E ach year, you and your colleagues will diagnose more than 150,000 patients with new cases of psoriasis — 20,000 of these patients will be children, according to the American Academy of Dermatology (AAD). For the more than 7 million Americans who suffer from the chronic, often debilitating, condition of psoriasis, a host of drug therapies offers new hope for treatment. At the recent AAD meeting, much research was unveiled about therapeutic advances in the treatment of psoriasis. In the following pages, we’ll report a sampling of studies to give a look at some of the exciting research highlights. Psoriatic Arthritis Drug Promising Results for Treating Psoriasis In a Phase III study of the injectable drug etanercept (Enbrel), which was the first drug approved to treat psoriatic arthritis, the drug showed promise for also treating psoriasis. This TNF-alpha inhibitor, which is given via subcutaneous injection, was studied in 650 patients to determine its effectiveness in treating psoriasis. Alice Gottlieb, M.D., Ph.D., professor of medicine at the University of Medicine and Dentistry at the Robert Wood Johnson Medical School in New Jersey, presented the study results released at this year’s annual AAD meeting in San Francisco. The highlights are as follows: — Patients who received 50 mg of etanercept twice a week. • At 3 months. Of the patients in this group, 49% experienced at least a 75% improvement in their psoriasis, as compared to placebo. • At 6 months. After taking etanercept for this length of time, the number of patients who experienced at least 75% improvement in their psoriasis had increased to 60%. — Patients who received 25 mg of etanercept twice a week. • At 3 months. In this patient group, more than one-third of patients experienced at least a 75% improvement in their psoriasis. • At 6 months. After this time period, almost half of the patients had at least a 75% improvement in their disease. Enbrel’s manufacturers, Amgen and Wyeth, hope to gain approval for the indication of psoriasis treatment some time next year. Research Results on Efalizumab Long-Term Treatment Studied Results from an ongoing, open-label, multicenter trial of efalizumab (Raptiva) designed to test the safety, tolerability and efficacy of this biologic therapy in patients who have moderate to severe plaque psoriasis were presented at this year’s AAD meeting. The findings are based on results from 15 months (60) weeks of continuous treatment with efalizumab. Of the 339 patients who entered the trial, 228 patients were still enrolled by week 60. Here’s a look at the long-term study results for these patients: • At week 60, 80% of the patients maintained a PASI score of 50; 65% maintained a PASI score of 75. • Patients showed no signs of cumulative toxicity, end-organ damage or malignancy from taking the drug for this amount of time. • Researchers concluded that the preliminary findings indicated the rationale for long-term, weekly treatment with efalizumab. Retreatment Study Final Results Revealed In this study, 365 patients were enrolled in the treatment group. Of these, 202 received 1 mg/kg of efalizumab, and 163 patients received a dose of 2 mg/kg of the drug. The drug was administered subcutaneously on a weekly basis. All of the patients who participated in the study had previously participated in a Phase I, II, or III trial of efalizumab. At the end of the 12-week retreatment period, 95% of the patients had completed therapy. Here’s a look at the final study results: • 25% of patients achieved at least 75% PASI improvement and 57% of patients achieved at least 50% PASI improvement. These response rates are comparable to those that patients who were enrolled in Phase III trials of efalizumab experienced. • 27% of patients achieved an overall lesion clearance of “minimal” or “clear” — an improvement from their baseline rankings. • 38% of patients achieved a Physician’s Global Assessment change of “excellent” or “cleared.” • 76% of patients expressed satisfaction with the overall treatment. • Reports of adverse events (the most common being headache, nonspecific infection, pain, chills, rhinitis and cough) were consistent with prior clinical studies. • In this study, the efficacy, safety and tolerability of efalizumab treatment were comparable to an initial course of efalizumab therapy. Researchers concluded that patients’ positive responses regarding satisfaction with the therapy are associated with the convenience of efalizumab’s administration route of once-weekly at-home, subcutaneous injections. National Psoriasis Foundation Materials New Psoriasis Member Support Kit The National Psoriasis Foundation is now offering a new member support kit that will include the following materials: • a bi-monthly magazine — Psoriasis Advance • a guide to more than 300 treatment options titled the “Psoriasis and Psoriatic Arthritis Treatment Guide” • the “Guide to Living