Psoriasis: Korman NJ

Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R, Anonymous00035. · Baylor University Medical Center, Dallas, Texas, USA. · J Am Acad Dermatol. · Pubmed #19217694 No free full text.

Abstract: Psoriasis is a common, chronic, inflammatory, multi-system disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this third of 6 sections of the guidelines of care for psoriasis, we discuss the use of topical medications for the treatment of psoriasis. The majority of patients with psoriasis have limited disease (<5% body surface area involvement) and can be treated with topical agents, which generally provide a high efficacy-to-safety ratio. Topical agents may also be used adjunctively for patients with more extensive psoriasis undergoing therapy with either ultraviolet light, systemic or biologic medications. However, the use of topical agents as monotherapy in the setting of extensive disease or in the setting of limited, but recalcitrant, disease is not routinely recommended. Treatment should be tailored to meet individual patients' needs. We will discuss the efficacy and safety of as well as offer recommendations for the use of topical corticosteroids, vitamin D analogues, tazarotene, tacrolimus, pimecrolimus, emollients, salicylic acid, anthralin, coal tar, as well as combination therapy.

Doherty SD, Van Voorhees A, Lebwohl MG, Korman NJ, Young MS, Hsu S, National Psoriasis Foundation. · Department of Dermatology, Baylor College of Medicine, Houston, Texas 77030, USA. · J Am Acad Dermatol. · Pubmed #18485527 No free full text.

Abstract: BACKGROUND: Chronic immunosuppression is a known risk factor for allowing latent tuberculosis (TB) infection to transform into active TB. Immunosuppressive/immunomodulatory therapies, while highly efficacious in the treatment of psoriasis and psoriatic arthritis, may be associated with an increased rate of active TB in patients receiving some of these therapies. OBJECTIVE: Our aim was to arrive at a consensus on screening for latent TB infection in psoriasis patient treated with systemic and biologic agents. METHODS: Reports in the literature were reviewed regarding immunosuppressive therapies and risk of TB. RESULTS: Screening patients for latent TB infection before commencement of treatment is of utmost importance when beginning treatment with the tumor necrosis factor-alpha inhibitors, T-cell blockers, cyclosporine, or methotrexate. The currently recommended method for screening is the tuberculin skin test. It is preferable that positively screened patients be treated with a full course of latent TB infection prophylaxis before immunosuppressive/immunomodulatory therapy is initiated. However, in the opinion of many experts, patients may be started on the immunosuppressive/immunomodulatory therapy after 1 to 2 months, if their clinical condition requires, as long as they are strictly adhering to and tolerating their prophylactic regimen. LIMITATIONS: There are few evidence-based studies on screening for latent TB infection in psoriasis patients treated with systemic and biologic agents. CONCLUSIONS: The biologic TNF-alpha inhibitors are very promising in the treatment of psoriasis. However, because TNF-alpha is also an important cytokine in preventing TB infection and in keeping latent TB infection from becoming active disease, the use of TNF-alpha inhibitors has been associated with an increased risk of developing active TB. A higher incidence of TB has also been reported with other immunosuppressive/immunomodulatory treatments for psoriasis. It is, therefore, of utmost importance to appropriately screen all patients for latent TB infection prior to initiating any immunologic therapy. Delaying immunologic therapy until latent TB infection prophylaxis is completed is preferable. However, if the patient is adhering to his prophylactic regimen and is appropriately tolerating the regimen, therapy may be started after 1 to 2 months if the clinical condition requires.

Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. · Department of Dermatology, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA. · J Am Acad Dermatol. · Pubmed #18423261 No free full text.

Abstract: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this second of 5 sections of the guidelines of care for psoriasis, we give an overview of psoriatic arthritis including its cardinal clinical features, pathogenesis, prognosis, classification, assessment tools used to evaluate psoriatic arthritis, and the approach to treatment. Although patients with mild to moderate psoriatic arthritis may be treated with nonsteroidal anti-inflammatory drugs and/or intra-articular steroid injections, the use of disease-modifying antirheumatic drugs, particularly methotrexate, along with the biologic agents, are considered the standard of care in patients with more significant psoriatic arthritis. We will discuss the use of disease-modifying antirheumatic drugs and the biologic therapies in the treatment of patients with moderate to severe psoriatic arthritis.

Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, Lebwohl M, Koo JY, Elmets CA, Korman NJ, Beutner KR, Bhushan R. · Baylor University Medical Center, Dallas, Texas, USA. · J Am Acad Dermatol. · Pubmed #18423260 No free full text.

Abstract: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this first of 5 sections of the guidelines of care for psoriasis, we discuss the classification of psoriasis; associated comorbidities including autoimmune diseases, cardiovascular risk, psychiatric/psychologic issues, and cancer risk; along with assessment tools for skin disease and quality-of-life issues. Finally, we will discuss the safety and efficacy of the biologic treatments used to treat patients with psoriasis.

Kimball AB, Gladman D, Gelfand JM, Gordon K, Horn EJ, Korman NJ, Korver G, Krueger GG, Strober BE, Lebwohl MG, Anonymous00020. · Department of Dermatology, Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts 02114, USA. · J Am Acad Dermatol. · Pubmed #18313171 No free full text.

Abstract: There have been several articles and reports in recent months about comorbidities and risks that affect psoriasis patients in addition to their underlying disease. This piece reviews the current literature and begins to address what should be done with this new information by updating the clinician about what health screening tests, preventative exams, and referrals should be considered in this population.

Pariser DM, Bagel J, Gelfand JM, Korman NJ, Ritchlin CT, Strober BE, Van Voorhees AS, Young M, Rittenberg S, Lebwohl MG, Horn EJ, Anonymous00184. · Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA. · Arch Dermatol. · Pubmed #17310004 links to  free full text

Abstract: OBJECTIVES: A task force of the National Psoriasis Foundation Medical Board was convened to evaluate the current severity criteria of mild, moderate, and severe psoriasis and to make recommendations concerning a 2-tiered categorization of severity based on current clinical practice and related to intent to treat. PARTICIPANTS: This volunteer task force, led by David M. Pariser, MD, included Jerry Bagel, MD, Joel M. Gelfand, MD, MSCE, Neil J. Korman, MD, PhD, Christopher T. Ritchlin, MD, Bruce E. Strober, MD, PhD, Abby S. Van Voorhees, MD, and Melodie Young, MSN, RN, ANP. Meetings were held by teleconference and were coordinated and funded by the National Psoriasis Foundation. EVIDENCE: This task force reviewed psoriasis severity criteria and other published psoriasis consensus statements. Current standards of care and expert opinion were used to inform the process. CONSENSUS PROCESS: Based on meetings of the task force and under the guidance of David M. Pariser, MD, a statement was drafted by Elizabeth J. Horn, PhD, presented to the task force, and reviewed and approved by the task force. This statement was then reviewed and approved by Robert E. Kalb, MD, Gerald G. Krueger, MD, and Alan Menter, MD. The National Psoriasis Foundation Medical Board reviewed and endorsed this statement by a majority vote on March 2, 2006, at the medical board meeting. CONCLUSIONS: This clinical consensus statement proposes a 2-tiered system for plaque psoriasis therapy that reflects more accurately than the current system how patients are treated in clinical practice. This statement, focused on plaque psoriasis, is intended to assist medical professionals and insurance payers in understanding these 2 categories of patients with psoriasis and choosing appropriate therapies for these patients.

Sugiyama H, McCormick TS, Cooper KD, Korman NJ. · Department of Dermatology, Case Western Reserve University/University Hospitals Case Medical Center, Cleveland, OH 44106, USA. · Clin Dermatol. · Pubmed #18755368 No free full text.

Abstract: Alefacept is the first biologic agent approved by the US Food and Drug Administration for the treatment of psoriasis. To date, more than 1000 patients with moderate to severe psoriasis have been enrolled in phase III clinical trials of alefacept. More than 30% of patients treated with 2 courses of alefacept reached a Physician's Global Assessment of clear to almost clear, and approximately 40% and 70% of patients achieved a Psoriasis Area Severity Index score of 75 and 50 after the same regimen. Alefacept is well tolerated, and there have been no reports of significant systemic toxicity or serious treatment-related adverse events.

