Efalizumab

Alefacept

Adalimumab

Etanercept

Infliximab

General Psoriasis

References
Ongoing Developments in Biologic Therapy




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Meetings/Links : Meeting Reports : Highlights of Posters on Biologics and Psoriasis from the 64th Annual Meeting of the American Academy of Dermatology
Highlights of Posters on Biologics and Psoriasis from a
Meeting held on March 3-7, 2006
San Francisco, California
by Jennifer Clay-Cather, MD

Efalizumab

Gottlieb et al (P44)1 evaluated the safety and tolerability of extended efalizumab therapy in patients with chronic moderate to severe plaque psoriasis. This was a pooled analysis of two long-term studies with efalizumab and is the largest safety compilation of psoriasis patients studied through 60 weeks of treatment with a biologic therapy. One study was conducted for 60 weeks, and the second was conducted for 36 months. The baseline demographics and psoriasis characteristics of the patients enrolled in the two studies were similar. In one study, there was a 12-week placebo-controlled period and then a 48-week open-label period. Patients received 1 mg/kg/wk efalizumab after the single conditioning dose of 0.7 mg/kg. Patients were then able to enter a 12-week treatment-free observation period or could continue to receive drug. In the 36-month trial, patients received 2 mg/kg/wk for the first 12 weeks, and those patients achieving PASI 50 or PGA of mild, minimal, or clear were then eligible for the maintenance period, which consisted of an additional 30 months of therapy. During the maintenance period, patients were continued on 1 mg/kg/wk unless they dropped below a PASI 50, in which case the dose could be increased to 2 mg/kg/wk. However, subsequent studies have shown that there is no added improvement at this dose. The final 3-month period was a transition period in which patients were transitioned to commercial drug or alternative therapy. Concomitant topical or phototherapy was permitted in both studies.

The most common adverse events were those defined previously as acute events, such as headache, fever, chills, nausea, and myalgia occurring within 48 hours of receiving a dose of efalizumab. No new adverse events appeared during the maintenance periods of these studies. One case of hemolytic anemia (0.1%) was reported with 25 to 36 weeks of therapy, and 8 cases of thrombocytopenia (0.8%) were reported. The incidence of infection, arthritis, malignancy, or psoriasis within any 12-week period was similar to that observed in individual clinical trials with shorter duration (Table 1).

Table 1. Incidence of Selected Adverse Events Occurring Within Each 12-Week Treatment Period in the Combined Population


Papp et al (P2836)2 assessed whether efalizumab had any effect on arthropathy adverse events. Safety data from more than 3,300 patients treated with efalizumab in 9 different trials were analyzed. Arthropathy adverse events were defined by the investigators variously as arthritis arthrosis, arthritis (not otherwise specified), psoriatic arthropathy, arthropathy (not otherwise specified) monoarthritis, polyarthritis, and osteoarthritis. All of these terms were included. The studies were divided into treatment periods defined as FT (first treatment of 0 to 12 weeks), ET (extended treatment of 13 to 24 weeks), LT (continuous long-term treatment up to 36 months, analyzed in 12-week segments), FE (first exposure), and RT (retreatment). In general, patients received 1 mg/kg/wk except during ET or RT, when they may have received 2 mg/kg/wk. Patient demographics and psoriasis characteristics were comparable between all of these studies, allowing for pooling of the data.

The proportion of patients reporting an adverse event (AE) of arthropathy was similar between efalizumab and placebo in the FT 1 mg/kg/wk group (3.5% for placebo vs 3.2% for efalizumab). Patients in the ET or RT groups who received 1 or 2 mg/kg/wk also did not show an increased incidence of arthropathy AEs compared to placebo in the 12-week period. Patients in the LT group also did not show an increased incidence in arthropathy AEs over time, and levels continued to be comparable to the FT placebo group.

The effect of a previous history of arthropathy was evaluated, and in the FT period a similar proportion was seen between the placebo and efalizumab groups (88% for placebo and 76% for efalizumab). Patients experiencing an arthropathy AE were more likely to have had a previous history of arthropathy. A correlation between degree of response and occurrence of arthropathy AEs was also found (Figure 1).

Figure 1. Arthropathy adverse events related to prior history of arthropathy and clinical response.


A study by Broder et al (P2842)3 looked at the impact of first-line biologic choice on the pharmacy budget. This was a cost-minimization analysis using a model of 100 patients with moderate to severe psoriasis who would begin their therapy with either efalizumab or etanercept. Patients who failed to respond to therapy with the first biologic after 6 months would then be switched to the second agent (Figure 2).

