To the Editor: We appreciate the comments of Dr Roenigk, Dr Auerbach, and Dr Maibach1Roenigk Jr., H.H. Auerbach R. Maibach H.I. Methotrexate guidelines 2009?.J Am Acad Dermatol. 2010; 63: 344-345Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar regarding our article, “Methotrexate and Psoriasis: 2009 National Psoriasis Foundation Consensus Conference.”2Kalb R.E. Strober B. Weinstein G. Lebwohl M. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference.J Am Acad Dermatol. 2009; 60: 824-837Abstract Full Text Full Text PDF PubMed Scopus (261) Google Scholar We would like to acknowledge the work of these physicians who pioneered the use of methotrexate and developed the initial guidelines for its use. Their work was acknowledged with praise in our methotrexate article. We would like to apologize for not having consulted them directly. We welcome this opportunity to respond to their comments. The last methotrexate guidelines were a consensus statement of a small group of recognized experts, including two of the authors of the current guidelines (G. W. and M. L.). It was neither approved by the American Academy of Dermatology (AAD) nor reviewed by the AAD Board before its publication. The more recent psoriasis expert work group of the AAD guidelines did not deal exclusively with methotrexate. The brief portion of these guidelines concerning methotrexate was written by one of the authors of our methotrexate article (M. L.), and many of the recommendations (Tables I-VI) were used with permission from our article.3Menter A. Korman N.J. Elmets C.A. Feldman S.R. Gelfand J.M. Gordon K.B. et al.Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents.J Am Acad Dermatol. 2009; 61: 451-485Abstract Full Text Full Text PDF PubMed Scopus (446) Google Scholar We disagree that the article is largely unchanged from the 1998 methotrexate guidelines. Besides the change in liver biopsy guidelines new information was presented regarding the use of methotrexate in psoriasis, the role of folic acid supplementation, the importance of hematologic toxicity and the fact that this toxicity may be more clinically relevant than hepatotoxicity, and the significance of hepatic risk factors in the development of liver toxicity. Importantly, most of the newer information presented was primarily in patients with psoriasis and psoriatic arthritis. It is admittedly difficult to put together a large group of experts without any conflicts of interest. The conflicts of interest must be declared, as they were in our article. As for conflicts of interest affecting content, our article, in fact, eased the biopsy criteria for patients receiving methotrexate, a drug that has been generic for many years. Therefore, our recommendations only have made it a drug that is easier to prescribe. None of the authors of our article or members of the National Psoriasis Foundation medical board have conflicts of interest with the manufacturers of methotrexate, a drug that directly competes with the biologic agents. Finally, we are pleased that Roenigk et al agree with a more liberal approach to liver biopsy in methotrexate-treated patients. The reduction in frequency of liver biopsies is a trend that Roenigk and colleagues started and continued since the first guidelines were published by them nearly 4 decades ago. Methotrexate guidelines 2009?Journal of the American Academy of DermatologyVol. 63Issue 2PreviewTo the Editor: The article by Kalb et al1 in the May 2009 issue of the Journal was prepared as an update of previous methotrexate guidelines.2-5 Three of the original four authors (H.R., H.M., and R.A.) of previous methotrexate guidelines were not consulted in the 2009 update. Why have the guidelines changed from a function of the American Academy of Dermatology (AAD) to the National Psoriasis Foundation (NSF)? A recent member alert (June 22, 2009) from the AAD, requested “member review and comment on the fourth section of newly developed evidenced based Guidelines of Care for the Management and Treatment of Psoriasis.” The Psoriasis Expert Work Group of AAD includes some of the authors of the NSF Methotrexate and Psoriasis 2009 publication. Full-Text PDF Response to the letter to editor re: “Methotrexate and psoriasis: Consensus conference”Journal of the American Academy of DermatologyVol. 66Issue 4PreviewTo the Editor: I read with interest the recent letter to the editor by Kalb et al,1 responding to an earlier letter by Roenigk et al2 on “Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference.”3 Full-Text PDF