Robinson MR, Korman BD, Korman NJ. · Department of Dermatology, University Hospitals Case Medical Center, Murdough Family Center for Psoriasis, Cleveland, Ohio 44106, USA. · Arch Dermatol. · Pubmed #17709665 links to  free full text

Abstract: BACKGROUND: Targeted immunotherapeutic agents (TIs), also known as biological agents, are efficacious treatments for many immunologically mediated disorders, including psoriasis. In several of these diseases, including rheumatoid arthritis, Crohn's disease, and multiple sclerosis, certain TIs have been studied in combination with nonspecific immunosuppressive agents and with other TIs. OBSERVATIONS: Recently, the rheumatology, neurology, and gastroenterology literature has reported several examples of possible associated toxic effects when certain TIs are used in combination with other immunosuppressive agents. These toxic effects have included an increased risk of infection and malignancy. CONCLUSIONS: Combination therapies are often used by dermatologists. Several TIs have been approved for psoriasis; however, clinical trials using these drugs in combination with other immunosuppressive agents have not yet been performed. The implications for dermatologists of the toxic effects associated with TI combination therapy are unclear. However, combination therapy with certain TIs should be used with caution until more data are available.

Korman NJ, Moul DK. · Department of Dermatology, Case Western Reserve University/University Hospitals of Cleveland, Cleveland, OH 44016, USA. · Semin Cutan Med Surg. · Pubmed #15900794 No free full text.

Abstract: Alefacept is the first biologic therapy approved by the United States Food and Drug Administration for the management of patients with moderate-to-severe chronic plaque psoriasis. Alefacept is a fully human fusion protein with a dual mechanism of action inhibiting T-cell activation as well as selectively reducing memory T cells. More than 2000 psoriasis patients have been treated with alefacept in clinical trials. These studies reveal an excellent clinical response, with 33% of patients achieving a Psoriasis Area Severity Index (PASI) score of 75 and 57% of patients achieving a PASI 50 after one course of alefacept. Patients achieving both PASI 75 and PASI 50 have significant improvements in their quality of life. The best responders can have long remissions, and there is a tendency toward continued improvement with subsequent courses of alefacept. The safety profile over the short and intermediate term is excellent. Preliminary data regarding alternate dosing regimens, transitioning patients from conventional systemics to alefacept, and combining alefacept with ultraviolet light therapy will be highlighted. We also will discuss our practical approach to patient selection, CD4 monitoring, management of infections while on alefacept, as well as decisions regarding retreatment and combination therapy.

Price VH, Hordinsky MK, Olsen EA, Roberts JL, Siegfried EC, Rafal ES, Korman NJ, Altrabulsi B, Leung HM, Garovoy MR, Caro I, Whiting DA. · Department of Dermatology, University of California, San Francisco, California, USA. · J Am Acad Dermatol. · Pubmed #18280336 No free full text.

Abstract: BACKGROUND: Alopecia areata (AA) is a T-cell-mediated autoimmune disease. Efalizumab is a T-cell-targeted therapy approved for the treatment of psoriasis. OBJECTIVE: To assess the efficacy and safety of efalizumab in the treatment of moderate-to-severe AA. METHODS: Sixty-two patients were enrolled into this phase II, placebo-controlled trial. The trial consisted of three 12-week periods-a double-blind treatment period, an open-label efalizumab treatment period, and a safety follow-up. RESULTS: There were no statistical differences between treatment groups in percent hair regrowth, quality-of-life measures, or changes in biologic markers of disease severity after 12 or 24 weeks. In both groups, there was an approximately 8% response rate for hair regrowth (at 12 weeks). Efalizumab was well tolerated. LIMITATIONS: Numbers were too small for certain analyses. CONCLUSION: A 3- to 6-month trial of efalizumab was not effective in promoting hair regrowth in this small cohort of patients with moderate-to-severe AA.

