14 NEWS NOVEMBER 2009 • SKIN & ALLERGY NEWS Omalizumab Quelled Urticaria in 70% of Patients

BY BRUCE JANCIN type of urticaria, autoallergic. These are Drug Administration added a black box before omalizumab can earn an indica- patients with IgE antibodies directed to warning to Xolair, stating that patients tion for urticaria include its efficacy in B ERLIN — Omalizumab proved effec- thyroid peroxidase as an autoantigen. must receive injections under direct med- types other than autoallergic urticaria, tive and safe in patients with moderate A total of 27 patients were randomized ical supervision in a health care setting so the drug’s mechanism of action, and op- to severe chronic urticaria refractory to to omalizumab and 22 to placebo. Two they can be monitored for signs of ana- timal dosing. antihistamines in a double-blind, place- subjects in the phylaxis. Anaphy- Anecdotally, Dr. Maurer said that he bo-controlled, multicenter trial. omalizumab arm ‘This is definitely laxis has presented and his colleagues have successfully treat- Seventy percent of omalizumab-treat- dropped out dur- a drug to consider as bronchospasm, ed patients with antihistamine-refracto- ed participants were free of all symptoms ing the study peri- when you have hypotension, syn- ry spontaneous urticaria, cold urticaria, at 27 weeks, compared with 4.5% of od, as did five in patients who do cope, urticaria, and physical urticaria, cholinergic urticaria, placebo-treated controls. the control group, not respond’ to angioedema of the solar urticaria, pressure urticaria, and “For those of you who know urticaria mainly due to lack standard throat or tongue in other forms of the disease. and know how well drugs do in urticaria of response. treatment. patients receiving Audience members were quick to ask patients, I think this is absolutely amaz- Mean baseline as little as one dose about the cost, which is high. ing. There’s no other drug that can do score on an ur- DR. MAURER of the drug. “It’s about 500 euro [about $750] per in- this. Your favorite antihistamine can’t ticaria assessment Dr. Maurer laid jection, and these patients typically need achieve these levels. Plus, these are pa- scale was 25 out of a possible 42. At 6 out the patient numbers that make pur- one or two injections per month,” he tients who’ve already been on pretty months the score in the omalizumab suing an indication for omalizumab in replied. “But remember, these patients much everything else and didn’t re- group had dropped to 6, while remain- urticaria an attractive proposition. The suffer tremendously, they miss work, and spond,” Dr. Marcus Maurer said at the ing unchanged in the control group. The prevalence of urticaria in Europe is esti- the other drugs are not cheap either.” annual congress of the European Acad- omalizumab group also made signifi- mated at 1.3%, or more than 10 million In a congress highlights lecture devot- emy of Dermatology and Venereology. cantly less use of rescue antihistamines. individuals. Three-quarters of them have ed to new develeopments in skin allergy, “This is definitely a drug to consider Response to omalizumab occurred chronic spontaneous urticaria and one- Dr. Torsten Zuberbier singled out the when you have patients who do not re- rapidly, within the first several weeks. quarter have inducible urticaria. The omalizumab study, noting that its symp- spond to your standard urticaria treat- “It’s very different from asthma patients, only drugs licensed for the treatment of tom-free rate of 70% is “fascinating.” ment,” added Dr. Maurer, a dermatolo- who take a couple of months to re- urticaria are antihistamines, and an esti- “Now the biologics are coming to der- gist at Charité University Hospital, Berlin. spond,” Dr. Maurer said. mated 5.7 million Europeans with ur- matological allergy, and we’re really go- Omalizumab (Xolair, Genentech/No- There were no omalizumab-related ticaria are not adequately controlled on ing to start to learn more about the mech- vartis) is a monoclonal antibody direct- safety issues. “We know that anti-IgE has those medications. anisms of our dermatological diseases,” ed against IgE that is approved for treat- a very good safety profile from the thou- “Anything else that’s second-, third-, or observed Dr. Zuberbier, professor of der- ment of severe allergic asthma. It binds sands of asthma patients treated with fourth-line is not licensed for treatment matology and head of the allergy branch to IgE, preventing it from binding to the this drug,” he said. of urticaria patients, so we’re in desper- at Charité University Hospital. He was IgE receptor on mast cells. Xolair is indicated in the United States ate need of new therapies for patients not involved in Dr. Maurer’s study. For their proof-of-concept study, Dr. for treating adults and