Infliximab drug survival in chronic plaque psoriasis: follow‐up of the product familiarisation program

Background: Alefacept has been demonstrated in clinical trials to be an effective, safe, and well-tolerated treatment strategy when used alone or in combination with other antipsoriatic therapies in patients with chronic plaque psoriasis. Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, Canadian phase IV registry evaluating the efficacy and safety of alefacept, alone or in combination with other antipsoriatic therapies, in patients with psoriasis. Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept followed by an off-treatment period, typically lasting 12 or more weeks. Prospective follow-up was at least 60 weeks, depending on when patients presented for retreatment. Safety data collected throughout the study included the incidence of serious adverse events (SAEs), dosing suspensions, and withdrawals owing to adverse events. Results: Twelve SAEs were reported in psoriasis patients treated with at least one course of alefacept, with only one considered to be possibly related to the study drug. Approximately one-quarter of patients missed at least one dose of alefacept during the course of the study. A total of 291 doses of alefacept were missed, representing almost 4% of the total doses administered in this group of patients. Low CD4+ count was the most frequent reason for missed doses; however, no patient had persistently low CD4+ counts requiring permanent discontinuation of alefacept treatment. Seven patients in the AWARE registry discontinued treatment with alefacept, with the most common reason being patient request. Conclusion: The AWARE study supports the safety of alefacept used alone or in combination with other antipsoriatic therapies, in a broad population of real-world chronic plaque psoriasis patients in Canada.

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Efficacy Outcomes in Patients Using Alefacept in the AWARE Study

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2009.00030 ◽

2009 ◽

Vol 13 (6_suppl) ◽

pp. S122-S130 ◽

Cited By ~ 2

Author(s):

Ian Landells ◽

Gordon Searles ◽

Robert Bissonnette ◽

Neil H. Shear ◽

Ronald Vender ◽

...

Keyword(s):

Real World ◽

Plaque Psoriasis ◽

Rating Scales ◽

Treatment Modalities ◽

Chronic Plaque Psoriasis ◽

Response Data ◽

Improved Outcomes ◽

Real World Evidence ◽

Interrater Variability

Background: Alefacept has demonstrated efficacy in clinical trials of patients with chronic plaque psoriasis, either as monotherapy or combined with other treatment modalities such as phototherapy. Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, phase IV Canadian registry of psoriasis patients treated with alefacept. Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept, either alone or added on to their existing antipsoriatic treatment regimen. Each course of alefacept was followed by a period of at least 12 weeks off treatment. Efficacy outcomes included physicians' and patients' assessments of response at week 18, as well as change in percent body surface area (BSA) involvement with psoriasis. The time to retreatment was assessed in patients receiving a second course of alefacept during at least 60 weeks of prospective follow-up. Results: The majority of patients received alefacept in combination with other antipsoriatic therapies. Physicians' and patients' assessments of response at 18 weeks showed that 42% and 41% of patients, respectively, had a “cleared to marked response” and a further 42% had a “moderate to some response.” Among those patients whose psoriasis was moderately controlled or not controlled at baseline, 49 to 51% and 33 to 36%, respectively, improved to “cleared to marked response” at 18 weeks. A substantial shift in percent BSA involvement with psoriasis was observed at 18 weeks, with 55% of patients having a BSA involvement of < 10% at week 18 compared to only 20% having this level of BSA involvement at baseline. The mean time to retreatment among the 60% of patients who received a second course of alefacept was 19.3 weeks (range 2–47 weeks). Conclusion: A single course of alefacept therapy improved outcomes in this broad population of real-world chronic plaque psoriasis patients. Study Limitations: The limitations of this study include its nonrandomized, noncontrolled, noncomparative design, which allowed multiple different treatment approaches across all patients. The rating scales used in this study have not been previously validated, and ranges were assigned to baseline control and response data that are not specifically defined. Clinicians did not receive specific training in using these scales; therefore, interrater variability could not be assessed.

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In-Office Administration Associated with Increased Drug Survival of Ustekinumab for Chronic Plaque Psoriasis When Compared with Self-Administration: A Single Institution Retrospective Chart Review

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2019.10.041 ◽

2019 ◽

Author(s):

Sonal Muzumdar ◽

Reid Waldman ◽

Rong Wu ◽

Andrew Kelsey

Keyword(s):

Plaque Psoriasis ◽

Chart Review ◽

Retrospective Chart Review ◽

Self Administration ◽

Single Institution ◽

Chronic Plaque Psoriasis ◽

Drug Survival

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18189 In-office administration improves the drug survival of ustekinumab for chronic plaque psoriasis compared with self-administration: A single-institution retrospective chart review

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2020.06.458 ◽

2020 ◽

Vol 83 (6) ◽

pp. AB93

Author(s):

Sonal Muzumdar ◽

Reid A. Waldman ◽

Rong Wu ◽

Andrew Kelsey

Keyword(s):

Plaque Psoriasis ◽

Chart Review ◽

Retrospective Chart Review ◽

Self Administration ◽

Single Institution ◽

Chronic Plaque Psoriasis ◽

Drug Survival

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Comparison of a treatment phase and a follow-up phase of short-contact dithranol and calcipotriol in outpatients with chronic plaque psoriasis

