitant MTX. Patients must self-inject the full amount of fluid in the pre-filled syringe (0.8 mL), rotating the site with each injection. Adalimumab must be refrigerated and protected from light. Table 1 provides a cost comparison of adalimumab and other common RA treatments.

Table 1. Cost Comparison of Medications for Rheumatoid Arthritis

Drug Dose/Frequency Cost per Dose (AWP) Annual Cost (AWP)
Adalimumab (Humira®™) 40 mg SQ every 2 weeks $653.30 $15,679.20
Infliximab (Remicade®)* 3 mg/kg IV over 2 hours every 8 weeks (maintenance dosing) $691.61 $5,532.88
Etanercept (Enbrel®) 25 mg SQ twice weekly $163.33 $15,679.68
Anakinra (Kineret®) 100 mg SQ daily $43.73 $15,961.45
*A 100 mg vial of infliximab must be purchased for each dose and must be administered in an infusion center. The starting dose is 3 mg/kg at weeks 0, 2, and 6, then 3 mg/kg every 8 weeks thereafter
References

Humira™ (adalimumab) package insert. Chicago, Illinois: Abbott Laboratories, December 2002.
Drug Topics: The Red Book. Montvale, NJ: Medical Economics Co., 2003.
Written by Jaime Hendrickson, Pharm.D. Student. Edited by Sarah Feddema, Pharm.D., Drug Information Resident.

tabelka sie przestawila nieco ale roczne koszy to ta wyzsza suma wiecsa wielkie (

[Mamcia]

A ja nie rozumiem, czego nie rozumiesz? Że leczenie podobne do rzs - bo natura choroby podobna. jednym rzuca się na stawy, innym na nerwy, innym na tarczycę. badania zaczyna się rzs bo grupa największa i zysk najszybszy.
m

[dzierzba]

Nie wiedzialem ze to co dolega nam tak naprawde w roznych postaciach dotyka duzo wieksza grupe ludzi tylko objawy sa. Co do leku Humira coz nie daje on pewosci co do sukcesu leczenia ale 50% skutecznosci to i tak niezle to jest link do stony gdzie opisana jest dosc dokladnie skutecznosc leku i jak o stosowac
http://www.rxabbott.com/pdf/humira.pdf
mysle ze warto sie zainteresowac tym tematem co prawda lek jest dopiero 2 lata na rynku w stanach i wciaz badaja jaki wplyw ma jego dlugotrwale zastosowanie. Mi sie podoba latwosc uzycia aplikuje sie samemu nie trzeba lezec w szpitalu a wady coz infkecje i zakazenia to pierwsza szansa na zachorowanie na jakies paskudztwo rosnie 2-3 razy szczegolnie gruzlica. Druga wada to cena aby zobaczyc jak na nas dziala lek trzeba wzisc 4 dawki w ciagu 2 dni nastepnie 2 w kolejnym tygodniu i puzniej co dwa tygodnie 1 do 12 tygodnia razem 11 dawek razy 650 dolarow plus bilet do stanow zeby to kupic taniej hmm jakies 7,5tys $. Narazie to chyba zaduzo dla nas. Ale moze z czasem NFZ bedzie refundowal ten lek i nam