Figure 2. Cost-minimization model comparing choice of first-line biologic for psoriasis.


PASI 50 was used as the criterion for assessing the number of patients who would switch therapies. The assumption was made that all patients who did not achieve a PASI 50 at 24 weeks would switch to the other agent. The model also used the clinical trial data to assume the number of patients who would achieve a PASI 50 response.

The analysis showed that if etanercept were the first-line biologic agent, the cost to the health plan to treat 100 patients for 24 weeks would be $1.35 million. The model further assumed that all patients who received etanercept would be able to reduce their dose from 50 mg BIW to 50 mg QW after 12 weeks of therapy. Based on the reported efficacy in clinical trials, 77% of patients would achieve PASI 50 and continue on etanercept for another 28 weeks, for a cost of $0.81 million. The remainder of the patients would be switched to efalizumab, for a cost of $0.26 million. The total annual cost for the 100 patients would be $2.4 million.

On the other hand, if efalizumab were the first agent used, treating 100 patients for the first 6 months would cost $0.95 million. Based on clinical trial data, 67% of patients would achieve PASI 50 and continue on efalizumab for the next 28 weeks at an additional cost of $0.74 million. The patients who failed would be switched to etanercept at a cost of $0.49 million, for a total annual treatment cost of $2.2 million. Thus, using efalizumab first could reduce the cost by $0.22 million for 100 patients. This cost savings would be even greater if one factors in the number of patients who could not successfully have their dose of etanercept monotherapy reduced at week 12 as per the labeling. For each 10% decrease in the proportion of etanercept users who stepped down, the efalizumab-first strategy saved an additional $1060 per treated patient. A series of posters presented individual case reports. These included a single case report (Robins, P594)4 of successful treatment of hidradenitis suppurativa, four case reports of successful treatment of hand and foot psoriasis (Sobell et al, P2864)5, a case report of successful treatment of chronic recalcitrant pyoderma gangrenosum (Woodson, P604),6 and a case report of successful treatment of atopic dermatitis (Hamilton, P831).7

Alefacept

A number of posters described the use of alefacept in combination with narrowband ultraviolet B (NB-UVB). One such study evaluated the use of NB-UVB in combination with alefacept in 16 patients (Jacobe, P2876).8 NB-UVB was given 3 times per week for 12 weeks. However, based on response, this could be reduced to once or twice a week. Alefacept was given at 15 mg IM. Half of the patients were given placebo, and half were given alefacept with NB-UVB. With NB-UVB, there was a 54.5% decrease in PASI at week 4 compared to a 22.6% decrease in the placebo group. The two groups were equivalent at weeks 12, 16, and 20. Thus, the authors concluded, a more rapid response is obtained when NB-UVB is added to alefacept. Another study of 12 patients (Moore et al, P2856)9 confirmed these results, based on using decrease in BSA as the clinical end point.

Korman et al (P2912)10 conducted an interim analysis of a large clinical trial that reviewed the use of alefacept in combination with UVB or retinoids. Patients were given three courses of therapy: 23 patients received alefacept plus UVB, and 23 received alefacept plus retinoids. The percentage of patients achieving a PGA of clear or almost clear for each course of therapy in combination with UVB or retinoids is presented in Table 2.

Table 2. PGA Response With Alefacept Plus Concomitant UVB or Retinoids


Another series of posters examined different doses or dosing schedules of alefacept. A study by Gribetz et al (P2824)11 examined the maintenance of response in patients receiving 16 weeks of alefacept. Twenty patients enrolled into the study and received 12 weeks of alefacept 15 mg/wk IM. Then 10 patients were continued on alefacept for an additional 4 weeks. After 24 weeks, patients could enter an optional 28-week observation period, for a total study time of 52 weeks. Four patients from the 16-week treatment group and 3 from the 12-week treatment group were followed. The study found that patients who responded to the extended course of therapy maintained this response longer (up to 36 weeks) than those with the shorter course of therapy.

Menter et al (P42)12 examined the effects of 3 courses of alefacept therapy. The percentage of patients achieving a PGA of clear or almost clear at week 14 was 16% for the first course, 22% for the second course, and 19% for the third course. At week 24, the percentages increased to 35%, 42%, and 42%.

