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Know How to Steer Fast Biologics


 

FROM A DERMATOLOGY SEMINAR SPONSORED BY SKIN DISEASE EDUCATION FOUNDATION

LAS VEGAS – If you think of biologic therapies for psoriasis as cars, some are sturdy but pedestrian while others are racy sports cars.

"Etanercept is like a Volvo. It’s not a fast car, it’s not a flashy car, but it’s a good, solid car that will probably work for you. Some of the other biologics are more like Ferraris – very fast but more difficult to steer," Dr. Francisco A. Kerdel said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Photo credit: Thomas Doerfer/Wikimedia Commons

Etanercept is like a Volvo, but infliximab is like a Ferrari, according to Dr. Francisco A. Kerdel.

Infliximab would be a Ferrari. "This is a high-performance vehicle, but you need to know what you’re doing," said Dr. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Golimumab is "like one of those European cars that look fantastic, but you’re probably never going to own one," he said. Dr. Kerdel believes that golimumab probably will not win an indication specifically to treat psoriasis. It is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

He offered several driver’s tips for getting the best performance out of infliximab.

Unlike the other biologics, infliximab is administered intravenously. It’s "very, very efficacious and very fast" for treating psoriasis, he said. With the 5-mg/kg dose being marketed, 56% of patients achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 6 weeks in a phase III clinical trial. By week 10, 57% achieved a PASI 90.

Because infliximab is given on a mg/kg basis, the patient’s weight doesn’t seem to have as much effect on responses. Improvements are similar in patients who are normal weight, overweight, or obese.

Approximately 4% of patients receiving infliximab develop infusion reactions, compared with 2% who get placebo infusions. "The vast majority of these reactions are mild, and they can be managed in the office," Dr. Kerdel said. Less than 1% of patients will develop an infusion reaction severe enough to stop the drug.

Infusion reactions are more common in patients who receive episodic treatment (regardless of dose), making them more likely to develop antibodies to infliximab. Sticking to scheduled infusions every 8-10 weeks reduces those risks.

Tell patients to fasten their seat belts and prepare for a regular commute. "Adherence to this therapy is very, very, very important," Dr. Kerdel said. "In those patients in whom you are considering this agent, you have to explain to them that they have to come for their scheduled visits."

Patients who keep to the every-8-weeks maintenance schedule after induction are less likely to have undetectable serum concentrations of infliximab when they return for treatment and more likely to respond to treatment. "Even though the drug is approved for every 8 weeks after the initial induction phase, some patients may have to receive the infusions every 4 or 6 weeks. The interval may have to be shortened for them to get an adequate response," he said.

If psoriasis relapses during long-term maintenance therapy with infliximab, repeating the induction phase may help, a small retrospective study suggests. Of 22 patients who lost their PASI 50 response and underwent re-induction, 20 regained a PASI 50 and 9 achieved a PASI 75 (Dermatol. Ther. 2010;23:199-202).

Keep safety in mind from the start, Dr. Kerdel said. Infliximab is contraindicated in patients with sepsis or serious infections. Get a tuberculosis skin test before starting infliximab and every year thereafter. Take precautions for patients with demyelinating disorders, congestive heart failure, liver function test abnormalities, or hepatitis B.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel has been an adviser or speaker for, or has received grants from, Centocor Ortho Biotech (which markets infliximab and golimumab), Amgen (which markets etanercept), Abbott, Merck, Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth.

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