Strober B, Berger E, Cather J, Cohen D, Crowley JJ, Gordon KB, Gottlieb A, Horn EJ, Kavanaugh AF, Korman NJ, Krueger GG, Leonardi CL, Menter A, Schwartzman S, Sobell JM, Young M. · Department of Dermatology, New York University Medical Center, New York, NY, USA. · J Am Acad Dermatol. · Pubmed #19527820 No free full text.

Abstract: Clinical trials for systemic psoriasis therapy typically enroll healthy patients and exclude patients with cardiovascular disease, latent tuberculosis, liver disease, histories of malignancies, viral infections, children, and pregnant or breast-feeding women. Physicians often require guidance for optimum management of severe psoriasis in patients that have a combination of underlying disease states. To provide treatment recommendations for complex psoriasis scenarios, a consensus panel comprising 15 experts in psoriatic disease convened to review and discuss available evidence-based data and to arrive at a consensus for treatment options of difficult cases. An application of the Delphi Method was used to select case scenarios, provide medical treatment options, present the case study with existing medical evidence, and anonymously vote on treatment options. The top 10 treatment options were ranked and statistically analyzed to compare the differences between treatments. The final rankings and analysis provide guidance for practical, safe, and efficacious treatment options in a number of complex psoriasis scenarios.

Chan CS, Van Voorhees AS, Lebwohl MG, Korman NJ, Young M, Bebo BF, Kalb RE, Hsu S. · Department of Dermatology, Baylor College of Medicine, Houston, Texas 77030, USA. · J Am Acad Dermatol. · Pubmed #19375191 No free full text.

Abstract: BACKGROUND: The scalp is the most commonly affected part of the body in patients with psoriasis. Signs and symptoms of scalp psoriasis vary significantly for individual patients. OBJECTIVE: A task force of the National Psoriasis Foundation was convened to evaluate treatment options. Our aim was to achieve a consensus for scalp psoriasis therapy. METHODS: Reports in the medical literature were reviewed regarding scalp psoriasis therapy. LIMITATIONS: There is a paucity of evidence-based and double-blind studies in the treatment of scalp psoriasis particularly for long-term therapy. Many of the studies in scalp psoriasis were designed to attain Food and Drug Administration approval for a medication and not to provide treatment guidance. CONCLUSIONS: The recommended short-term or intermittent therapy for scalp psoriasis is topical corticosteroids. The primary alternatives are topical retinoids, vitamin D analogues, and salicylic acid. Combination therapy has many advantages. The choice of an appropriate vehicle is crucial to increase patient compliance. While scalp psoriasis can often be adequately treated with topical therapy, recalcitrant disease may require more aggressive approaches, including systemic agents.

Kalb RE, Bagel J, Korman NJ, Lebwohl MG, Young M, Horn EJ, Van Voorhees AS, Anonymous00091. · Department of Dermatology, State University of New York School of Medicine and Biomedical Sciences, Buffalo, New York, USA. · J Am Acad Dermatol. · Pubmed #19103363 No free full text.

Abstract: BACKGROUND: Involvement of areas of the skin fold is common in patients with psoriasis although the exact incidence is unknown. This report summarizes studies regarding the therapy of intertriginous psoriasis. OBJECTIVE: A task force of the National Psoriasis Foundation Medical Board was convened to evaluate treatment options. Our aim was to arrive at a consensus on therapy for intertriginous or inverse psoriasis. METHODS: Reports in the literature were reviewed regarding psoriasis affecting the skin-fold areas and its therapy. LIMITATIONS: There are few evidence-based studies on the treatment of intertriginous psoriasis. RESULTS: The recommended short-term (2-4 weeks) therapy for inverse psoriasis is low- to mid-potency topical steroids. For long-term therapy, topical calcipotriene (calcipotriol) or one of the immunomodulating agents, pimecrolimus or tacrolimus, is favored. CONCLUSIONS: Low- to mid-potency topical steroids are recommended as first-line, short-term treatment. It is recommended that their use should either be of limited duration (less than 2-4 weeks) or that the lowest effective strength be used intermittently for long-term care to minimize the potential for risks. Calcipotriene (calcipotriol), pimecrolimus, and tacrolimus, while not as highly efficacious as topical steroids, are associated with fewer long-term risks and are therefore recommended for long-term therapy when feasible.

