Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2023 | Month : January | Volume : 17 | Issue : 1 | Page : WC06 - WC11 Full Version

Interleukin-17 Inhibitor in Treatment of Psoriasis during COVID-19 Pandemic: An Ambispective Study


Published: January 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/59172.17381
Ramesh Aravamudhan, V Sampath, Rajkumar Kannan, Parimalam Kumar, Venkatesan Srinivasan, MM Sridevi

1. Professor, Department of Dermatology, Madras Medical College, Chennai, Tamil Nadu, India. 2. Professor, Department of Dermatology, Madras Medical College, Chennai, Tamil Nadu, India. 3. Associate Professor, Department of Dermatology, Madras Medical College, Chennai, Tamil Nadu, India. 4. Professor and Head, Department of Dermatology, Madras Medical College, Chennai, Tamil Nadu, India. 5. Assistant Professor, Department of Dermatology, Madras Medical College, Chennai, Tamil Nadu, India. 6. Resident, Department of Dermatology, Madras Medical College, Chennai, Tamil Nadu, India.

Correspondence Address :
Dr. Rajkumar Kannan,
Department of Dermatology, Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai-600003, Tamil Nadu, India.
E-mail: sridevimmcderm@gmail.com; rajderm0002@gmail.com

Abstract

Introduction: Psoriasis is a genetically mediated chronic inflammatory disease that is frequently associated with metabolic co-morbidities. These metabolic co-morbidities have a huge impact in deciding the appropriate immunosupressant of choice in the current scenario of Coronavirus Disease (COVID-19) pandemic. Treatment of psoriasis especially with biologicals is challenging during covid pandemic since immunosuppressive therapy might interfere with antiviral immunity.

Aim: To report the safety profile of Interleukin-17 (IL-17) inhibitor, namely injection secukinumab in patients of psoriasis vulgaris during COVID-19 pandemic.

Materials and Methods: An ambispective interventional study was performed on 23 patients of psoriasis who were administered secukinumab at a dose of 300 mg subcutaneously during COVID-19 pandemic.The study was conducted at the Department of Dermatology, Madras Medical College, Chennai, Tamil Nadu, India among the patients attending the psoriasis clinic between the July 2021 to March 2022. The demographic characteristics of the study group, previous treatment for psoriasis and the relationship between risk of COVID-19 infection and secukinumab were noted. Efficacy of secukinumab was calculated using Psoriasis Area and Severity Index (PASI) scores. Statistical analysis was conducted with Statistical Package for Social Sciences (SPSS) statistics software version 21.0 by Fischer’s-exact test.

Results: Out of 23 patients, 17 patients (11 males, six females) completed full course of nine doses (five weekly doses followed by four monthly doses) of secukinumab. The PASI 75 and PASI 90 were achieved in 9 (52.94%) and 8 (29.41%) patients respectively at the end of 12 weeks. None of the patients developed COVID-19 infection during the course of treatment and three months following therapy. Patients with psoriasis who had a history of COVID-19 infection did not show signs of reinfection when started on secukinumab. Both inactivated vaccine (Covaxin) and vector based vaccine (Covishield) were found to be safe in concomitant use with secukinumab.

Conclusion: Secukinumab is found to be safe and effective in psoriasis treatment during COVID-19 pandemic. There is no increased risk of COVID-19 infection or reinfection, COVID-19 associated hospitalisation and mortality among patients with psoriasis administered with secukinumab. The drug can also be safely used with COVID-19 vaccines.

Keywords

Coronavirus disease, Psoriasis vulgaris, Psoriasis area and severity index scores, Secukinumab, Vaccine

Psoriasis vulgaris is an inflammatory skin disease affecting 1-3% of the population (1). It is caused by an inappropriate activation of T-cells and dendritic cells, leading to increase in inflammatory cytokines namely Tumor Necrosis Factor-α (TNF-α), Interleukin-17 (IL-17), Interleukin-23 (IL-23). Secukinumab which is an IL-17 inhibitor has emerged as a promising therapeutic option in chronic plaque psoriasis as well as psoriatic arthritis ensuring high efficacy, long-term maintenance of treatment response, and quick onset of action (2)

Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus is a contagious disease with variable presentations ranging from mild upper respiratory infection to severe pulmonary illness, including death. COVID-19 has been thought to worsen chronic inflammatory conditions like psoriasis due to hyperinflamation which is common in both the diseases. The immunological abnormalities seen in patients with COVID-19 are also observed in autoimmune conditions like psoriasis. Many studies have shown that the inflammatory cytokines found in psoriasis patients are similar to those involved in the cytokine storm that results in Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients (3). While the efficacy of biologicals in psoriasis is indisputable, the susceptibility to infections due to these drugs has long been a cause of concern (4).