with Psoriasis and Psoriatic Arthritis.” If your patients are interested in receiving these materials, they may contact the National Psoriasis Foundation at (800) 723-9166, or visit www.psoriasis.org. The kit is available for a donation of any amount. New Psoriatic Arthritis Treatment? First Biologic Approved for Psoriasis Under Study Alefacept (Amevive), the first biologic treatment FDA approved for psoriasis is going after an indication for psoriatic arthritis. This recombinantly engineered LFA-1/IgG1 human fusion protein, which was approved this past January, was studied in a small group of psoriatic arthritis patients. Eleven patients with plaque psoriasis and moderate to severe psoriatic arthritis underwent treatment with alefacept for 12 weeks and were followed for a total of 16. Patients were assessed at the beginning of treatment, at weeks 4 and 12 and then again 4 weeks after treatment was completed. Results were presented at the AAD. A group of researchers from the Netherlands reported the following: • Alefacept significantly improved tender, swollen joints. Psoriasis symptoms were improved by a mean of 42% (as evaluated by PASI) in seven patients. Three of these patients had lowered PASI scores by 50% or more after their last dose of alefacept. Oral Tazarotene Its Role in Treating Psoriasis Already available as a topical treatment for psoriasis and acne — and recently approved by the FDA for treating certain signs of facial photodamage — tazarotene has already taken on many roles. The oral form of the drug is now in late-stage studies for treating moderate to severe psoriasis. Results presented at this year’s AAD meeting by John Koo, M.D., were based on data from two Phase III trials involving 690 patients who took 4.5 mg of tazarotene qd for 12 weeks. Patients were then followed for 12 additional weeks. Dr. Koo indicated that more than half of the patients taking the drug experienced a 50% improvement in their psoriasis; 30% had improvement of at least 75%. The most common reported adverse effects included, cracked lips, dry skin, headaches, aches and pains. Research results also showed that tazarotene, a vitamin A derivative, cleared from the body within 1 month — an important fact for women who wish to become pregnant and want to avoid birth defects, which have been associated with vitamin A derivatives. Allergan, the drug’s manufacturer, will seek approval for the oral form of tazarotene in mid to late 2003. Research on Infliximab Results from 10 weeks of a Phase II Study Researchers reported on the rapid rate of response achieved with infliximab (Remicade) and other highlights from the first 10 weeks of a Phase II clinical trial with this anti-TNF-alpha monoclonal antibody for patients with plaque-type psoriasis. This multicenter, randomized, double-blind study followed 249 patients with moderate to severe plaque-type psoriasis. Patients randomly received either placebo (51 patients), or 3 mg/kg of infliximab (99 patients) or 5 mg/kg of infliximab (99 patients) at weeks 0, 2 and 6. At week 10 researchers evaluated the results, which were as follows: — Of the group of patients who received the dose of 5 mg/kg: • 88% of patients of patients experienced at least 75% improvement in PASI scores compared with baseline scores. • Nearly half achieved at least a 75% improvement in PASI scores as early as the fourth week. • 58% achieved 90% improvement in PASI by week 10. — Of the group of patients who received the dose of 3 mg/kg: • 72% of patients experienced at least 75% improvement in PASI scores compared with baseline scores. — In both treatment groups: • By week 4, patients in both treatment groups experienced a 75% improvement in PASI scores. • Only 6% of patients treated with placebo experienced clearing. Researchers planned to continue the study for a total 26 weeks. Oral Pimecrolimus Treating Moderate to Severe Plaque-Type Psoriasis Certain doses of oral pimecrolimus (Elidel) were found to be effective in treating plaque-type psoriasis, according to research presented at the AAD. In the 12-week, randomized, double-blind, placebo-controlled, multicenter study, 143 patients were given either placebo (37 patients) or one of three doses of oral pimecrolimus — 10 mg (38 patients), 20 mg (33 patients) or 30 mg (35 patients). Patients received the doses b.i.d. Here’s a look at the highlights from the data: • Patients who received the 20 mg and 30 mg doses experienced significantly greater improvement in their PASI scores at weeks 7 and 13. • The median reduction in PASI at week 7 was 57.6% for the 20-mg dosing group and 67% for the 30-mg dosing group. • At week 13, the scores for these groups were 58.3% for the 20-mg dosing group and 80% for the 30-mg dosing group. Overall, the therapy was well tolerated at all the doses tested. Few adverse events were noted, and there was no evidence of serious organ-specific toxicity.