Background Biologics are widely used in the treatment of psoriasis and psoriatic arthritis. Objective Our aim was to arrive at a consensus on the kind of monitoring and the vaccinations that should be performed before and during biologic therapy. Methods Medical literature and data presented at meetings were reviewed and a consensus conference was held by members of the Medical Board of the National Psoriasis Foundation. Results Consensus was established on monitoring and vaccination practices that included discussion and recognition of variations in those practices. History, physical examination, chemistry screen with liver function tests, complete blood cell count, and platelet count and tuberculosis testing are widely obtained at baseline and with variable frequencies thereafter. Patients treated with efalizumab have platelet counts checked more often; liver function tests are repeated more frequently in patients treated with infliximab; patients taking tumor necrosis factor blockers undergo tuberculosis testing more often; and patients treated with alefacept have CD4 counts checked approximately every 2 weeks. Avoidance of live vaccines during biologic therapy and administration of essential vaccines before biologic therapy were discussed, although vaccination is performed only to a variable degree. There was no consistency in the measurement of antinuclear antibodies among the experts. Limitations There are few evidence-based studies on monitoring practices for patients with psoriasis taking biologic therapies. Conclusions In patients taking biologic therapies for psoriasis, monitoring of blood chemistries, blood counts, CD4 counts, antinuclear antibodies, tuberculin skin tests, history, and physical examination may be warranted depending on the particular therapy and the particular patient. Vaccination practices are also addressed.
Background: Previous studies of infliximab) in psoriasis have demonstrated rapid improvement with induction therapy and sustained response with regularly administered maintenance therapy.Objective: The efficacy and safety of continuous (every-8-week) and intermittent (as-needed) maintenance regimens were compared.Methods: Patients with moderate-to-severe psoriasis (n = 835) were randomized to induction therapy (weeks 0, 2, and 6) with infliximab 3 mg/kg or 5 mg/kg or placebo. Infliximab-treated patients were randomized again at week 14 to continuous or intermittent maintenance regimens at their induction close.Results: At week 10, 75.5% and 70.3% of patients in the infliximab 5 mg/kg and 3 mg/kg groups, respectively, achieved PASI 75; 45.2% and 37.1% achieved PASI 90 (vs 1.9% [PASI 75] and 0.5% [PASI 901 for placebo; P <.001). Through week 50, PASI responses were better maintained with continuous compared with intermittent therapy within each close, and with 5 mg/kg compared with 3 mg/kg continuous therapy.Limitations: Longer term (>1 year) maintenance therapy and further study Of infliximab serum concentrations over this period, in both PASI 75 responders and non-responders, would he preferable.Conclusions: Through week 50, response was hest maintained with continuous infliximab therapy. Infliximab was generally well-tolerated in most patients.
Many patients with rosacea are unable to tolerate extended treatment periods with topical agents because of the unusually high skin sensitivity that often accompanies rosacea. Kinetin (N-6-furfuryladenine) is a plant cytokinin that reportedly helps restore skin barrier function and may be useful to ameliorate the signs and symptoms of rosacea. The purpose of this open-label study was to determine the tolerance and efficacy of twice-daily application of kinetin 0.1% lotion for improving the signs and symptoms of mild to moderate facial rosacea. Subjects applied kinetin 0.1% lotion twice daily to the face, with daily use of a sunscreen of sun protection factor 30. Subjects were evaluated at baseline and at 4-week intervals for 12 weeks to assess efficacy and tolerance. Results of this study suggest that kinetin 0.1% lotion is a well-tolerated moisturizing lotion option for subjects with mild to moderate inflammatory rosacea.
