NEW ORLEANS - Thalidomide is an effective and, when used judiciously, a reasonably safe second-line therapy for cutaneous lupus erythematosus, according to Dr. Jeffrey P. Callen, professor of medicine and chief of dermatology at the University of Louisville (Ky.).
"Thalidomide works regularly," Dr. Callen said at the annual meeting of the American Academy of Dermatology.
Hydroxychloroquine has to be considered first-line therapy for cutaneous LE because the antimalarials are disease modifying; their early use can prevent progression from strictly cutaneous disease to systemic lupus.
In contrast, thalidomide (Thalomid) doesn't modify the disease process. Once patients discontinue the drug, they relapse. And thalidomide doesn't have a marked effect on concomitant SLE. But upon readministration of thalidomide after a break, physicians can expect a clinical response similar to that seen earlier, he said.
Dr. Callen added that in patients who can't tolerate or don't respond to antimalarials, his next thought is thalidomide – ahead of immunosuppressive agents including methotrexate, azathioprine, and mycophenolate mofetil. Systemic corticosteroids are reserved for last-ditch therapy in his therapeutic algorithm.
Because of thalidomide's notorious teratogenicity, participation in the Food and Drug Administration–mandated System for Thalidomide Education and Prescribing Safety is required.
"Once you've selected an appropriate patient, the major issue then becomes, are they going to develop a neuropathy? I think with very low doses used every other night, you can get away with long-term therapy without developing neuropathy," he said. "I personally do not get nerve conduction studies. I follow the patients, and if they tell me they have symptoms that sound like sensory neuropathy, I stop the drug whether their nerve conduction study is positive or not."
In numerous published series, the majority of cutaneous LE patients placed on thalidomide achieved a complete response, with another 15%-20% attaining a partial response, and 15%-20% being nonresponders or encountering unacceptable toxicity, according to the dermatologist.
The clinical response to thalidomide begins quickly, within about 2 weeks at a dose of 100 mg/day. A full clinical response is achieved in 2-3 months. At that point the patient can shift to maintenance therapy, which might range from 50 mg/day to 25 mg every second or third day.
To place thalidomide in context, Dr. Callen said that the very first thing he does in managing cutaneous LE is remove any exacerbating factors. Topping the list is sunlight, which he addresses by means of daily use of a broad-spectrum sunscreen, sun avoidance, and sun-protective clothing.
In smokers with any form of lupus, the response to medications, especially antimalarials, is significantly improved by quitting the habit.
"It has been shown that smoking doesn't affect blood levels of antimalarials [Ann. Rheum. Dis. 2007;66:1547-8], so I think that the effect of smoking is probably to worsen the disease rather than in some way impede the antimalarial," Dr. Callen said.
A careful drug history is important, especially in patients with subacute cutaneous LE, whose lesions turn out to be drug related in about 20% of new cases.
The treatment goals in patients with cutaneous LE are to halt formation of new lesions in order to prevent scarring, atrophy, and dyspigmentation. New patients can be reassured that it's likely their disease will remain limited to the skin. "It doesn't mean it's not possible they have systemic disease, but they generally don't," the dermatologist said.
Dr. Callen said he had no relevant financial disclosures.