Annotated Bibliography

Introduction

Using CCNY’s databases, we were required to find four original research articles of similar topics from peer reviewed journals. Using these articles, we had to write an annotated bibliography that summarized each of the articles, and how we can incorporate them into a literature review.

Peer Review and Instructor Feedback

Page 1Page 2Page 3These three images above are the feedback I received from my instructor for this assignmentPeer Review SheetThis is my peer review sheet for this assignment

Final Draft

Efficacy of Secukinumab on Plaque Psoriasis: Annotated Bibliography

Bissonnette R, Luger T, Thaçi D, Toth D, Lacombe A, Xia S, Mazur R, Patekar M, Charef P, Milutinovic M. 2018. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE extension study). J. Eur. Acad. Dermatol. Venereol. [accessed 2018 Apr 23]. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/jdv.14878

In this research paper, Dr. Robert Bissonnette and his team conducted a five-year study on the efficacy of secukinumab on plaque psoriasis. Dr. Bissonnette works for Innovaderm Research Inc., a clinical research organization that specifically studies dermatological conditions. Dr. Bissonnette’s research is unique because he recognizes the fact that psoriasis is a long-term illness that needs long-term treatment. Therefore, his five-year study is an accurate representation of how the medication would be practically used on a patient. The results collected show that secukinumab is effective in treating visible plaques and improvements in patient quality of life. This study’s main upsides are that it is the only long-term study on secukinumab and it has a low subject dropout rate of 4%. The main limitation of this trial is that the subjects were carefully selected, ensuring there was no prior antibody treatment, etc. which does not accurately represent the population of psoriasis patients. The research does not have any issues with its methods, and the results are not misinterpreted. The research paper is useful because its data is very new, so it provides confirmation on what the other articles in this review state. It also provides insight about the dosages that should be used when prescribing secukinumab. From the study, it seems that 300 mg dosages are effective and safe over long periods of time.

Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, Antoni C, Draelos Z, Gold MH, Durez P. 2010. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci. Transl. Med. [accessed 2018 Apr 23];2(52). Available from: http://stm.sciencemag.org/content/2/52/52ra72.full

Dr. Wolfgang Hueber works for Novartis Pharmacology in Switzerland. With his team, he was able to develop the monoclonal antibody that targets the IL-17A protein. This study was the first ever conducted on secukinumab, formerly known as AIN457. The aim of this initial study was to determine if IL-17A was responsible for inflammatory diseases such as psoriasis. 36 patients with plaque psoriasis were split into two groups. One group received a 3 mg/kg dosage of AIN457 while the other group received a placebo. After 12 weeks, approximately 75% of patients who received the AIN457 treatment showed a significant increase in clearer skin compared to the placebo group. Similar tests were conducted on individuals with rheumatoid arthritis and uveitis, and patients experienced positive results. Since this experiment was the first one testing this medication, there was a small group of patients willing to participate, which means extrapolation of the experimental data is not representative of the overall population. Another issue with this trial was that the strength of the medication was still unknown, so very low dosages were administered which could have inhibited potential benefits. Fortunately, there were no deaths during the study, signifying AIN457 as a viable option for further research. It also means that people will be more likely to participate in future studies since it’s a safe medication. This research provides the foundation and early history of secukinumab, which can be used with the other articles to analyze how the medication has developed into a sustainable treatment and how the experimental studies are more carefully designed to analyze how secukinumab affects certain aspects of health and disease.

Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B. 2014. Secukinumab in plaque psoriasis — results of two phase 3 trials. N. Engl. J. Med. [accessed 2018 Apr 23];371(4):326–338. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa1314258

Dr. Richard Langley and his team conducted a phase III trial, which tested the efficacy of secukinumab on a large group of people. Dr. Langley is affiliated with the Dalhousie University in Canada. In the study, there were two double-blind trials called ERASURE and FIXTURE. 738 patients from ERASURE and 1306 patients from FIXTURE were selected for the study. These patients were given one of the following dosages of medication: 300 mg of secukinumab, 150 mg of secukinumab, placebo, or 50 mg etanercept injection. This study aimed to show that secukinumab is significantly more effective than the placebo and etanercept over a 52-week period. The following data was collected and demonstrates the percentage of patients who met PASI 75 by week 12 of the study.

PASI 75 at Week 12

ERASURE

 FIXTURE
81.6% with 300 mg of secukinumab 77.1% with 300 mg of secukinumab
71.6% with 150 mg of secukinumab, 67.0% with 150 mg of secukinumab
4.5% with placebo 44.0% with etanercept

4.9% with placebo

The data shows that significantly more patients experienced clearer skin with either dosage of secukinumab compared to the placebo and etanercept. This study was a phase III trial, which means that secukinumab was not FDA approved when this study was conducted. Therefore, it was necessary that this trial proved the medication’s safety and efficacy.  Dr. Langley and his team proved that secukinumab works safely and it targets the correct protein (IL-17A) that may cause psoriasis, which marks a crucial point in the medication’s development. This article would provide more data on secukinumab efficacy, and the statistics that guaranteed FDA approval.

Thaçi D, Blauvelt A, Reich K, Tsai T-F, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R. 2015. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J. Am. Acad. Dermatol. [accessed 2018 Apr 23];73(3):400–409. Available from: https://www.sciencedirect.com/science/article/pii/S0190962215016837

Dr. Diamant Thaçi and his team conducted a study comparing the efficacy of secukinumab to ustekinumab. Dr. Thaçi is affiliated with the Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lubeck, Germany. Ustekinumab is also a monoclonal antibody like secukinumab, but ustekinumab targets IL-12 and IL-23, whereas secukinumab targets IL-17A. The study was conducted with 676 people where half the group got one medication, while the other half got the other. The study was conducted for 16 weeks, and in each group, the number of people who achieved PASI 90 (90% reduction of psoriasis) was counted. The results showed that the secukinumab group had 79% of individuals with PASI 90, while the ustekinumab group had 57.6%. In general, secukinumab had significantly better results than ustekinumab. This type of study is extremely important because it confirms the efficacy of secukinumab and it suggests it is the most viable option amongst potential medications, which makes it a useful paper to include on the efficacy of secukinumab. This study also builds on the Langley study because in that trial secukinumab’s efficacy over etanercept was confirmed, while this study does the same against ustekinumab. These results provide patients with a basis for their treatment plans and how they choose to deal with their psoriasis. Unfortunately, this study was very short, so the results could be skewed, however, the Bissonette study shows that secukinumab is effective long-term.

Self Assessment

For this assignment, I was able to enhance my ability to research articles and databases. I was able to accurately summarize all the papers and evaluated them. Initially I had trouble reaching the word count; however, after working with my peers I was able to find places in my writing that needed more explanation, mainly the part where I evaluate how I am going to use the paper in my literature review.

Another part of this assignment that I struggled with was creating the CSE citations. Initially, I was confused by what to include, but after using the book and in-class exercises, I was able to correctly create the citations.

Overall, this assignment gave me an opportunity to understand each of my articles and how I will use them for my literature review.