Handbook of Biologics for Rheumatological Disorders

286 Pages·2022·4.559 MB·English

by  Neeraj Jain (editor), Lalit Duggal (editor)

Handbook of Biologics
for Rheumatological
Disorders
Neeraj Jain
Lalit Duggal
Editors
123
Handbook of Biologics for Rheumatological
Disorders
Neeraj Jain • Lalit Duggal
Editors
Handbook of Biologics
for Rheumatological
Disorders
Editors
Neeraj Jain Lalit Duggal
Sir Ganga Ram Hospital Sir Ganga Ram Hospital
New Delhi, India New Delhi, India
ISBN 978-981-16-7199-9 ISBN 978-981-16-7200-2 (eBook)
https://doi.org/10.1007/978-981-16-7200-2
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Preface
It was sheer serendipity, while going through recent chapters and books on rheuma-
tology, written and edited by our brethren, that we decided to embark on this project.
The purpose was to bring out something different, handy, and useful for the
beginners as well as for the experienced, in one of the most exciting and happening
aspects in rheumatological disorders—the BIOLOGICS.  The aforementioned
agents have virtually transformed the entire spectrum of approach in managing
these often difficult to treat conditions.
From the discovery of MABs (monoclonal antibodies) in 1975, it took about two
and a half decades for the approval of the first molecule in rheumatoid arthritis. In
the last 10 years or so, there has been an avalanche of sorts of these agents in various
fields of rheumatology. The latest kid on the block, the JAK inhibitors, the so-called
oral biologics, have been added to the armamentarium.
This treatise is a novel attempt to portray the utility of “on the shelf and in the
pipeline” biologics, in common rheumatological diseases. It includes a fascinating
introduction to their history, along with a bird’s-eye view of their use in the presence
of infections, malignancies, their ethical aspects, their off-label use, and the bio-
similars, the latter being so very cost relevant in our context. The chapters on bio-
logics in pediatric rheumatologic disorders as well as in osteoarthritis and
osteoporosis add value to this book. And finally their usefulness in conditions as
varied and diverse as uveitis, sarcoidosis, and the nascent IgG4-related disease will,
in all likelihood, complete the major groups where these drugs may be of importance.
It is not to project the biologics as the “be-all and end-all” of treatment in rheumatol-
ogy. It is a known fact that rheumatologists have to tread very carefully in their use.
And except for spondyloarthritis, ANCA-associated vasculitis, and perhaps a few other
conditions, their upfront use is not projected and approved at this moment of time.
Contributions from the plethora of pan-India talent, along with a sprinkling of
international flavor of erudite scholars, while adding value to this book, will further
enrich the knowledge of the readers.
We hope, this one of a kind work, with a virtual catalogue of biologics, is of help
to all those looking for a quick reference regarding the practicability of these “won-
der drugs” in the field of rheumatology.
New Delhi, India Neeraj Jain
Lalit Duggal
v
Contents
1 A Historical Introduction to the Biological Response
Modifier Drugs: The ‘Biologicals’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Anand N. Malaviya
2 Biologics in Rheumatoid Arthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Rohini Handa
3 Biologics in Spondyloarthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Bimlesh Dhar Pandey
4 Biologics in Psoriatic Arthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Rahul Sahu, Arvind Ganapati, and Ashish Jacob Mathew
5 Biologics in Gout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Abhishek
6 Biologics in Systemic Lupus Erythematosus (SLE) . . . . . . . . . . . . . . . . 61
Chi Chiu Mok
7 Biologics in Sjogren’s Syndrome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Elizabeth Price
8 Biologics in Systemic Sclerosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
David Roofeh, Alain Lescoat, and Dinesh Khanna
9 Biologics in Idiopathic Inflammatory Myopathies . . . . . . . . . . . . . . . . 101
Rudra Prosad Goswami and Uma Kumar
10 Biologics in ANCA-Associated Vasculitides . . . . . . . . . . . . . . . . . . . . . . 113
Saket Jha and Aman Sharma
11 Biologics in Behcet’s syndrome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Rudrarpan Chatterjee, Sundeep Grover, and Vikas Agarwal
12 Biologics in Takayasu’s Arteritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Avanish Jha and Debashish Danda
vii
viii Contents
13 Biologics in Interstitial Lung Diseases
in Rheumatological Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Ashish Sharma and Ashok Kumar
14 Biologics in Osteoporosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Ira Pande
15 Biologics in Osteoarthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Siddharth Kumar Das
16 Biologics in Juvenile Idiopathic Arthritis . . . . . . . . . . . . . . . . . . . . . . . . 165
Mehul P. Jariwala and Sujata Sawhney
17 Biologics in Pediatric Connective Tissue Disorders . . . . . . . . . . . . . . . . 179
Sarit Sekhar Pattanaik and Amita Aggarwal
18 JAK Inhibitors in Rheumatic Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
P. D. Rath, S. S. Nelson, and A. K. Khan
19 Biologics in Rheumatic Diseases in the Presence of Infection . . . . . . . . 199
Padmanabha Shenoy and Kaveri K. Nalianda
20 Biologics in Rheumatologic Conditions with Malignancy . . . . . . . . . . . 213
Lata Bichile, Dipti Patel, and Tanmayee Bichile
21 Biologics in Uveitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Sirichai Pasadhika and James T. Rosenbaum
22 Biologics in Sarcoidosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
Ved Chaturvedi and Mayank Gupta
23 Biologics in IgG4-Related Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Amit Dua, Neeraj Jain, Lalit Duggal, and Bhavya Chintala
24 Biosimilars in Rheumatology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
Mohit Goyal and Vinod Ravindran
25 Off-Label Use of Biologics in Rheumatological Disorders . . . . . . . . . . 261
Sumantro Mondal and Alakendu Ghosh
26 Biologics and Ethical Issues in Rheumatology . . . . . . . . . . . . . . . . . . . . 273
Nibha Jain, Dhaiwat Shukla, Prashant Chotalia,
and Sapan C. Pandya
27 Patient Consent for Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283
S. J. Gupta
About the Editors
Neeraj Jain is vice-chairman at the Rheumatology and