Another study (Feldman et al, P2859)13 examined the use of 30 mg IM alefacept for 12 weeks, compared to 30 mg IM for 6 weeks followed by 15 mg IM for 6 weeks. Sixteen patients completed the study. At week 14, a PASI 50 was achieved by 44% of the patients and there was no difference between the two doses. In another study reported in the same poster, patients were given 10 mg IM alefacept for 16 weeks. By week 20, it was found that 11/18 (61%) patients had achieved a PASI 50 and 17% had achieved a PASI 75.

A study conducted by Sweetser et al (P2907)14 evaluated pharmacokinetic and pharmacodynamic equivalence of subcutaneous (SQ) alefacept versus IM alefacept in healthy volunteers. The doses were found to be bioequivalent by all parameters tested, including mean total lymphocyte counts.

Strober et al (P2903)15 reviewed several studies addressing the issue of T-cell monitoring with alefacept, specifically, reducing the monitoring of T-cell counts. In one study, if patients had a CD4 count greater than 400 cells/mm3, then no further monitoring was done for the remaining weeks of the 12-week course of therapy. If the CD4 count was less than 400 cells/mm3, then monitoring was performed every 2 weeks. There was no difference in infection rates or other adverse events between the groups and no cumulative effect of multiple courses of therapy. Currently, in 2 other studies, T cells are being monitored every 4 weeks. Results are pending

Adalimumab

Gladman et al (P40)16 reported on the subanalysis of moderate versus severe psoriasis in the ADEPT trial, which studied adalimumab given for 24 weeks to improve skin and joint disease in patients with psoriatic arthritis. The objective of this subanalysis was to determine if the treatment of psoriasis varies with the baseline severity of the skin disease in these patients. Patients in this trial received adalimumab 40 mg every other week (eow) or placebo. Patients completing 24 weeks of therapy were eligible to enter an open-label extension study. At week 24, response was analyzed based on baseline PASI of <10 or ≥10. The PASI 50, 75, and 90 responses were similar in both groups (Figure 3).

Figure 3. PASI responses at week 24 by disease severity.


Mease et al (P2865)17 evaluated the efficacy and safety of adalimumab in the treatment of moderate to severe psoriatic arthritis. These data are also from the ADEPT trial (P40, above). PASI responses had rapid onset and were maintained during 48 weeks. The percentage of patients achieving PASI 75 was 58% for adalimumab at week 48 compared to 59% at week 24. Half of these patients had a baseline use of methotrexate. At week 48, PASI 75 was achieved by 69% of patients who had been on methotrexate versus 50% of those who had not.

A study by Melilli et al (P2894)18 looked at the minimum clinically important difference (MCID) in Dermatology Life Quality Index (DLQI) in moderate to severe plaque psoriasis patients treated with adalimumab. This study was designed to assess the sensitivity of the DLQI and to determine an MCID for use in future trials. At the end of the trial, data for 140 patients were analyzed, and it was found that there was a correlation between PGA response and DLQI score. Those with minimal response did better than nonresponders. MCID was determined to be between 2.3 and 5.7, based on the mean range in DLQI for those with a minimal PGA response.

A number of posters on psoriatic arthritis and rheumatoid arthritis were presented and are not being reviewed, as the focus of this review is psoriasis.

Etanercept

Leonardi et al (P2861)19 assessed the response variability in patients treated with step-down etanercept therapy. This was a retrospective analysis of a multicenter double-blind study. The study was closed at 36 weeks, with the number of patients dropping sharply after 36 weeks. PASI scores and BSA from weeks 12 to 36 and from weeks 12 to 48 were reviewed, with data from 194 patients presented. PASI 75 at weeks 12, 36, and 48 varied from 48% to 40%. Mean PASI score was 5.6 at week 12, 5.4 at week 36, and 6.9 at week 48. Mean BSA score was 10.2 at week 12, 7.8 at week 36, and 6.9 at week 48. (Figure 4). Thus, the aggregate data indicate that PASI scores remained basically stable and BSA improved slightly from weeks 12 to 36.

Figure 4. Effect of step-down etanercept dosing.


However, the patient group behavior obscures the individual patient responses. An analysis of PASI 75 responders at 12 weeks was conducted at 36 weeks. Patients were evaluated in terms of disease improvement versus return of disease. Approximately 12% of initial responders experienced a worsening of PASI score by 5 points or greater from week 12 to week 36. Approximately 32% of patients experienced a worsening of PASI score of 2 points or more. Thus, in total, approximately 59% of patients experienced some worsening of their disease between weeks 12 and 36.

