ORLANDO (FRONTLINE MEDICAL NEWS) – Omalizumab, a monoclonal anti-IgE antibody, may be a good option for patients with treatment-refractory bullous pemphigoid.

Patients who received omalizumab (Xolair) experienced rapid improvements, with 30%-50% lesion clearance within a week and complete clearance by 3 weeks, Kenneth Yu, MD, said at the annual meeting of the American Academy of Dermatology. With regular injections, they were kept symptom free for months. Some patients did flare, but were then easily controlled on standard treatment. Omalizumab , approved by the Food and Drug Administration in 2003, is indicated for moderate to severe persistent asthma and chronic idiopathic urticaria.

“We have now treated six patients with omalizumab with very good results with five of them. These are not your garden-variety BP patients, but people with very treatment-resistant disease who have failed treatment with corticosteroids alone, and in combination with other immunosuppressants.”

The rapid clinical improvements, along with observations that eosinophilia decreased with treatment, “strengthen the evidence that BP is an IgE-mediated, organ-specific autoimmune disease,” said Dr. Yu , senior resident in dermatology at the University of Michigan, Ann Arbor.

“Would I use this as a first-line treatment for BP? Probably not. But if you are seeing someone who’s nonresponsive to therapy, you might want to check IgE and eosinophil levels and if those are elevated, you might consider omalizumab as an adjunct treatment – and you might observe a fairly dramatic response.”

Three of Dr. Yu’s patients received omalizumab as monotherapy, and three received it in conjunction with other immunosuppressants. He described their disease presentation, treatment, and progression.

In general, Dr. Yu reserves omalizumab for patients with refractory disease and two particular clinical characteristics: high eosinophil count and elevated serum IgE. The initial dosing is based on the asthma treatment nomogram for the drug; he titrates it according to clinical response. “We don’t alter the total dose given, but we do adjust the frequency with which we give it.”

His first patient was a 70-year-old woman with a 1-year history of poorly controlled BP; she had failed prednisone, azathioprine, and minocycline. She also had a history of steroid-related vertebral compression fractures. She presented with an eosinophil count of over 400 cells/microL.

“We treated her with subcutaneous injections of 300 mg every 2 weeks for 16 weeks,” Dr. Yu said. Within 1 week, she had a 44% reduction in blisters; within 4 weeks, she had gone from 50% body surface area involvement to 5%.

After eight injections, the patient was disease free and Dr. Yu discontinued treatment. She remained clear until week 32 after treatment initiation; she had a flare manifested by increased pruritus and recurrence of lesions. Dr. Yu restarted omalizumab and the lesions cleared within 2 weeks. From weeks 35-72, the patient received five more injections and remained disease free.

“After that, she did have another flare, so we used omalizumab again,” but without the same excellent results. “She had an initial decrease in pruritus, and symptom improvement, but her disease subsequently worsened. We restarted her on prednisone and azathioprine and she has done well.”

Dr. Yu said he made “a couple of interesting observations on this case.”

“We saw no real correlation between disease activity score, and the levels of serum IgG antibodies. But we did notice a parallel correlation with the level of eosinophil and disease severity and also treatment response,” he said. “It was quite clear that immediately after injection, she had a dramatic drop in eosinophils” from 1,600 to 60 cells/microL within 24 hours.

His next case was a 72-year-old woman with a history of somewhat controlled essential tremor, and 6 months of highly pruritic BP blistering. She had been treated with 60 mg/day prednisone, but didn’t tolerate it well, developing steroid-induced psychosis with agitation and violence, and a worsening of her tremor. The steroid was tapered to 40 mg/day and azathioprine was added, but she was did not respond to this change and continued to develop new blisters each day. She was admitted to the hospital for plasmapheresis, which was not helpful. Nor did she respond to six cycles of cyclophosphamide.

At that point, Dr. Yu drew IgE and eosinophil levels: Her absolute eosinophil count was 1,600 cells/microL and IgE was 287 units/mL. He then gave the patient 300 mg omalizumab subcutaneously.

“Ten days after a single injection, her blisters had almost completely resolved,” he said. “To briefly describe her disease course, the blisters went away, and she had resolution of her pruritus. She was discharged with 1 month of prednisone, but we tapered that and have been able to maintain her on omalizumab alone. She had one mild flare, which was readily controlled with prednisone. The last time we saw her, she was disease free.”

He also described four other steroid-refractory BP patients treated with omalizumab.“Their commonalities were that they all had steroid-refractory disease that was resistant to immunosuppressants, had a high level of IgE, and most of them also had eosinophilia.”

Dr. Yu’s descriptions:

• A 78-year-old woman with refractory BP of 1.5 years responded well to three initial injections spaced 6 and 4 weeks apart, and has been well maintained for 20 months with 300-mL injections administered once a month. One relapse was easily controlled.

• A 72-year-old woman with 3.5 years of refractory BP responded well to 375 mg injections every 4 weeks and has been symptom free for a year on that maintenance dose.

• A 55-year-old woman with a 7-month history of refractory BP experienced a 30% reduction in body surface area blistering within 1 week of her first 375-mg injection. By 3 weeks, she was clear. She had three injections, 2 weeks apart, and was disease free for 3 months.

• An 86-year-old woman with longstanding refractory BP experienced a 22% reduction in blister count within a week of her first 375-mL injection. After a series of injections every 2 weeks, however, she developed an exacerbation of her preexisting chronic obstructive pulmonary disease, which was due primarily to tapering her prednisone. However, she no longer uses omalizumab.

“It is difficult to make recommendations because of the limitations of our data,” Dr. Yu said. “But based on the small number of patients we have treated, I would consider using omalizumab in patients with resistant disease who have an elevated IgE and eosinophil count. The optimal dosing regimen is not yet determined. Our approach is to start out with the asthma dosing and titrate until we see improvement. We use the highest dose indicated for the patient’s weight and IgE levels, typically 300-375 mg subcutaneously every 2-8 weeks, and start tapering when the patient gets control.”

He had no financial disclosures.

On Twitter @Alz_Gal


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