Since, immunosuppressive and immunomodulatory therapy might interfere with antiviral immunity (5), patients under biologicals, particularly those with severe co-morbidities, might be more vulnerable to worse outcomes of COVID-19. Conversely, it has been postulated that over-activation of the immune system and production of proinflammatory cytokines like IL-17 underlies the mechanism of lung injury caused by SARS-CoV-2. Substantially high serum levels of proinflammatory cytokines like IL-17, IL-6 and TNF-α occur in almost all patients with severe COVID-19 (6). Thus, IL-17 blocking agents could be a safe and effective option in these situations.

Secukinumab, Ixekizumab and Brodalumab are the three IL-17 blockers available for use. The former two agents are monoclonal Immunoglobulin G1 (IgG1) antibodies that bind specifically to IL-17A and Brodalumab is monoclonal IgG2κ antibody against IL-17 receptor. There are a few preliminary reports on COVID-19 patients who were on secukinumab treatment for psoriasis and these patients had a favorable course (7),(8). The present study aimed to report the current status in terms of safety and efficacy in patients receiving secukinumab for moderate to severe psoriasis as well as the actual benefit and risk of IL-17 inhibitor treatment during COVID-19 pandemic.

Material and Methods

This study was an ambispective interventional study conducted in patients who were diagnosed with psoriasis vulgaris clinically and treated with secukinumab in the Department of Dermatology, Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai, Tamil Nadu, India. Patients who attended Psoriasis Clinic of Department of Dermatology between July 2021 and March 2022, were included in the study after obtaining informed consent in regional language (Tamil) and English. Study was submitted for Institutional Ethics Committee clearance (IEC No: 24122021).

Inclusion criteria:

1. Patients of age above 18 years of both gender.
2. Patients with moderate to severe plaque psoriasis (PASI score between 5-10 and PASI score >10, respectively) with or without joint involvement.
3. Patients with resistant psoriatic plaques not responding to conventional immunosuppressants.
4. Patients willing for regular follow-up and strict adherence of COVID-19 prevention protocols.

Exclusion criteria:

1. Patients with previous history of allergic reactions to secukinumab.
2. Patients who were under 18 years of age.
3. Pregnant women with psoriasis.
4. Patients who did not give consent for the study.

All the patients who fulfilled the inclusion and exclusion criteria and those who were willing to participate in the study were included. Since, all the cases were included no sampling was done.

Procedure

All the patients were thoroughly investigated and started on biologicals as per the International guidelines (9),(10), for initiation and maintenance of biologicals during COVID-19 pandemic. Selection of patients was executed after application of inclusion and exclusion criteria. Patients with psoriasis who were treated with injection Secukinumab between the month of July 2021 and March 2022 were included in the study. Enrollment of patients for the study was done in December 2021. For patients who were already on treatment (six patients) with secukinumab before the month of December, the details were collected from the previously documented hospital records (case sheets). Since, the duration of treatment with one full course of secukinumab (five consecutive weeky doses and four consecutive monthly doses) is around six months, and all the patients were in regular follow up except five (lost to follow-up), records of patients who were initiated the drug before the month of enrollment were obtained from the case sheets. These data procured in the retrospective limb of the ambispective study were critically analysed regarding the feasibility of further continuation or sustainment of injection secukinumab in the prospective limb. Data collected in prospective limb- decline in PASI following secukinumab, COVID-19 infection after secukinumab administration, reinfection in vaccinated individuals on secukinumab, if any.

Since, the data was collected in both retrospective and prospective manner, this study was an ambispective study. The duration of prospective limb was about four months and duration of retrospective limb was about five months. Twenty three (16 males and seven females) patients were included in the study of which five patients were lost to follow-up and therapy was stopped in one patient due to continuous high-grade fever. Seventeen patients completed a full course of nine doses of secukinumab 300 mg subcutaneous dose (five weekly doses followed by four monthly doses).