Routhouska SB, Sheth PB, Korman NJ. · Department of Dermatology, Murdough Family Center for Psoriasis, University Hospitals of Cleveland, Case Medical Center, Cleveland, OH, USA. · J Cutan Med Surg. · Pubmed #18627699 No free full text.

Abstract: BACKGROUND: Infliximab, a tumor necrosis factor alpha antagonist, has recently been shown to be successful for the short-term treatment of generalized pustular psoriasis (GPP) in multiple case reports. OBJECTIVE: The goal of this case series was to assess the efficacy of the longer-term management of GPP with infliximab. METHODS: Three patients with severe GPP were followed to assess the efficacy of long-term treatment with infliximab. RESULTS: Infliximab therapy was more efficacious with infusion every 6 to 8 weeks in combination with methotrexate. CONCLUSION: Infliximab may be efficacious for some patients for the long-term management of GPP. Maintaining a strict infliximab infusion schedule and concomitant methotrexate therapy may decrease infusion reactions and increase efficacy.

Lebwohl M, Bagel J, Gelfand JM, Gladman D, Gordon KB, Hsu S, Kalb RE, Kimball AB, Korman NJ, Krueger GG, Mease P, Morison WL, Paller A, Pariser DM, Ritchlin C, Strober B, Van Voorhees A, Weinstein GD, Young M, Horn L. · Department of Dermatology, Mount Sinai School of Medicine, New York, New York, USA. · J Am Acad Dermatol. · Pubmed #17980456 No free full text.

Abstract: 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.

Moul DK, Routhouska SB, Korman NJ. · University Hospitals of Cleveland, Case Medical Center, Cleveland, OH 44106, USA. · J Cutan Med Surg. · Pubmed #17601420 No free full text.

Abstract: BACKGROUND: Alefacept (Amevive) is a fully human LFA-3/IgG1 fusion protein with a dual mechanism of action inhibiting T-cell activation and selectively reducing memory T cells. Alefacept is currently approved as a 12-week course of weekly 15 mg intramuscular (IM) injections for the treatment of adults with moderate to severe chronic plaque psoriasis. In clinical trials using the currently approved dosing regimen, 33% and 57% of patients achieved a 75% or greater or 50% or greater reduction in Psoriasis Area and Severity Index score (PASI 75 and PASI 50), respectively, after one course of alefacept. OBJECTIVE: To evaluate the tolerability and efficacy of alefacept 15 mg IM weekly for 6 weeks followed by alefacept 30 mg IM weekly for 6 weeks. DESIGN: Open-label, single-center, dose escalation study of alefacept. PATIENTS: Adult patients with chronic plaque psoriasis involving a minimum body surface area of 10% and with a minimum PASI of 12. INTERVENTION: Patients were treated with alefacept 15 mg IM for 6 weeks followed by alefacept 30 mg IM for an additional 6 weeks; doses were held for CD4 counts < 200 cells/mm(3) or evidence of a clinically significant infection. MAIN OUTCOME MEASURE: Efficacy was evaluated by PASI and Physician Global Assessment (PGA) at baseline, week 7, and 2, 6, 12, and 24 weeks post-treatment. RESULTS: Sixteen patients were enrolled; at 6 weeks post-treatment, the PASI mean reduction was 39%, with continued improvement to 46% at 12 weeks post-treatment. The PASI 90, PASI 75, and PASI 50 responses at 12 weeks post-treatment were 6% (1 of 16), 13% (2 of 16), and 38% (6 of 16), respectively; 12% (2 of 16) of patients achieved a PGA of clear to almost clear at 12 weeks post-treatment. The overall PASI 75 and PASI 50 responses were 19% (3 of 16) and 38% (6 of 16), respectively. CONCLUSION: The treatment regimen of alefacept 15 mg IM for 6 weeks followed by alefacept 30 mg IM for 6 weeks was well tolerated by our patients. There was no increased incidence of infections when patients were treated with alefacept 30 mg compared with the 15 mg dose. The increased dose of alefacept 30 mg for the last 6 weeks of a 12-week course did not appear to yield a higher efficacy rate compared with historical controls.