Journal of the European Academy of Dermatology and VenereologyVolume 20, Issue 10 p. 1337-1338 Dermographism secondary to trauma from a coral reef JJ Wu, Corresponding Author JJ Wu Department of Dermatology, University of California, Irvine, Irvine, CA, USA, * Corresponding author, C340, Medical Science I, University of California, Irvine, Irvine, CA 92697-2400, tel. (949) 824-7103; fax (949) 824-8954; E-mail: [email protected]Search for more papers by this authorDB Huang, DB Huang Division of Infectious Diseases, Department of Medicine and University of Texas at Houston School of Public Health, University of Texas Health Science Center at Houston, TX, USA.Search for more papers by this authorJE Murase, JE Murase Department of Dermatology, University of California, Irvine, Irvine, CA, USA,Search for more papers by this authorGD Weinstein, GD Weinstein Department of Dermatology, University of California, Irvine, Irvine, CA, USA,Search for more papers by this author JJ Wu, Corresponding Author JJ Wu Department of Dermatology, University of California, Irvine, Irvine, CA, USA, * Corresponding author, C340, Medical Science I, University of California, Irvine, Irvine, CA 92697-2400, tel. (949) 824-7103; fax (949) 824-8954; E-mail: [email protected]Search for more papers by this authorDB Huang, DB Huang Division of Infectious Diseases, Department of Medicine and University of Texas at Houston School of Public Health, University of Texas Health Science Center at Houston, TX, USA.Search for more papers by this authorJE Murase, JE Murase Department of Dermatology, University of California, Irvine, Irvine, CA, USA,Search for more papers by this authorGD Weinstein, GD Weinstein Department of Dermatology, University of California, Irvine, Irvine, CA, USA,Search for more papers by this author First published: 16 October 2006 https://doi.org/10.1111/j.1468-3083.2006.01683.xCitations: 3Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article.Citing Literature Volume20, Issue10November 2006Pages 1337-1338 RelatedInformation
To the Editor: We read with interest the article by Hall and Phillips1Hall G. Phillips T.J. Estrogen and skin: the effects of estrogen, menopause, and hormone replacement therapy on the skin.J Am Acad Dermatol. 2005; 53: 555-568Abstract Full Text Full Text PDF PubMed Scopus (218) Google Scholar entitled “Estrogen and skin: The effects of estrogen, menopause, and hormone replacement therapy on the skin.” We would like to comment on the possible therapeutic benefit of estrogen for cutaneous autoimmune disease, and the discussion of risks involved with hormone replacement therapy (HRT) cited in this article.In a discussion of the effect of estrogens and the skin, it is important to comment on the potential immunologic effects of estrogen in autoimmune disease. In pregnancy, estrogen is thought to be responsible for the shift from Th1 to Th2 immunity that promotes fetal survival by decreasing Th1 responses involved in rejection of the fetus as an allograft. As predicted from this immune deviation, autoimmune diseases categorized as Th1 mediated (eg, psoriasis, rheumatoid arthritis, and multiple sclerosis) have been shown to improve in pregnancy. In our study of 74 patients examining the hormonal effects of psoriasis and pregnancy, we found that psoriatic body surface area decreased significantly from 10 to 20 weeks gestation (P = .001) compared with control subjects. There were significant or near significant correlations between improvement in body surface area and estradiol (P = .009, r = 0.648), estriol (P = .063, r = 0.491), and the ratio of estrogen to progesterone (P = .006, r = 0.671). Thus, high levels of estrogen correlated with improvement in psoriasis.2Murase J.E. Chan K.K. Garite T.J. Cooper D.M. Weinstein G.D. Hormonal effect on psoriasis in pregnancy and post partum.Arch Dermatol. 2005; 141: 601-606Crossref PubMed Scopus (125) Google Scholar We believe that estrogen may have the potential to be used as a treatment modality in psoriasis and other cutaneous autoimmune diseases.Secondly, we feel that the authors did not accurately represent Premarin and other estrogen-based HRT formulations in the statement, “There is increased risk of breast cancer…in HRT users” and in Table IV where breast cancer is listed as a “potential risk” of HRT.1Hall G. Phillips T.J. Estrogen and skin: the effects of estrogen, menopause, and hormone replacement therapy on the skin.J Am Acad Dermatol. 