HUMIRA is a pharmacy that serves as its primary caregiver as a subcutaneous biological treatment for pediatric patients from 5 years of age with active ulcerative colitis.
Agencia Latina de Noticias Medicina y Salud Pública
The Federal Administration of Drugs and Food of the United States approves HUMIRA for the treatment of moderate-grade ulcerative ulcerative colitis to be seen in pediatric patients of 5 years and years, can be used in 11 indications, of which 5 are included.
In a communication confirmed that this approval is based on the results of the basic (pivotal) study of phase 3, ENVISION I, the same demonstration that the highest dose of HUMIRA induces clinical remission in 60 per cent of patients per week 8 and that 45 per cent of the patients who respond to the week 8, increase the remission for the week 52.
HUMIRA is currently approved in the United States for use in 11 indications, including 5 approvals in the pediatric population.
“Ulcerative colitis can have a profound effect on patients and for a long time treatment options for pediatric patients are limited,” said Brandee Pappalardo, vice president and director of medical immunology at Abb..
“With this approach, the first and only biological subcutaneous test for pediatric patients with ulcerative colitis can be administered. This is a new indication of HUMIRA demonstrating AbbVie’s compromise with patients who need inflammatory bowel disease and refusing our method of reducing the burden that represents this disease for patients ”.
This approval is supported by the results of the Phase 3 Fundamental (pivotal) study program, which will demonstrate that HUMIRA will increase the compression criteria for clinical remission following the Mayo Parcial Point.
Ulcerative colitis is characterized by inflammation of the intestinal gut with sinuses as much as intestinal urgency as well as intestinal incontinence which fluctuates from liver to blood as well as loss of weight and weight. This is because it is a life-affirming disease that is not adequately monitored in many patients, which implies the need for more treatment options.
The results of the study demonstrated that 60 per cent of patients receiving the highest dose of HUMIRA increased the clinical remission following the PMS (premenstrual syndrome), to finalize the induction period of 8 weeks and 43% of patients in the group of the most common dose. For week 52, between week 8 responders to PMS, 45% of patients receiving the highest dose of HUMIRA will receive the FMS remission and 29% of patients receiving the highest dose of HUMIRA and 33% of the ‘on-the-spot’s. There are limitations on the interpretability of the dates of the placebo debit to the tamaño of the sample.
In the study ENVISION I, no new security signals will be observed for HUMIRA 1,2. At the height of any exposure to HUMIRA during the study, 22.6% of patients presented a serious adverse event.
The operation of this treatment reduces signs and symptoms of:
Rheumatoid arthritis (AR) from moderate to severe in adults. HUMIRA can be used alone, with methotrexate or with other specific drugs. HUMIRA can provide a mayor’s day to the houses and articles and can help in his ability to carry out diary activities.
Juvenile idiopathic arthritis (AIJ) poliarticular of moderate to severe in 2 years and mayors. HUMIRA can be used alone or with methotrexate.
- Psoriatic arthritis (APs) in adults. HUMIRA can be used alone or with other specific medicines. HUMIRA can provide a mayor’s day to the houses and articles and can help in his ability to carry out diary activities.
- Ankylosing spondylitis (EA) in adults.
- Moderate hydradenitis of moderate to severe in 12 years and mayors.
- To treat Crohn’s disease (EC) moderately only in adults and children of 6 years and mayors.
To treat ulcerative colitis (CU) from moderate to severe in adults and children of 5 years and mayors. It is not known if HUMIRA is effective in people who should not respond to the TNF blockers.
Placental chronic psoriasis (Pp) is severely severe in adults who may receive systemic or phototherapy therapy, and is receiving attention from a physician who may decide whether other systemic therapies are appropriate.
The uveitis intermedia (part of the ojo media), posterior (part of the oracle part) and the panuveitis (all parts of the ojo) have no infections in adults and children of 2 years and mayors. Common human effects of HUMIRA include reactions in the area of the injection (pain, enuresis, eruption, hinchazon, pimple or moretones), infections of the superior respiratory tract (sinusitis), pain of the head, eruption and nausea These are not all possible HUMIRA secondary effects. Déjale saber a su medico presents present some secondary effects molesto or not disappear.
Recover to his immediate medicine if he presents an infection or symptoms of an infection, between them:
- Fever, sudores or escalators
- Dolores muscular
- Tos
- Lack of alignment
- Flema con sangre
- Peso loss
- Lags on the skin tibias, redness or pain
- Diarrhea or abdominal pain
- Quemazón al orinar
- Get more frequent from the normal
- Sensation of a lot of singing
This is the most important information you need to know about HUMIRA. For more information, contact your medical professional.