For all the patients, detailed history related to the duration of psoriatic lesions, previous medications for psoriasis in the form of oral antimetabolites or biologicals, history of COVID-19 infection with treatment details, vaccination for COVID-19 infection and adverse events following vaccination if any and other comorbid status were collected.

General examination with Body Mass Index (BMI), systemic examination, dermatological examinations including Psoriasis Area and Severity Index at each visit were evaluated (11). Clinical photographs were taken after obtaining informed consent. Relevant baseline investigations were done before starting the drug along with seeking for Cardiology, Hepatology and Thoracic Medicine clearance for administration of Inj. secukinumab. The drug was administered at a dose of 300 mg subcutaneously at 0, 1, 2, 3, 4 (five consecutive) weekly doses and four consecutive monthly maintenance doses.

After completion of maintenance doses (total of nine doses) the patients were followed up for three months and PASI was assessed to calculate PASI 75 (referring to a 75% or greater reduction in PASI scores from baseline) and PASI 90 (referring to a 90% or greater reduction in PASI scores from baseline) at 12 weeks to evaluate the efficacy of secukinumab.

Statistical Analysis

The data related to patient’s age, gender, PASI score, previous treatment, COVID-19 infection and COVID-19 vaccination status were entered in Microsoft Excel Sheets. Statistical analysis was conducted with Statistical Package for Social Sciences (SPSS) statistics software version 21.0 by Fischer’s-exact test.

Results

Twenty three patients were initiated for the treatment with secukinumab during the study period. The overall mean age was 35.06±9.1 years. Total males were 16 (74%) and total females were 7 (26%). Eight (34%) patients were smokers and 7 (30%) were alcoholics. About 9 (34%) patients suffered from psoriasis for more than eight years (Table/Fig 1). Ten (43%) patients had co-morbidities with majority being diabetes (17%) and psoriatic arthritis (17%).

History of COVID-19 infection before starting treatment was present in 4 (17%) patients. Three of them were treated with oral azithromycin 500 mg OD for five days and one patient was given injection dexamethasone 8 mg intravenous twice a day for five days. Five (22%) patients were administered with COVID-19 vaccine during the course of treatment of which 3 (13%) received Covishield and 2 (9%) received Covaxin. None of these patients reported adverse events following vaccination. 18 (61%) patients were neither vaccinated nor they had protective antibody to COVID-19 due to previous infection.

Nearly Half of the patients 12 (50%) had previous methotrexate therapy for psoriasis while tab. Cyclosporine and tab. apremilast were second most commonly used drugs 4 (17% each) and one patient was on infliximab (3%). General examination and systemic examination were normal in all the patients.

The mean PASI score at baseline was 16.2. There was statistically significant mean difference (p-value <0.05) between PASI at the beginning of treatment with subsequent doses (Table/Fig 2). PASI 75 was seen in 9 (52.94%) cases and PASI 90 in 5 (29.41%) cases at the end of 12 weeks (Table/Fig 3). Factors such as age, gender, duration of lesion, history COVID-19 infection, COVID-19 vaccination status, history of smoking and history of alcohol intake were not significant factors influencing PASI 75 or PASI 90 at 12 weeks (Table/Fig 4),(Table/Fig 5).

The percentage reduction in PASI was around 90% at the end of 1 month after treatment with 100% clearance of lesion in 10 patients (58.8%) (Table/Fig 6). On follow-up for three months complete remission of lesions was noted in 11 (52%) cases and relapse in 4 (17%) cases and most common site being trunk. One patient had exacerbation of lesions over extensor aspect of legs during treatment with secukinumab and was started on Tab. azathioprine 50 mg once daily for the same.

(Table/Fig 7)a,b,(Table/Fig 8)a,b,(Table/Fig 9)a,b show complete remission of back lesions with resultant post inflammatory hyperpigmentation in three patients following five weekly doses of secukinumab 300 mg.

Further, the drug was extremely effective in treating cases with nail, scalp and joint involvement, which often fails to improve with conventional treatments. In this study we found an excellent response in scalp lesions with complete resolution of psoriatic plaques after five weeks of secukinumab injections in one of the patients without any relapse (Table/Fig 10)a,b. Noteworthy, result was seen in the same patient with diffuse geographic lesions over the trunk clearing to leave behind residual postinflammatory hyer- pigmentation (Table/Fig 11)a,b.