2005; 53: 555-568Abstract Full Text Full Text PDF PubMed Scopus (218) Google ScholarThe authors cited data from the preliminary findings of the Women's Health Initiative trial published in the Journal of the American Medical Association in 2002,3Rossouw J.E. Anderson G.L. Prentice R.L. LaCroix A.Z. Kooperberg C. Stefanick M.L. et al.Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the women's health initiative randomized controlled trial.JAMA. 2002; 288: 321-333Crossref PubMed Scopus (13852) Google Scholar aspects of which were contradicted in the final analysis published in the Journal of the American Medical Association in 2004.4Anderson G.L. Limacher M. Assaf A.R. Bassford T. Beresford S.A. Black H. et al.Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the women's health initiative randomized controlled trial.JAMA. 2004; 291: 1701-1712Crossref PubMed Scopus (4105) Google Scholar The first arm of the trial involving Premarin (estrogen only) and Provera (estrogen and progestin) was stopped after 5.2 years because there was an excess number of adverse events (1 in 100 women) when comparing active drug to placebo (7 more coronary heart disease events, 8 more invasive breast cancers, 8 more strokes, and 9 more pulmonary emboli vs 6 fewer colorectal cancers and 5 fewer hip fractures).3Rossouw J.E. Anderson G.L. Prentice R.L. LaCroix A.Z. Kooperberg C. Stefanick M.L. et al.Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the women's health initiative randomized controlled trial.JAMA. 2002; 288: 321-333Crossref PubMed Scopus (13852) Google Scholar The second arm of the trial involving Premarin only was stopped after 6.8 years because it was determined through statistical analysis that an improvement in the primary outcome measure (heart disease) would not be observed (no effect either good or bad). There was an increased risk for stroke and decreased risk for hip fracture. Most importantly, there was a trend for reduction in breast cancer risk.4Anderson G.L. Limacher M. Assaf A.R. Bassford T. Beresford S.A. Black H. et al.Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the women's health initiative randomized controlled trial.JAMA. 2004; 291: 1701-1712Crossref PubMed Scopus (4105) Google Scholar To the Editor: We read with interest the article by Hall and Phillips1Hall G. Phillips T.J. Estrogen and skin: the effects of estrogen, menopause, and hormone replacement therapy on the skin.J Am Acad Dermatol. 2005; 53: 555-568Abstract Full Text Full Text PDF PubMed Scopus (218) Google Scholar entitled “Estrogen and skin: The effects of estrogen, menopause, and hormone replacement therapy on the skin.” We would like to comment on the possible therapeutic benefit of estrogen for cutaneous autoimmune disease, and the discussion of risks involved with hormone replacement therapy (HRT) cited in this article. In a discussion of the effect of estrogens and the skin, it is important to comment on the potential immunologic effects of estrogen in autoimmune disease. In pregnancy, estrogen is thought to be responsible for the shift from Th1 to Th2 immunity that promotes fetal survival by decreasing Th1 responses involved in rejection of the fetus as an allograft. As predicted from this immune deviation, autoimmune diseases categorized as Th1 mediated (eg, psoriasis, rheumatoid arthritis, and multiple sclerosis) have been shown to improve in pregnancy. In our study of 74 patients examining the hormonal effects of psoriasis and pregnancy, we found that psoriatic body surface area decreased significantly from 10 to 20 weeks gestation (P = .001) compared with control subjects. There were significant or near significant correlations between improvement in body surface area and estradiol (P = .009, r = 0.648), estriol (P = .063, r = 0.491), and the ratio of estrogen to progesterone (P = .006, r = 0.671). Thus, high levels of estrogen correlated with improvement in psoriasis.2Murase J.E. Chan K.K. Garite T.J. Cooper D.M. Weinstein G.D. Hormonal effect on psoriasis in pregnancy and post partum.Arch Dermatol. 