Wednesday, June 1, 2011

New Johnson & Johnson Drug - Stelara Helping Crohn's Disease Patients

Johnson & Johnson's Stelara helped a significantly higher percentage of Crohn's disease sufferers than those who received a placebo, according to a study of patients who had not been helped by other commonly used drugs.

In addition, nearly 70 percent of patients who stayed on Stelara beyond the initial six weeks of the mid-stage study continued to respond to the drug and there was a significantly higher rate of remission at 22 weeks than in a placebo group.

Stelara, known chemically as ustekinumab, is already approved to treat the skin condition plaque psoriasis and is in late-stage testing for psoriatic arthritis. An approval for Crohn's would give the drug entry into an estimated $1.3 billion U.S. market and $2.7 billion market worldwide.

The intravenous biotech drug met the primary goal of the study as almost 40 percent of patients who received the 6 milligrams per kilogram of weight dose of Stelara achieved a clinical response -- defined as a 100-point reduction in the Crohn's Disease Activity Index (CDAI) -- after six weeks of treatment.

That compared with a response rate of 23.5 percent of patients who received a placebo.

Two lower doses of Stelara were also tested in the study of 526 patients with moderate to severe Crohn's disease who were not helped by, or could not tolerate, treatment with a widely used class of drugs known as TNF antagonists, such as Abbott Laboratories' Humira.

Those who received 1 mg/kg had a 36.6 percent response rate and the 3 mg/kg dose led to a 34.1 percent response rate.

"To see these kind of outcomes, where you have high response rates in the short term and then good remission rates out toward five or six months of therapy, it shows unequivocally that the drug is effective for treating Crohn's disease," said Dr. William Sandborn, the study's lead investigator, who presented the data at the Digestive Disease Week meeting in Chicago on Sunday.

"It's effective in the patient population that has the greatest unmet need at this point in time," Sandborn said of patients who do not respond to anti-TNF drugs.

He said a 100-point drop in the CDAI was clinically meaningful to patients. "They'll feel measurably better."

"The patient population was really quite ill and had very high disease activity, and despite that we saw nice response rates," Sandborn said.

In a second phase of the study, those who responded to Stelara after six weeks of treatment were given either a 90-mg injection of Stelara at week eight and week 16 or a placebo.

After 22 weeks, 69.4 percent of the Stelara patients maintained a clinical response and 41.7 percent were deemed to be in clinical remission. That compared with 42.5 percent who maintained a clinical response and a 27.4 percent remission rate in the placebo group.

Clinical remission was defined as a CDAI score down to 150. Patients in the study on average started at 320 or 325 on the CDAI scale, researchers said.

Crohn's is a chronic autoimmune disorder of the gastrointestinal tract that affects an estimated 700,000 Americans. Common symptoms are abdominal pain and diarrhea, and it can lead to bowel perforations. Many Crohn's patients require surgery when medicines no longer control symptoms.

The rate of infections and other serious side effects was similar in the Stelara and placebo groups, researchers said.

"We'll need more patients and longer-term data to really fully characterize the safety profile in Crohn's disease, but so far so good," Sandborn said.

Read more about Stelara for Crohn's Disease:

Humira Causes Vision Problems - Abbot and Humira Face Lawsuit

Hmm, I took a lot of Humira for Crohn's Disease, and my eyes are much worse now than they were back in 2008. Maybe I should look into this!

Abbott Laboratories faces a product liability lawsuit over Humira, their blockbuster arthritis and Crohn’s Disease drug, which was filed by a woman who alleges that she has developed optic nerve damage and permanent vision problems from Humira.

The Humira lawsuit was filed by Jamie Bixby in the U.S. District Court for the Northern District of Illinois on May 20, 2011.

Bixby alleges that side effects of Humira caused her to develop optic neuritis, an inflammation of the optic nerve that has left her with permanent impairment to vision in her left eye and a future risk of other nerve problems, including multiple sclerosis or loss of vision in her other eye.
Humira (adalimumab) is a “biologic” drug, which is part of a class of medications known as TNF blockers or tumor necrosis factor blockers. The medication was launched by Abbott Laboratories in 2003 for treatment of rheumatoid arthritis, but was subsequently approved for other indications, including treatment of Crohn’s Disease.

According to allegations raised in the complaint, Abbott downplayed the potential risk of Humira vision problems, despite the fact that information was available to establish notice that the drug may increase the risk of optic neuritis and other nerve damage from central nervous system (CNS) demyelination.

Bixby began using Humira in April 2008 for treatment of Crohn’s Disease, after her doctor suggested that the medication may be a better option than the long-term use of the steroid prednisone, which had been managing her symptoms. No warnings were provided on the drug label or prescription information that Humira may cause permanent damage to her vision at the time she began taking the medication.

In May 2008, Bixby indicates that she began experiencing severe headaches and pain in her left eye, which led her to call the toll free number provided with her Humira packet to ask if the problems may be related to the use of Humira. According to allegations contained in the complaint, Abbott’s nurse told her that eye pain was not related to Humira and suggested she contact her physician.

When Bixby contacted her doctor, she was told by the doctor’s office that they were unaware that eye problems were a known issue with Humira and scheduled an appointment for the following week. However, the next day Bixby noticed that the vision in her left eye became blurry with blacked out areas, causing her to leave work and seek immediate medical attention at an eye clinic.

Bixby was diagnosed with optic neuritis from Humira in both eyes, though she only experienced vision problems in her left eye. Following her diagnosis, Bixby was admitted for inpatient treatment to receive 4 days of intravenous steroids.

“Unfortunately, because Abbott had not adequately warned Ms. Bixby or her physician about the risk of optic neuritis, the diagnosis and treatment came too late to prevent permanent vision impairment for Ms. Bixby,” the complaint states.

Bixby previously worked as a web designer, and claims that she continues to suffer from headaches and eye pain that impact her ability to look at a computer screen for significant periods of time. She also continues to suffer blurry vision and black holes in the vision from her left eye, and has extreme light sensitivity and changes to her depth perception that affect her ability to drive or ride a bike.

Plaintiff alleges that Abbott downplayed the risk of Humira side effects, including the risk of Central Nervous System (CNS) demyelination, which can cause optic neuritis, transverse myelitis, multiple sclerosis or other nerve problems.

Crohn's Disease Blog