Griffiths et al (P2892)20 evaluated response to therapy in patients who had participated in phase 3 trials and had received 60 weeks of therapy. These patients were then enrolled in a 72-week open-label extension study. Patients received 50 mg etanercept once a week (QW) for 12 weeks with the option of increasing to 50 mg twice a week (BIW) thereafter. Five-hundred ninety-one patients increased their dose to 50 mg BIW, and 321 remained at the dose of 50 mg QW. In general, the patients who increased their dose had more severe disease upon entry into the extension phase of this study. The proportion of patients who achieved a PGA of 0 or 1 increased from 44% at entry to 64% at week 72 for the 50-mg QW group and increased from 26% at entry to 46% at week 72 for the 50-mg BIW group. The authors concluded that some patients may benefit from an increase in dose to 50 mg BIW. This study also showed that sustained improvement in patient-reported outcomes (DLQI) were seen for up to 132 weeks of therapy.

Elewski et al (P2908)21 reported on the PASI findings of the same extension study as in the poster above (P2892). A total of 912 (74%) patients enrolled in the extension study, with 591 patients increasing their etanercept dose at some point after 12 weeks of etanercept 50 mg/wk (QW/BIW group) and 321 patients maintaining their weekly 50-mg dose of etanercept through week 72 (QW group). Because most patients had increased to etanercept 50 mg BIW because they had not achieved PASI 75 at week 12 of the extension study (versus baseline of the original study), results for these patients were further analyzed.

PASI 75 in the QW group was 61% at week 12, 68% at week 48, and 60% at week 72. PASI 75 in the QW/BIW group was 33% at week 12, 44% at week 48, and 43% at week 72. The numbers are lower in the QW/BIW group, since those responding well stayed on QW dosing and those not responding as well were more likely to increase the dose.

Tyring et al (P39)22 described the results of a 96-week study of the safety and efficacy of etanercept 50 BIW. This study is planned to continue at 50 mg QW or BIW from weeks 96 to 144 (3 years). The first 12 weeks were placebo-controlled and blinded, after which the trial was open-label, with both groups eligible to receive etanercept 50 mg BIW. In the etanercept-treated patients, the PASI 75 was 47% at week 12, 60% at week 24, 63% at week 48, and 51% at week 96. Adverse events were reviewed as exposure-adjusted rates for 100 patient-years, and there were no differences from placebo with the exception of injection-site reactions. No neutralizing antibodies were seen.

Gordon et al (P2875)23 evaluated the effectiveness and safety of continuous versus intermittent etanercept therapy in patients with psoriasis in a multicenter, randomized, open-label 24-week study. For the first 12 weeks, all patients received etanercept 50 mg BIW. The continuous therapy group received etanercept 50 mg QW for the next 12 weeks. In the intermittent therapy group, patients who were considered responders discontinued therapy, but if they relapsed, they were placed on 50 mg QW. At week 24, 71% of those in the continuous therapy group were considered responders, and 59.6% of those in the intermittent therapy group were considered responders, as measured by PGA of clear or almost clear.

Elewski et al (P2884)24 also studied the effect of interruption of etanercept therapy, by measuring the effect that length of time of interruption had on response rates. In this study, patients had ≤30 days' interruption and 343 patients had >30 days' interruption of therapy. Patients who had a longer interruption entered the extension study with worse baseline PASI scores. By week 24 of therapy, the two groups had equal response rates and retained these response rates for the 72 weeks of the study. Additional studies also reported on the effect of interruption of therapy on various efficacy measures. The conclusions were consistent among all the analyses performed.

An Italian study by Costanzo et al (P2831)25 evaluated the effect of previous biologic therapies on the rate of response to etanercept. Previous infliximab therapy resulted in a poor response to etanercept. The effect was not correlated with any reason for switching therapy. Previous efalizumab therapy did not influence response to etanercept. Response to infliximab was also not affected by the previous use of etanercept. Based on this small study, the authors concluded that there might be a rational order in which biologic agents should be used.

A number of studies looked at subgroups of patients and effect on response. In a study by Lebwohl et al (P2881),26 the presence or absence of psoriatic arthritis had no effect on response. Strober et al (P2890)27 found that baseline PASI, BSA, PGA, or prior nonbiologic therapy also had no effect on response.