2005; 141: 601-606Crossref PubMed Scopus (125) Google Scholar We believe that estrogen may have the potential to be used as a treatment modality in psoriasis and other cutaneous autoimmune diseases. Secondly, we feel that the authors did not accurately represent Premarin and other estrogen-based HRT formulations in the statement, “There is increased risk of breast cancer…in HRT users” and in Table IV where breast cancer is listed as a “potential risk” of HRT.1Hall G. Phillips T.J. Estrogen and skin: the effects of estrogen, menopause, and hormone replacement therapy on the skin.J Am Acad Dermatol. 2005; 53: 555-568Abstract Full Text Full Text PDF PubMed Scopus (218) Google Scholar The authors cited data from the preliminary findings of the Women's Health Initiative trial published in the Journal of the American Medical Association in 2002,3Rossouw J.E. Anderson G.L. Prentice R.L. LaCroix A.Z. Kooperberg C. Stefanick M.L. et al.Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the women's health initiative randomized controlled trial.JAMA. 2002; 288: 321-333Crossref PubMed Scopus (13852) Google Scholar aspects of which were contradicted in the final analysis published in the Journal of the American Medical Association in 2004.4Anderson G.L. Limacher M. Assaf A.R. Bassford T. Beresford S.A. Black H. et al.Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the women's health initiative randomized controlled trial.JAMA. 2004; 291: 1701-1712Crossref PubMed Scopus (4105) Google Scholar The first arm of the trial involving Premarin (estrogen only) and Provera (estrogen and progestin) was stopped after 5.2 years because there was an excess number of adverse events (1 in 100 women) when comparing active drug to placebo (7 more coronary heart disease events, 8 more invasive breast cancers, 8 more strokes, and 9 more pulmonary emboli vs 6 fewer colorectal cancers and 5 fewer hip fractures).3Rossouw J.E. Anderson G.L. Prentice R.L. LaCroix A.Z. Kooperberg C. Stefanick M.L. et al.Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the women's health initiative randomized controlled trial.JAMA. 2002; 288: 321-333Crossref PubMed Scopus (13852) Google Scholar The second arm of the trial involving Premarin only was stopped after 6.8 years because it was determined through statistical analysis that an improvement in the primary outcome measure (heart disease) would not be observed (no effect either good or bad). There was an increased risk for stroke and decreased risk for hip fracture. Most importantly, there was a trend for reduction in breast cancer risk.4Anderson G.L. Limacher M. Assaf A.R. Bassford T. Beresford S.A. Black H. et al.Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the women's health initiative randomized controlled trial.JAMA. 2004; 291: 1701-1712Crossref PubMed Scopus (4105) Google Scholar
Objectives: Retinoic acid (RA) and benzoyl peroxide (BP) were studied, comparing their keratolytic efficacy and water barrier disruption to that of salicylic acid (SA), a well-established keratolytic, under similar conditions. Patients/Methods:Six volunteers were included in this blinded study. Eleven randomized test sites were marked on the volar forearms, containing sites for untreated skin at time zero, unoccluded, occlusion, and vehicle controls for 3 and 6 h, and each of BP, RA, and SA solutions for 3 and 6 h. At each time point, occlusion at 5 of the test sites was removed, and chromameter measurements were performed over 30 min. Each site then underwent 25 stratum corneum (SC) tape strippings. At 1, 5, and 30 min after the last stripping at each site, TEWL measurements were performed. Quantitative protein analysis of the SC from the tapes was then performed. Results and Conclusion: After 3 h, BP was significantly more effective in disrupting SC cohesion than SA and RA, indicating BP is a moderate keratolytic agent in addition to its antimicrobial properties. After 6 h, all three agents were similarly effective in keratolysis. Barrier disruption, as measured by TEWL, paralleled depth of SC removal. SA tended to exhibit the greatest keratolytic efficacy superficially, hence its clinical effectiveness in superficial conditions such as comedonal acne, whereas BP was more effective at deeper levels, complimenting its antimicrobial effects and enabling it to treat deeper, more inflammatory lesions. None of the agents significantly affected skin erythema. These techniques provide a robust and rapid assay for in vivo keratolytic demonstration.