Clinical Immunology Department at Sir Ganga Ram
Hospital, New Delhi, India. He is a Professor of
GRIPMER, an academic body of Sir Ganga Ram
Hospital.
He did his rheumatology training at King Edward
Memorial Hospital, Mumbai, India, and Royal National
Hospital for Rheumatic Diseases, Bath, UK.
He is a fellow of the Royal College of Physicians of
Edinburgh (FRCP), UK, and the American College of
Rheumatology (FACR).
He is faculty in the Rheumatology and Clinical
Immunology Department at Sir Ganga Ram Hospital,
established in 2009.
Dr. Neeraj has more than 30 publications to his
credit in both national and international journals. He
has contributed several chapters to various books and
has peer-reviewed articles in many international rheu-
matology journals.
He is an active member of the Indian Rheumatology
Association (IRA) and Delhi Rheumatology
Association. He is a member of the Delhi Rheumatology
and Immunology Foundation (DRIF).
ix
x About the Editors
Lalit Duggal is Chairman, Department of Rheuma-

tology and Clinical Immunology at Sir Ganga Ram
Hospital, New Delhi, India.
He is a graduate of Armed Forces Medical College
Pune and Medicine post-graduate from King George’s
Medical College Lucknow. He has received
Rheumatology training in the USA.
In 2003 he was conferred the fellowship of the Royal
College of physicians of Glasgow, and he continues to
be actively associated with it as an examiner.
Dr. Duggal has been a temporary advisor to the
WHO in 1999.
He has been an active rheumatologist for close to
three decades. He is credited with establishing the
department of Rheumatology and Clinical immunology
at Sir Ganga Ram Hospital in 2009. He was instrumen-
tal in initiating the DNB programme in the hospital in
2013 and he also supervises rheumatology fellowship
courses in the institution.
Dr. Duggal has more than 50 publications to his
credit in both national and international journals includ-
ing original work in ankle arthritis with mediastinal
lymphadenopathy and IgG4-related disease. He has
chapters in various rheumatology books and has peer-
reviewed articles in international rheumatology
journals.
He is an active member and past president of the
Delhi Rheumatology Association. He is the founder and
president of Delhi Rheumatology and Immunology
Foundation (DRIF). This foundation is involved in vari-
ous social activities including patient and physician
education, especially on important dates, such as World
arthritis and World lupus days.
A Historical Introduction 1
to the Biological Response Modifier
Drugs: The ‘Biologicals’
Anand N. Malaviya
1.1 Introduction
The real impact of biological drugs in the practice of medicine can hardly be appre-
ciated by today’s over-busy young physicians trying to keep up with the increasing
workload, spending late hours in the corridors of big-city hospitals. They would not
have time to stop to think about how and who was involved in the discovery of
‘mabs’ and ‘cepts’, (the biological drugs) that are now available for a wide spectrum
of diseases across specialities. These physicians would be least interested in the his-
tory of the discovery of these drugs that are nothing short of ‘miracles’ if there ever
was one. Yet the story of the discovery of the biologicals is like a highly engrossing
novel with excitements, despair, thrills and ecstasy with an intense ending.
The present-day science is unlike that of the yesteryears. In those good old days,
one brilliant mind would get a heavenly inspiration and suddenly discover ‘Gravity’
(Sir Isac Newton’s discovery of gravity), the so-called ‘Eureka moment’—a moment
of sudden, triumphant discovery, inspiration or insight. The scientific discoveries of
modern times are very different and mundane. It usually builds upon a solid founda-
tion of knowledge and newer technologies developed over decades of work involv-
ing large teams of scientists in huge laboratories, often with coordination among
different centres around the world. The discovery of biologicals has not been
A. N. Malaviya (*)
Head of the Department of Rheumatology, ISIC Superspeciality Hospital, New Delhi, India
© The Author(s), under exclusive license to Springer Nature Singapore 1
Pte Ltd. 2022
N. Jain, L. Duggal (eds.), Handbook of Biologics for Rheumatological Disorders,
https://doi.org/10.1007/978-981-16-7200-2_1