Celgene arthritis drug appears effective, safe after 1 year -study

Reuters

By Bill Berkrot

Oct 26 (Reuters) - Previously untreated patients experiencedsignificant and lasting reductions in signs and symptoms ofpsoriatic arthritis when given Celgene Corp's experimental oral drug, apremilast, according to data from alate stage clinical trial.

Patients taking either the 20 milligrams or 30 mg dose ofapremilast twice a day had a statistically significantimprovement in symptoms, such as painful, swollen joints, after16 weeks of treatment compared with those who received aplacebo, researchers said.

Signs and symptoms of the painful disease continued toimprove on apremilast through a year of treatment, according todata to be presented next week at the American College ofRheumatology meeting in San Diego.

If approved, apremilast will compete with injected biotechmedicines that have proved to be highly effective, but have moreserious potential side effects, such as opportunistic infectionsand tuberculosis because the biologics suppress the immunesystem.

"Psoriatic arthritis can be one of the most crippling typesof arthritis that we see," said Dr. Alvin Wells, the lead investigator of the 527-patient study who will present the data at the ACR meeting on Tuesday.

"To be able to have a patient that can take a pill twice aday, I think this is going to be a game changer, not only for meas a physician, but for my patients. They're going to have a newtreatment option," added Wells, director of the Rheumatology andImmunotherapy Center in Franklin, Wisconsin.

The U.S. Food and Drug Administration is expected to make andecision on the drug in March.

Celgene has said sales of apremilast could reach $1.5billion by 2017. Wall Street analysts' projections have beenmore modest, with RBC Capital Markets forecasting sales of $1billion in 2017, while Cowen and Co sees annual sales reaching$475 million in 2018.

The primary goal of the study dubbed Palace 4 was a 20percent reduction in signs and symptoms of the disease, known asACR20, after 16 weeks versus placebo.

At that point, 29.2 percent of those who got the 20 mg doseand 32.3 percent to took 30 mg achieved ACR 20, compared with16.9 percent on placebo.

After 52 weeks on the drug, 53.4 percent on the lower doseand 58.7 percent on the higher dose achieved an ACR20 response.

"These patients are on drug a long time so I want to seethat it's going to last," said Wells, calling the results "apretty dramatic response."

Placebo patients who did not respond early in the trial wereswitched to apremilast. By week 24 there were no longer anypatients receiving placebo, Wells explained.

Researchers also looked at how many patients experiencedimprovements of 50 percent and 70 percent.

At 52 weeks, for those on the higher dose of apremilast,31.9 percent had achieved ACR50 and 18.1 percent ACR70,researchers said.

About 125 million people worldwide suffer from the scalyskin condition psoriasis and about 30 percent of them candevelop psoriatic arthritis, a chronic, progressive disease inwhich joints become swollen and inflamed.

Apremilast is the first drug in a new class of medicinecalled PDE4 inhibitors.

"It inhibits an enzyme involved in making all these angryproteins that get into the skin, causing psoriasis, and theyalso get into the joints, causing arthritis," Wells said.

The most common side effects with apremilast were diarrhea,nausea and headache. No more serious adverse side effects werereported, and fewer than 2 percent of patients in the studydiscontinued treatment due to side effects.

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