Journal of Dermatological Treatment ◽

10.3109/09546639909056042 ◽

1999 ◽

Vol 10 (4) ◽

pp. 261-265 ◽

Cited By ~ 8

Author(s):

Ob Christensen ◽

N-J Mørk ◽

R Ashton ◽

F Daniel ◽

S Anehus

Keyword(s):

Plaque Psoriasis ◽

Treatment Phase ◽

Chronic Plaque Psoriasis ◽

Short Contact

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Efficacy and Safety of Apremilast versus Methotrexate in the Treatment of Chronic Plaque Psoriasis

Journal of Armed Forces Medical College Bangladesh ◽

10.3329/jafmc.v16i1.53831 ◽

2021 ◽

Vol 16 (1) ◽

pp. 39-41

Author(s):

Tawhida Nawazesh Rosie ◽

Abdul Latif Khan ◽

Md Shirazul Islam Khan ◽

Quazi Salim Yazdi ◽

ATM Rezaul Karim

Keyword(s):

Plaque Psoriasis ◽

Therapeutic Option ◽

Treatment Options ◽

Equal Treatment ◽

Military Hospital ◽

Efficacy And Safety ◽

Chronic Plaque Psoriasis ◽

Treatment Groups ◽

Proliferative Disease

Introduction: Psoriasis is a common, chronic, inflammatory and proliferative disease of the skin, also affecting nail and joints. Although there are a range of treatment options available, none have proved to wane the symptoms fully and also they reappear in course of time. Aim: To explore the safety and efficacy of Apremilast and Methotrexate on chronic plaque psoriasis patients. Methods: A randomized open clinical trial was done among fifty clinically diagnosed chronic plaque psoriasis patients in the Department of Dermatology and Venereology at Combined Military Hospital (CMH), Dhaka from 1st July 2017 to 30th June 2018. Patients were divided randomly into two equal treatment groups, 25 for Methotrexate and 25 for Apremilast. Involvement of body surface by plaque psoriasis, erythema, scaling and induration were recorded in a 3 points scale before treatment and 8 weeks after starting the treatment and finally at 12th week. Results: Reduction of psoriasis at 1st follow up in Methotrexate and Apremilast groups were 29.9±9.0 and 31.9±11.6 respectively and at 2nd follow up were 85.9±7.3 and 28.48±39.3 respectively. Significantly higher improvements were observed in Methotrexate group than Apremilast group both at 1st and 2nd follow up (p=0.001). Conclusion: Methotrexate is a better therapeutic option than Apremilast in the treatment of chronic plaque psoriasis. JAFMC Bangladesh. Vol 15, No 1 (June) 2020: 39-41

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Azathioprine weekly pulse versus methotrexate for the treatment of chronic plaque psoriasis: A randomized controlled trial

Indian Journal of Dermatology Venereology and Leprology ◽

10.25259/ijdvl_718_18 ◽

2021 ◽

Vol 0 ◽

pp. 1-6

Author(s):

Kaushal K. Verma ◽

Pramod Kumar ◽

Neetu Bhari ◽

Somesh Gupta ◽

M. Kalaivani

Keyword(s):

Randomized Controlled Trial ◽

Adverse Effects ◽

Plaque Psoriasis ◽

Controlled Trial ◽

Laboratory Evaluation ◽

Chronic Plaque Psoriasis ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Background: Methotrexate is the most commonly used drug in the treatment of psoriasis with good efficacy and safety. Recently, weekly azathioprine pulse has been shown to be effective in this disease. Aim: The aim of this study is to compare the effectiveness and safety of weekly pulse doses of azathioprine and methotrexate for the treatment of chronic plaque psoriasis. Methods: In this randomized controlled trial, 80 patients with chronic plaque psoriasis were recruited. After detailed clinical and laboratory evaluation, patients were randomized to 2 groups to receive either weekly 300 mg azathioprine (n = 40) or 15 mg methotrexate every week (n = 40) for 20 weeks, following which the response to treatment and adverse effects were assessed. The patients were then followed up every 4 weeks for 3 months to determine any relapse. Results: Overall, 48 (60%) patients achieved PASI 75, while 36 (45%) and 59 (73.8%) patients achieved PASI 100 and 50, respectively. On intention to treat analysis, PASI ≥ 75 was achieved in 47.5% (19/40) patients in group 1 compared to 85% (34/40) patients in group 2 (p < 0.001). However, on per protocol analysis, PASI ≥ 75 was achieved in 86% (19/22) patients in group 1 and 92% (34/37) patients in group 2 (p = 0.497). Minor clinical and biochemical adverse effects were noted in both the groups, which were comparable. One (7.7%) patient in group 1 and 4 (17.4%) in group 2 relapsed during follow-up. Limitations: Limitation of study include small sample size and short follow-up. Conclusion: Weekly azathioprine pulse appears to be beneficial in the management of chronic plaque psoriasis. However, it is less effective than weekly methotrexate. It can thus be of use as a therapeutic option in patients with contraindication to methotrexate or other similar agents in this disease.

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