Wealth of Promising Treatments
E ach year, you and your colleagues will diagnose more than 150,000 patients with new cases of psoriasis — 20,000 of these patients will be children, according to the American Academy of Dermatology (AAD). For the more than 7 million Americans who suffer from the chronic, often debilitating, condition of psoriasis, a host of drug therapies offers new hope for treatment. At the recent AAD meeting, much research was unveiled about therapeutic advances in the treatment of psoriasis. In the following pages, we’ll report a sampling of studies to give a look at some of the exciting research highlights. Psoriatic Arthritis Drug Promising Results for Treating Psoriasis In a Phase III study of the injectable drug etanercept (Enbrel), which was the first drug approved to treat psoriatic arthritis, the drug showed promise for also treating psoriasis. This TNF-alpha inhibitor, which is given via subcutaneous injection, was studied in 650 patients to determine its effectiveness in treating psoriasis. Alice Gottlieb, M.D., Ph.D., professor of medicine at the University of Medicine and Dentistry at the Robert Wood Johnson Medical School in New Jersey, presented the study results released at this year’s annual AAD meeting in San Francisco. The highlights are as follows: — Patients who received 50 mg of etanercept twice a week. • At 3 months. Of the patients in this group, 49% experienced at least a 75% improvement in their psoriasis, as compared to placebo. • At 6 months. After taking etanercept for this length of time, the number of patients who experienced at least 75% improvement in their psoriasis had increased to 60%. — Patients who received 25 mg of etanercept twice a week. • At 3 months. In this patient group, more than one-third of patients experienced at least a 75% improvement in their psoriasis. • At 6 months. After this time period, almost half of the patients had at least a 75% improvement in their disease. Enbrel’s manufacturers, Amgen and Wyeth, hope to gain approval for the indication of psoriasis treatment some time next year. Research Results on Efalizumab Long-Term Treatment Studied Results from an ongoing, open-label, multicenter trial of efalizumab (Raptiva) designed to test the safety, tolerability and efficacy of this biologic therapy in patients who have moderate to severe plaque psoriasis were presented at this year’s AAD meeting. The findings are based on results from 15 months (60) weeks of continuous treatment with efalizumab. Of the 339 patients who entered the trial, 228 patients were still enrolled by week 60. Here’s a look at the long-term study results for these patients: • At week 60, 80% of the patients maintained a PASI score of 50; 65% maintained a PASI score of 75. • Patients showed no signs of cumulative toxicity, end-organ damage or malignancy from taking the drug for this amount of time. • Researchers concluded that the preliminary findings indicated the rationale for long-term, weekly treatment with efalizumab. Retreatment Study Final Results Revealed In this study, 365 patients were enrolled in the treatment group. Of these, 202 received 1 mg/kg of efalizumab, and 163 patients received a dose of 2 mg/kg of the drug. The drug was administered subcutaneously on a weekly basis. All of the patients who participated in the study had previously participated in a Phase I, II, or III trial of efalizumab. At the end of the 12-week retreatment period, 95% of the patients had completed therapy. Here’s a look at the final study results: • 25% of patients achieved at least 75% PASI improvement and 57% of patients achieved at least 50% PASI improvement. These response rates are comparable to those that patients who were enrolled in Phase III trials of efalizumab experienced. • 27% of patients achieved an overall lesion clearance of “minimal” or “clear” — an improvement from their baseline rankings. • 38% of patients achieved a Physician’s Global Assessment change of “excellent” or “cleared.” • 76% of patients expressed satisfaction with the overall treatment. • Reports of adverse events (the most common being headache, nonspecific infection, pain, chills, rhinitis and cough) were consistent with prior clinical studies. • In this study, the efficacy, safety and tolerability of efalizumab treatment were comparable to an initial course of efalizumab therapy. Researchers concluded that patients’ positive responses regarding satisfaction with the therapy are associated with the convenience of efalizumab’s administration route of once-weekly at-home, subcutaneous injections. National Psoriasis Foundation Materials New Psoriasis Member Support Kit The National Psoriasis Foundation is now offering a new member support kit that will include the following materials: • a bi-monthly magazine — Psoriasis Advance • a guide to more than 300 treatment options titled the “Psoriasis and Psoriatic Arthritis Treatment Guide” • the “Guide to Living with Psoriasis and Psoriatic Arthritis.” If your patients are interested in receiving these materials, they may contact the National Psoriasis Foundation at (800) 723-9166, or visit www.psoriasis.org. The kit is available for a donation of any amount. New Psoriatic Arthritis Treatment? First Biologic Approved for Psoriasis Under Study Alefacept (Amevive), the first biologic treatment FDA approved for psoriasis is going after an indication for psoriatic arthritis. This recombinantly engineered LFA-1/IgG1 human fusion protein, which was approved this past January, was studied in a small group of psoriatic arthritis patients. Eleven patients with plaque psoriasis and moderate to severe psoriatic arthritis underwent treatment with alefacept for 12 weeks and were followed for a total of 16. Patients were assessed at the beginning of treatment, at weeks 4 and 12 and then again 4 weeks after treatment was completed. Results were presented at the AAD. A group of researchers from the Netherlands reported the following: • Alefacept significantly improved tender, swollen joints. Psoriasis symptoms were improved by a mean of 42% (as evaluated by PASI) in seven patients. Three of these patients had lowered PASI scores by 50% or more after their last dose of alefacept. Oral Tazarotene Its Role in Treating Psoriasis Already available as a topical treatment for psoriasis and acne — and recently approved by the FDA for treating certain signs of facial photodamage — tazarotene has already taken on many roles. The oral form of the drug is now in late-stage studies for treating moderate to severe psoriasis. Results presented at this year’s AAD meeting by John Koo, M.D., were based on data from two Phase III trials involving 690 patients who took 4.5 mg of tazarotene qd for 12 weeks. Patients were then followed for 12 additional weeks. Dr. Koo indicated that more than half of the patients taking the drug experienced a 50% improvement in their psoriasis; 30% had improvement of at least 75%. The most common reported adverse effects included, cracked lips, dry skin, headaches, aches and pains. Research results also showed that tazarotene, a vitamin A derivative, cleared from the body within 1 month — an important fact for women who wish to become pregnant and want to avoid birth defects, which have been associated with vitamin A derivatives. Allergan, the drug’s manufacturer, will seek approval for the oral form of tazarotene in mid to late 2003. Research on Infliximab Results from 10 weeks of a Phase II Study Researchers reported on the rapid rate of response achieved with infliximab (Remicade) and other highlights from the first 10 weeks of a Phase II clinical trial with this anti-TNF-alpha monoclonal antibody for patients with plaque-type psoriasis. This multicenter, randomized, double-blind study followed 249 patients with moderate to severe plaque-type psoriasis. Patients randomly received either placebo (51 patients), or 3 mg/kg of infliximab (99 patients) or 5 mg/kg of infliximab (99 patients) at weeks 0, 2 and 6. At week 10 researchers evaluated the results, which were as follows: — Of the group of patients who received the dose of 5 mg/kg: • 88% of patients of patients experienced at least 75% improvement in PASI scores compared with baseline scores. • Nearly half achieved at least a 75% improvement in PASI scores as early as the fourth week. • 58% achieved 90% improvement in PASI by week 10. — Of the group of patients who received the dose of 3 mg/kg: • 72% of patients experienced at least 75% improvement in PASI scores compared with baseline scores. — In both treatment groups: • By week 4, patients in both treatment groups experienced a 75% improvement in PASI scores. • Only 6% of patients treated with placebo experienced clearing. Researchers planned to continue the study for a total 26 weeks. Oral Pimecrolimus Treating Moderate to Severe Plaque-Type Psoriasis Certain doses of oral pimecrolimus (Elidel) were found to be effective in treating plaque-type psoriasis, according to research presented at the AAD. In the 12-week, randomized, double-blind, placebo-controlled, multicenter study, 143 patients were given either placebo (37 patients) or one of three doses of oral pimecrolimus — 10 mg (38 patients), 20 mg (33 patients) or 30 mg (35 patients). Patients received the doses b.i.d. Here’s a look at the highlights from the data: • Patients who received the 20 mg and 30 mg doses experienced significantly greater improvement in their PASI scores at weeks 7 and 13. • The median reduction in PASI at week 7 was 57.6% for the 20-mg dosing group and 67% for the 30-mg dosing group. • At week 13, the scores for these groups were 58.3% for the 20-mg dosing group and 80% for the 30-mg dosing group. Overall, the therapy was well tolerated at all the doses tested. Few adverse events were noted, and there was no evidence of serious organ-specific toxicity.