Infliximab

Gottlieb et al (P43)28 presented the 1-year phase 3 results of the EXPRESS II infliximab study (P43) in which patients received induction doses of 3 mg/kg or 5 mg/kg at weeks 0, 2, and 6. Patients were then randomized at week 14 to receive either 3 mg/kg every 8 weeks or PRN or 5 mg/kg every 8 weeks or PRN. The last dose was given at week 46, and patients were evaluated at week 50. The PASI 75 at week 50 is shown in Figure 5. The only adverse event of note in long-term therapy was elevated ALT levels in 4.9% of patients.

Figure 5. PASI 75 response with infliximab at 2 doses and 2 dosing regimens.


Menter et al (P2872)29 assessed the consistency of response of infliximab 5 mg/kg between the EXPRESS and EXPRESS II trials. PASI 75 through week 50 was very consistent between the two studies.

Leonardi et al (P2888)30 evaluated the ability to regain response after loss of response in the PRN group of patients in the same 2 studies. In both the 3-mg/kg and the 5-mg/kg groups, patients were able to regain response when treated; however, the patients in the 5 mg/kg group achieved a better response: PASI 75 4 weeks after first PRN dose was attained by 38.1% of patients in the 3-mg/kg group and 59.4% of patients in the 5-mg/kg group.

Gordon et al (P2889)31 reviewed the safety data from all four clinical trials. The only significant difference in adverse events when compared to the 16-week placebo-controlled period was the incidence of infusion reactions.

Reich et al (P2871)32 looked at the consistency of response across subgroups of patients. Age, gender, BMI, baseline psoriasis severity, presence of psoriatic arthritis, number of prior systemic therapies, and previous psoriasis medications had no effect on PASI response at 10 weeks.

Siu et al (P2806)23 evaluated etanercept as a cyclosporine-sparing agent in a very small number of patients with mixed results.

General Psoriasis

Robinson et al (P2822)34 evaluated the incidence of cardiovascular risk factors in psoriasis patients from 2 large healthcare claims databases compared to controls. Risk factors included atherosclerosis, type 2 diabetes, and hypertension. The odds ratio was 1.3 for atherosclerosis, 1.2 for hypertension, and 1.2 for diabetes, indicating a higher incidence of these risk factors in psoriasis patients than in the control population.

To determine a difference between the definition of severe and very severe psoriasis, Kulkarni et al (P2800)35 examined a survey conducted by the National Psoriasis Foundation of 400 psoriasis and psoriatic arthritis patients. To date, severe is defined as a BSA >10%, and very severe is defined as a BSA of >20%. The Koo Menter Psoriasis Instrument (KMPI) score was used to evaluate the impact of disease on the patient. The study concluded that there is considerable overlap in KMPI score between severe and very severe, especially when the KMPI is over 50, indicating a significant impact on quality of life and the need for systemic therapy.

In a study by Bort et al (P2825),36 the management of psoriasis with different and consecutive anti-TNF agents was evaluated in 14 patients: 4 patients went from infliximab to etanercept, 3 went from infliximab to adalimumab, 2 went from etanercept to infliximab, and 1 went from etanercept to adalimumab. The patients were on therapy from 20 to 29 months (mean 19.2 months). Of the 14 patients, 3 developed antinuclear antibodies to infliximab; 6 responded to the first agent used, 3 responded to the second agent, and 2 responded only to the third agent used. Of the 8 who had no response to the first agent, 5 responded to the second agent, 3 did not respond to the first or second agent, but 1 did respond to the third agent. Overall, 78.5% of patients responded to either the first or second agent used or to both of them.