Objectives: To investigate prospectively how psoriasis fluctuates in pregnancy and post partum and to correlate hormone levels in pregnancy (progesterone and estrogens) with psoriatic change.Design: Psoriatic body surface area (BSA) in pregnant patients with psoriasis (study group) and nonpregnant, menstruating patients with psoriasis (control group) were assessed 5 times over a year. Hormone levels (progesterone and,estrogens) were measured in the study group and correlated with change in BSA.Setting: University-affiliated obstetric and dermatology clinics.Patients: Forty-seven pregnant patients in the psoriasis group and 27 nonpregnant, menstruating patients in the control group.Results: During pregnancy, 55% of the patients re-ported improvement, 21% reported no change, and 23% reported worsening. However, post partum, only 9% of patients reported improvement, 26% reported no change, and 65% reported worsening. Psoriatic BSA decreased significantly from 10 to 20 weeks'gestation (P < .001) compared with controls, whereas BSA increased significantly by 6 weeks post partum (P = .001) compared with controls. In patients with 10% or greater psoriatic BSA who reported improvement (n = 16; mean BSA, 40%), lesions decreased by 83.8% during pregnancy. There were significant or near significant correlations between improvement in BSA and estradiol (P =. 009, r = 0.648), estriol (P = .06, r = 0.491), and the ratio of estrogen to progesterone (P = .006, r = 0.671).Conclusion: High levels of estrogen correlated with improvement in psoriasis, whereas progesterone levels did not correlate with psoriatic change.
BACKGROUND:Tazarotene in a gel formulation is widely used in the treatment of psoriasis.OBJECTIVE:To determine the efficacy and safety of tazarotene 0.1% and 0.05% creams in the treatment of psoriasis.METHODS:A total of 1303 patients participated in 2 clinical trials. Patients applied tazarotene creams 0.1% and 0.05% or vehicle once daily to all psoriatic lesions for 12 weeks followed by a 12-week posttreatment period.RESULTS:Both creams were significantly more effective than vehicle on the basis of an overall assessment of psoriasis, a global response to treatment, and reduction in plaque elevation and scaling. Therapeutic effect was maintained during the posttreatment period. Common adverse events included signs and symptoms of skin irritation.CONCLUSION:Tazarotene creams were associated with significant reductions in the severity of the clinical signs of psoriasis and were found to be safe with acceptable tolerability. Tazarotene cream 0.1% was generally more effective, although slightly less well tolerated, than the 0.05% cream.
OBJECTIVE:To determine safety and efficacy of monotherapy with etanercept.DESIGN:Randomized, double-blind, placebo-controlled, multicenter study.SETTING:Outpatient, ambulatory; private practice and university dermatology research centers.PATIENTS:Patients aged at least 18 years, with plaque psoriasis involving 10% or more of body surface area; 148 were screened and 112 were randomly assigned to treatment groups and received study drug.INTERVENTIONS:Patients received placebo or etanercept, 25 mg, subcutaneously twice a week for 24 weeks. Other psoriasis therapies were limited during the study.MAIN OUTCOME MEASURES:Safety measurements included tracking of adverse events and laboratory values. Efficacy was evaluated using the Psoriasis Area and Severity Index (PASI); the primary end point was a 75% improvement in PASI. Other efficacy measurements included patient and physician global assessments and quality-of-life measures.RESULTS:After 12 weeks of treatment, 17 (30%) of the 57 etanercept-treated patients and 1 (2%) of the 55 placebo-treated patients had achieved PASI 75%, and after 24 weeks, 32 (56%) of etanercept-treated patients and 3 (5%) of placebo-treated patients had reached this level (P<.001 for both time points). By 24 weeks, psoriasis was clear or minimal by physician's global assessment in more than 50% of patients who received etanercept. Treatment failure (PASI response <50) occurred in 23% of patients at week 24. All other measures confirmed the efficacy of etanercept. Adverse events were similar among etanercept and placebo groups.CONCLUSION:Etanercept monotherapy provided significant benefit to patients with psoriasis and had a favorable safety profile.