adolescents aged 12 who are resistant to nonsedating anti- The study was funded by Genentech Maurer and coworkers restricted eligi- years and older with moderate to severe histamines,” he said. and Novartis. Dr. Maurer has served as bility to patients with one specific sub- persistent asthma. In 2007, the Food and Questions that remain to be answered a consultant to the companies. ■ More Research Needed Ustekinumab Found to Help Improve Lichen Planus from page 1 meet criteria for full-blown skin disease affecting up to 2% Sexual Function in Psoriasis Patients metabolic syndrome, it’s also of the population. The finding likely their cardiovascular that it’s associated with an in- BY BRUCE JANCIN dropped by 9.1 points for ustek- had psoriatic arthritis. event rate will be somewhat creased rate of dyslipidemia, inumab patients, compared with Question 9 on the DLQI is less as well, although this as has previously been estab- B ERLIN — Impaired sexual a 0.5-point dip in the placebo designed to explore sexual prob- wasn’t an end point in the lished to be the case in psoria- function is extremely common arm, according to Dr. Guenther, lems. Here’s the phrasing: lichen planus study, said Dr. sis, raises the question of in the setting of moderate to se- medical director of the Guen- “Over the last week, how much Cohen at the meeting. whether the risk of hyperlipi- vere psoriasis, and ustekinumab ther Dermatology Research has your skin caused any sexu- The case-control study also demia is increased across the therapy reduces these problems Centre and professor of derma- al difficulties?” board in patients by 10-fold. tology at the University of West- The response options are “not ‘We’re all focusing with the other That’s a key quality of life ern Ontario, London. at all,” “a little,” “a lot,” “very a lot of energy chronic inflamma- finding from the ongoing ran- The DLQI is scored on a 0-30 much,” or “not relevant.” A re- and research on tory papulosqua- domized double-blind phase III scale. A 5-point or greater im- ply of “a lot” or “very much” psoriasis. But we mous skin diseases PHOENIX-1 and -2 clinical trials provement is considered clini- was interpreted as indicating should focus on through some of this human monoclonal anti- cally significant. sexual difficulties. other diseases as shared but un- body directed against the proin- The PHOENIX trials include The prevalence of impaired well.’ known mechanism. flammatory cytokines in- 1,996 adults with moderate to sexual function by this measure “I’ve analyzed terkeukin-12 and -23, Dr. Lyn severe psoriasis who were ran- went from 22.4% at baseline— DR. COHEN preliminary data in Guenther reported at the annu- domized 2:1 to ustekinumab 27.1% in women and 20.8% in patients with seb- al congress of the European (Stelara) at 45 mg or 90 mg at men—to 2.7% after 12 weeks on identified an intriguing, pre- orrheic dermatitis or pityriasis Academy of Dermatology and weeks 0, 4, 12, and every 12 ustekinumab. There was no viously undescribed associa- rubra pilaris, and I see the Venereology. weeks thereafter or to placebo. change in the placebo group, tion between lichen planus same association. But this def- The marked reduction in sex- After 12 weeks, patients in the but they showed markedly im- and hypothyroidism. initely requires further re- ual difficulties was paralleled by placebo group were crossed proved overall quality of life and The prevalence of hy- search,” Dr. Cohen said. a sharp improvement in overall over to ustekinumab. sexual function upon repeat pothyroidism was 10% in the “We’re all focusing a lot of quality of life in the ustekinum- The mean age of participants DLQI testing at 24-28 weeks— lichen planus group, com- our energy and research on ab-treated patients in the at entry was 46 years. Sixty- 3 months or more after having pared with 5.7% in controls. [the cardiovascular risk of] PHOENIX studies. Their mean nine percent are men. Their av- been switched to ustekinumab. The explanation for the link is psoriasis. But we should focus baseline score on the Dermatol- erage baseline Psoriasis Area There was no significant differ- as yet unclear, but Dr. Cohen on other diseases as well,” he ogy Life Quality Index (DLQI) and Severity Index (PASI) score ence between patients on 90 mg indicated that he and his added. was 12, reflecting a very large was 20, with 26% of their body as opposed to 45 mg. coworkers are eager to follow Dr. Cohen didn’t report negative impact on quality of surface area being affected and The studies are funded by up on it. having any relevant conflicts life. Twelve weeks into the stud- an average disease duration of Centocor. Dr. Guenther is a con- Lichen planus is a common of interest. ■ ies, the average DLQI had 20 years. Twenty-eight percent sultant to the company. ■