References
  1. Gottlieb A, Hamilton T, Rafal E, et al. Safety and tolerability of extended efalizumab therapy in patients with chronic moderate to severe plaque psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P44.
  2. Papp K, Hamilton T, Casset-Semanaz F, et al. Safety analysis of efalizumab in the incidence of adverse events for arthropathy: a pooled analysis of 7 clinical trials. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2836.
  3. Broder M, Yu EB, Laouri M, et al. The impact of first-line biologic choice on pharmacy budget. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2842.
  4. Robins D. Successful treatment of hidradenitis suppurativa with efalizumab: a case report. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P594.
  5. Sobell J, Fretzin S. Case studies of efalizumab in hand and foot psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2864.
  6. Woodson J. Use of efalizumab for the successful treatment of chronic recalcitrant pyoderma gangrenosum. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P604.
  7. Hamilton T. Successful treatment of atopic dermatitis with efalizumab. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P831.
  8. Jacobe H, Winterfield L. Efficacy and safety of alefacept in combination with narrowband UVB for the treatment of plaque psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2876.
  9. Moore A, Slay D, Wright E, et al. Alefacept and narrowband UVB combination therapy for psoriasis shortens onset of action. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2856.
  10. Korman NJ, Koo JYM, van de Kerkhof P, et al. The efficacy and safety of alefacept in combination with UVB light or systemic retinoids. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2912.
  11. Gribetz C, Lebwohl M. Maintenance of response in patients with chronic plaque psoriasis after an extended 16-week course of alefacept. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2824.
  12. Menter A, Lebwohl M. Efficacy and safety of up to three courses of intramuscular alefacept. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P42.
  13. Feldman S, McCarty A, Carroll C, et al. An open-label study evaluating an extended course of high-dose alefacept for the treatment of psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2859.
  14. Sweetser M, Ticho H, Swan S. Subcutaneous administration of alefacept is bioequivalent to intramuscular administration: results of a randomized, open-label, crossover study in healthy volunteers. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2907.
  15. Strober B, Menter A, Schear N, et al. Reduced T-cell monitoring schedules for patients treated with alefacept. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2903.
  16. Gladman D, Mease P, Kavanaugh A, et al. Adalimumab is efficacious in treating skin disease in psoriatic arthritis: subanalysis of moderate versus severe psoriasis in the ADEPT trial. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P40.
  17. Mease P, Gladman D, Ritchlin C, et al. Clinical efficacy, safety and inhibition of joint destruction of adalimumab in the treatment of moderate to severe psoriatic arthritis: 48-week results of the ADEPT trial. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2865.
  18. Melilli L, Shikiar R, Thompson C. Minimum clinically important difference in Dermatology Life Quality Index in moderate to severe plaque psoriasis patients treated with adalimumab. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2894.
  19. Leonardi C, Noh E, Langley R, et al. Assessment of response variability in patients treated with step-down etanercept therapy over 48 weeks. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2861.
  20. Griffiths C, Papp K, Koo J, et al. Long-Term patient-reported outcomes: etanercept therapy in patients with psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2892.
  21. Elewski B, Leonardi C, Gottlieb A, et al. Sustained long-term clinical efficacy and safety for up to 2.5 years of etanercept in patients with psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2908.
  22. Tyring S, Poulin Y, Langley R, et al. A 96-week phase 3 study of safety and efficacy of etanercept 50 mg twice weekly in patients with psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P39.
  23. Gordon K, Kang S, Xia A, et al. Effectiveness and safety of continuous versus intermittent etanercept therapy in patients with psoriasis: analysis of the EASE trial. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2875.
  24. Elewski B, Leonardi C, van de Kerkhof P. Evaluation of clinical response in psoriasis patients with an interruption of etanercept treatment. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2884.
  25. Costanzo A, Papoutsaki M, Mazzotta A, et al. Previous biologic therapies influence the rate of response to etanercept in chronic plaque psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2831.
  26. Lebwohl M, Powers J, Gordon KB, et al. Etanercept therapy maintains high PASI responses in psoriasis patients independent of reported psoriatic arthritis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2881.
  27. Strober B, Gottlieb A, Leonardi C, et al. Levels of response of psoriasis patients with different baseline characteristics treated with etanercept. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2890.
  28. Gottlieb AB, Feldman S, Weinstein G, et al. Infliximab: one-year phase III results. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P43.
  29. Menter A, Matheson R, Griffiths CEM, et al. Consistency of response of infliximab 5 mg/kg maintenance therapy: data from EXPRESS and EXPRESS II. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2872.
  30. Leonardi C, Menter A, Kimball A, et al. Infliximab for the treatment of moderate to severe psoriasis: response to re-treatment. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2888.
  31. Gordon KB, Nestle FO, Guzzo C, et al. Infliximab safety experience: data from clinical trials in patients with psoriatic disease. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2889.
  32. Reich K, Gottlieb AB, Kimball A, et al. Consistency of infliximab response across subgroups of patients with psoriasis: integrated results from randomized clinical trials. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2871.
  33. Siu K, Strober B. A retrospective study to evaluate the safety, tolerability, and efficacy of the combination of cyclosporine and etanercept for the treatment of moderate to severe psoriasis. Presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Calif. Poster P2806.
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