Discussion

Psoriasis is cnow considered a systemic disease not merely confined to the skin alone. Metabolic syndrome is also being increasingly associated with it. It includes insulin resistance, systemic hypertension, dyslipidemia, abdominal obesity all of which result in increased risk of cardiovascular morbidities. Both genetic predisposition and immune mediated mechanism underlie the pathogenesis of metabolic syndrome in psoriasis patients. Mediators of Th1 and Th17 pathway like TNF-α and IL-6 involved in psoriasis antagonize insulin signaling and cause abnormal adipokine expression resulting in insulin resistance and obesity. Hyperinsulinemia, one of the components of metabolic syndrome, increases severity of inflammation in psoriatic plaques. Additionally genetic factors like PSORS4 CDKAL1 and APOE4 are common for both psoriasis and metabolic syndrome (10). Risk of atherosclerosis is more in psoriasis patients due to endothelial dysfunction occurring in the background of chronic inflammation leading to cardiovascular co-morbidities (12). All these co-morbidities can worsen the outcome of COVID-19 pneumonia.Since these comorbidities associated with activation of proinflammatory cytokine pathway like Th1 and Th17,administration of IL17 inhibitor will have a positive outcome.

Various conventional therapeutic approaches are already in use for psoriasis. The invention of biologicals like TNF-alfa inhibitors (infliximab, adalimumab, etanercept), IL-17 inhibitors (secukinumab, ixekizumab, brodalumab) made the treatment of psoriasis revolutionary. Secukinumab (monoclonal antibody to IL-17A) is widely used in India for management of psoriasis and psoriatic arthritis (13). Secukinumab was approved for use in psoriasis in 2015 in adults and in 2021 for children more than six years (14). Efficacy is particularly notable in patients who do not respond to conventional treatments. We had several patients with previous treatment with methotrexate (50%), other biologicals like infliximab (3%) who did not show much response to these drugs. Since IL-17 modulates the progression of secondary IgA nephropathy, use of secukinumab can protect against associated renal damage in chronic psoriasis patients. The drug has shown cardioprotective effects by increasing the Flow Mediated Dilation (FMD) which is a marker of endothelial function in psoriasis patients thus reducing the risk of atherosclerosis (15). It is also safe for use in latent tuberculosis and does not seem to cause increased risk of Tuberculosis (TB) reactivation (16).

Various trials suggested that, secukinumab is beneficial in patients with demyelinating disorders like multiple sclerosis by reducing the lesional activity in Magnetic Resonance Imaging (MRI) due to IL-17A blockage (17). Since, it blocks IL-17A and selectively targets the key factor pathogenesis of psoriasis, it allows meeting the goals of psoriasis management without the need to augment treatment regimens with additional agents (18).

The superiority of IL-17 inhibitors is more pronounced in terms of the proportion of patients who achieve PASI 90 and PASI 100. This is significant because these efficacy endpoints are more substantial than PASI 75 from a patient’s perspective, as demonstrated by a study finding that, patients who achieve PASI 90 and PASI 100 experience greater improvement in quality of life than PASI 75 responders (19). In ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) study, 82% and 59% patients achieved PASI 75 and PASI 90 respectively after 12 weeks therapy with secukinumab 300 mg (2). However, according to current study observations, around 52% and 29% cases only achieved PASI 75 and PASI 90 at the same time interval. PASI 100 was attained after one month of administering nine doses in 58.8% cases. But one sixth (17%) of the study group showed relapse within three months.