E ach year, you and your colleagues will diagnose more than 150,000 patients with new cases of psoriasis — 20,000 of these patients will be children, according to the American Academy of Dermatology (AAD). For the more than 7 million Americans who suffer from the chronic, often debilitating, condition of psoriasis, a host of drug therapies offers new hope for treatment. At the recent AAD meeting, much research was unveiled about therapeutic advances in the treatment of psoriasis. In the following pages, we’ll report a sampling of studies to give a look at some of the exciting research highlights. Psoriatic Arthritis Drug Promising Results for Treating Psoriasis In a Phase III study of the injectable drug etanercept (Enbrel), which was the first drug approved to treat psoriatic arthritis, the drug showed promise for also treating psoriasis. This TNF-alpha inhibitor, which is given via subcutaneous injection, was studied in 650 patients to determine its effectiveness in treating psoriasis. Alice Gottlieb, M.D., Ph.D., professor of medicine at the University of Medicine and Dentistry at the Robert Wood Johnson Medical School in New Jersey, presented the study results released at this year’s annual AAD meeting in San Francisco. The highlights are as follows: — Patients who received 50 mg of etanercept twice a week. • At 3 months. Of the patients in this group, 49% experienced at least a 75% improvement in their psoriasis, as compared to placebo. • At 6 months. After taking etanercept for this length of time, the number of patients who experienced at least 75% improvement in their psoriasis had increased to 60%. — Patients who received 25 mg of etanercept twice a week. • At 3 months. In this patient group, more than one-third of patients experienced at least a 75% improvement in their psoriasis. • At 6 months. After this time period, almost half of the patients had at least a 75% improvement in their disease. Enbrel’s manufacturers, Amgen and Wyeth, hope to gain approval for the indication of psoriasis treatment some time next year. Research Results on Efalizumab Long-Term Treatment Studied Results from an ongoing, open-label, multicenter trial of efalizumab (Raptiva) designed to test the safety, tolerability and efficacy of this biologic therapy in patients who have moderate to severe plaque psoriasis were presented at this year’s AAD meeting. The findings are based on results from 15 months (60) weeks of continuous treatment with efalizumab. Of the 339 patients who entered the trial, 228 patients were still enrolled by week 60. Here’s a look at the long-term study results for these patients: • At week 60, 80% of the patients maintained a PASI score of 50; 65% maintained a PASI score of 75. • Patients showed no signs of cumulative toxicity, end-organ damage or malignancy from taking the drug for this amount of time. • Researchers concluded that the preliminary findings indicated the rationale for long-term, weekly treatment with efalizumab. Retreatment Study Final Results Revealed In this study, 365 patients were enrolled in the treatment group. Of these, 202 received 1 mg/kg of efalizumab, and 163 patients received a dose of 2 mg/kg of the drug. The drug was administered subcutaneously on a weekly basis. All of the patients who participated in the study had previously participated in a Phase I, II, or III trial of efalizumab. At the end of the 12-week retreatment period, 95% of the patients had completed therapy. Here’s a look at the final study results: • 25% of patients achieved at least 75% PASI improvement and 57% of patients achieved at least 50% PASI improvement. These response rates are comparable to those that patients who were enrolled in Phase III trials of efalizumab experienced. • 27% of patients achieved an overall lesion clearance of “minimal” or “clear” — an improvement from their baseline rankings. • 38% of patients achieved a Physician’s Global Assessment change of “excellent” or “cleared.” • 76% of patients expressed satisfaction with the overall treatment. • Reports of adverse events (the most common being headache, nonspecific infection, pain, chills, rhinitis and cough) were consistent with prior clinical studies. • In this study, the efficacy, safety and tolerability of efalizumab treatment were comparable to an initial course of efalizumab therapy. Researchers concluded that patients’ positive responses regarding satisfaction with the therapy are associated with the convenience of efalizumab’s administration route of once-weekly at-home, subcutaneous injections. National Psoriasis Foundation Materials New Psoriasis Member Support Kit The National Psoriasis Foundation is now offering a new member support kit that will include the following materials: • a bi-monthly magazine — Psoriasis Advance • a guide to more than 300 treatment options titled the “Psoriasis and Psoriatic Arthritis Treatment Guide” • the “Guide