Background: Inflammatory cytokines such as tumor necrosis factor (TNF) have been implicated in the pathogenesis of psoriasis. We evaluated the safety and efficacy of etanercept, a TNF antagonist, for the treatment of plaque psoriasis.Methods: In this 24-week, double-blind study, 672 patients underwent randomization and 652 either received placebo or received etanercept subcutaneously at a low dose (25 mg once weekly), a medium dose (25 mg twice weekly), or a high dose (50 mg twice weekly). After 12 weeks, patients in the placebo group began twice-weekly treatment with 25 mg of etanercept. The primary measure of clinical response was the psoriasis area-and-severity index.Results: At week 12, there was an improvement from base line of 75 percent or more in the psoriasis area-and-severity index in 4 percent of the patients in the placebo group, as compared with 14 percent of those in the low-dose-etanercept group, 34 percent in the medium-dose-etanercept group, and 49 percent in the high-dose-etanercept group (P<0.001 for all three comparisons with the placebo group). The clinical responses continued to improve with longer treatment. At week 24, there was at least a 75 percent improvement in the psoriasis area-and-severity index in 25 percent of the patients in the low-dose group, 44 percent of those in the medium-dose group, and 59 percent in the high-dose group. The responses as measured by improvements in the psoriasis area-and-severity index were paralleled by improvements in global assessments by physicians and the patients and in quality-of-life measures. Etanercept was generally well tolerated.Conclusions: The treatment of psoriasis with etanercept led to a significant reduction in the severity of disease over a period of 24 weeks.
P soriasis is a chronic immune-mediated disease that frustrates patients and, all too often, the dermatologists who treat them. New treatments offer the promise of change. Advances in the understanding of the immune basis of psoriasis have led to the development of therapies targeted at immune/inflammatory pathways leading to psoriasis that are safer and more effective. As dermatologists who have seen the results of these drugs firsthand in clinical trials, we see our specialty at the cusp of a revolution, a revolution that will bring new opportunities and benefits to our patients. These new agents will usher in a whole new era of systemic medications for patients suffering from psoriasis.
OBJECTIVE To assess the safety and efficacy of 4 concentrations of tazarotene cream in the treatment of facial photodamage. DESIGN Prospective weekly multicenter, investigator-masked, randomized, parallel-group study. SETTING University hospitals and clinical research centers. PATIENTS Three hundred forty-nine subjects with facial photodamage. INTERVENTION Daily topical application of tazarotene cream (0.01%, 0.025%, 0.05%, and 0.1%) compared with its vehicle and with 0.05% tretinoin emollient cream. RESULTS Tazarotene cream and tretinoin cream significantly improved mottled hyperpigmentation and fine wrinkles. At week 24, treatment success rates based on global responses were 67% (39 of 58 subjects) with 0.1% tazarotene, 52% (30 of 58 subjects) with 0.05% tazarotene, 36% (21 of 58 subjects) with 0.025% tazarotene, 41% (24 of 59 subjects) with 0.01% tazarotene, 55% (32 of 58 subjects) with 0.05% tretinoin, and 22% (13 of 58 subjects) with vehicle. Local adverse events, although more frequent with tazarotene at higher concentrations, were generally mild to moderate. CONCLUSIONS Tazarotene in a cream formulation is safe and is associated with positive changes in the treatment of photodamaged facial skin.