Besides considering the benefits of secukinumab, its side effects cannot be deflected on a long run. The role of IL-17 in host defense against pathogens raised concerns about the risk of infections under IL-17 Inhibitors (IL-17I). Overall, IL-17Iand IL-17 receptor inhibitors boost an impressive safety profile despite an elevated risk of mucocutaneous candidiasis (20) and respiratory tract infections (21). It is contraindicated for use in Interstitial Bowel Disease (IBD) and HIV patients. The most common adverse effects of secukinumab include upper respiratory tract infections and headache. Others that should be closely monitored include infections, hypersensitivity reactions, neutropenia, and rare cases of new or worsening IBD. In our study group none of the patients reported any such side-effects. Psoriasis by itself is frequently associated with cardiometabolic co-morbidities, such as obesity and diabetes, that are risk factors leading to poor prognosis in the case of COVID-19 (22). The usage of biologicals may increase the susceptibility to COVID-19 infection due to its immunosuppressive action. However, considering that cytokine storm following COVID-19 infection is the leading cause of pulmonary inflammation and subsequent respiratory failure, targeting these cytokines by use of specific biological can be protective in COVID-19 pneumonia and death. In COVID-19 affected patients, a high Th17 cells activation could result from a virus-driven increased production of IL-6 by the immune system (23),(24). ARDS occurs in 81% of fatal cases of COVID-19. In ARDS, IL-17 augments the destruction of the lung parenchyma through maladaptive neutrophil recruitment, by stimulating the production of proinflammatory mediators and through the prevention of apoptosis (25),(26).

A study by Ekinci P et al., found that, despite living in the same house with a COVID-19 positive household, two patients who had been taking IL-17 inhibitor secukinumab did not develop suspicious symptoms of COVID-19 suggesting a possible protective effect of anti IL-17 agents (27). In this study, five patients who were on secukinumab maintenance dose, had family members with COVID-19 infection for which they were suggested home isolation. These five patients did not develop COVID-19 infection during and after secukinumab therapy despite living with COVID-19 infected relatives in the same household. A population-based study by Kridin K et al., in Israel which involved 680,2,153 and 138,750 patients treated with IL-17I, methotrexate, and nonsystemic/ non immunomodulatory drugs respectively, concluded that there was no increased risk of COVID-19 infection, among patients with psoriasis treated by IL-17I (28). Findings in this study were consistent with these studies as no patient on secukinumab developed symptoms of COVID-19 infection or tested positive for COVID-19 by RTPCR during the course of treatment for six months and a follow-up of three months.

National Psoriasis Foundation COVID-19 task force guidelines for management of Psoriasis during pandemic suggests that patients with psoriatic disease should receive the seasonal inactivated (eg, killed) influenza vaccine. While this vaccine will not protect against SARS-CoV-2, influenza vaccine lowers the risk of infection from seasonal influenza, which is of special importance to the individual and public health during the COVID-19 pandemic (29).

IL-17A inhibitor-secukinumab has been proven not to affect the humoral response to Influenza vaccination in patients of psoriatic arthritis (30). It has been reported that there is no contraindication for use of IL-17 inhibitors with Moderna (mRNA 1237 vaccine) and Pfizer BioNtech (BNT162b2) vaccines (31). According to current observation, it was found that secukinumab does not seem to affect seroconversion or modify the efficacy when used simultaneously with Covaxin and Covishield, since no patient developed COVID-19 infection following vaccination. To our best knowledge, this study was the first of its kind to report the safety of secukinumab with COVID-19 vaccines available in India. The availablity of various choices of safe and effective drugs help the treating practitioner handle these challenges and provide an improved quality of life, free of morbidities to the patient.

Limitation(s)

The main limitation of this study was a relatively small sample size and more number of drop outs (26% of the participants). This was an ambispective observational study without any comparison group. A larger multicentre study is needed to determine the optimal treatment with safety for psoriasis during life threatening pandemics like COVID-19.

Conclusion

It is obvious that injection secukinumab has a wide safety margin even during the pandemic times in that the patients who were initiated early on secukinumab before the advent of pandemic era are able to continue treatment with the drug. Vaccination of all types was not a contraindication for the continuation of secukinumab injection for treating psoriasis. The drug was found to have a smooth impact on the quality of life of patients even during the pandemic without warranting either deferring of vaccination or termination of treatment postvaccination. Thorough prebiological work-up, strict adherence to safety precautions during COVID-19 pandemic and following COVID-19 appropriate behavior will ensure 100% successful implementation of the therapeutic efficacy IL-17 inhibitor during COVID-19 pandemic.

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DOI and Others

DOI: 10.7860/JCDR/2023/59172.17381

Date of Submission: Jul 19, 2022
Date of Peer Review: Oct 18, 2022
Date of Acceptance: Nov 18, 2022
Date of Publishing: Jan 01, 2023

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. Yes

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jul 20, 2022
• Manual Googling: Nov 08, 2022
• iThenticate Software: Nov 17, 2022 (20%)

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