to Living with Psoriasis and Psoriatic Arthritis.” If your patients are interested in receiving these materials, they may contact the National Psoriasis Foundation at (800) 723-9166, or visit www.psoriasis.org. The kit is available for a donation of any amount. New Psoriatic Arthritis Treatment? First Biologic Approved for Psoriasis Under Study Alefacept (Amevive), the first biologic treatment FDA approved for psoriasis is going after an indication for psoriatic arthritis. This recombinantly engineered LFA-1/IgG1 human fusion protein, which was approved this past January, was studied in a small group of psoriatic arthritis patients. Eleven patients with plaque psoriasis and moderate to severe psoriatic arthritis underwent treatment with alefacept for 12 weeks and were followed for a total of 16. Patients were assessed at the beginning of treatment, at weeks 4 and 12 and then again 4 weeks after treatment was completed. Results were presented at the AAD. A group of researchers from the Netherlands reported the following: • Alefacept significantly improved tender, swollen joints. Psoriasis symptoms were improved by a mean of 42% (as evaluated by PASI) in seven patients. Three of these patients had lowered PASI scores by 50% or more after their last dose of alefacept. Oral Tazarotene Its Role in Treating Psoriasis Already available as a topical treatment for psoriasis and acne — and recently approved by the FDA for treating certain signs of facial photodamage — tazarotene has already taken on many roles. The oral form of the drug is now in late-stage studies for treating moderate to severe psoriasis. Results presented at this year’s AAD meeting by John Koo, M.D., were based on data from two Phase III trials involving 690 patients who took 4.5 mg of tazarotene qd for 12 weeks. Patients were then followed for 12 additional weeks. Dr. Koo indicated that more than half of the patients taking the drug experienced a 50% improvement in their psoriasis; 30% had improvement of at least 75%. The most common reported adverse effects included, cracked lips, dry skin, headaches, aches and pains. Research results also showed that tazarotene, a vitamin A derivative, cleared from the body within 1 month — an important fact for women who wish to become pregnant and want to avoid birth defects, which have been associated with vitamin A derivatives. Allergan, the drug’s manufacturer, will seek approval for the oral form of tazarotene in mid to late 2003. Research on Infliximab Results from 10 weeks of a Phase II Study Researchers reported on the rapid rate of response achieved with infliximab (Remicade) and other highlights from the first 10 weeks of a Phase II clinical trial with this anti-TNF-alpha monoclonal antibody for patients with plaque-type psoriasis. This multicenter, randomized, double-blind study followed 249 patients with moderate to severe plaque-type psoriasis. Patients randomly received either placebo (51 patients), or 3 mg/kg of infliximab (99 patients) or 5 mg/kg of infliximab (99 patients) at weeks 0, 2 and 6. At week 10 researchers evaluated the results, which were as follows: — Of the group of patients who received the dose of 5 mg/kg: • 88% of patients of patients experienced at least 75% improvement in PASI scores compared with baseline scores. • Nearly half achieved at least a 75% improvement in PASI scores as early as the fourth week. • 58% achieved 90% improvement in PASI by week 10. — Of the group of patients who received the dose of 3 mg/kg: • 72% of patients experienced at least 75% improvement in PASI scores compared with baseline scores. — In both treatment groups: • By week 4, patients in both treatment groups experienced a 75% improvement in PASI scores. • Only 6% of patients treated with placebo experienced clearing. Researchers planned to continue the study for a total 26 weeks. Oral Pimecrolimus Treating Moderate to Severe Plaque-Type Psoriasis Certain doses of oral pimecrolimus (Elidel) were found to be effective in treating plaque-type psoriasis, according to research presented at the AAD. In the 12-week, randomized, double-blind, placebo-controlled, multicenter study, 143 patients were given either placebo (37 patients) or one of three doses of oral pimecrolimus — 10 mg (38 patients), 20 mg (33 patients) or 30 mg (35 patients). Patients received the doses b.i.d. Here’s a look at the highlights from the data: • Patients who received the 20 mg and 30 mg doses experienced significantly greater improvement in their PASI scores at weeks 7 and 13. • The median reduction in PASI at week 7 was 57.6% for the 20-mg dosing group and 67% for the 30-mg dosing group. • At week 13, the scores for these groups were 58.3% for the 20-mg dosing group and 80% for the 30-mg dosing group. Overall, the therapy was well tolerated at all the doses tested. Few adverse events were noted, and there was no evidence of serious organ-specific toxicity.
