|LETTER TO EDITOR
|Year : 2022 | Volume
| Issue : 2 | Page : 192
The perils of generic small molecules: Has tofacitinib become a toffee
Kunal Chandwar, Prasanna Dogga, Juhi Dixit, Digvijay Gajanan Ekbote, Kriti Kishor
Department of Clinical Immunology and Rheumatology, King George's Medical University, Lucknow, Uttar Pradesh, India
|Date of Submission||06-Sep-2021|
|Date of Acceptance||23-Sep-2021|
|Date of Web Publication||22-Jan-2022|
Dr. Kunal Chandwar
Department of Clinical Immunology and Rheumatology, King George's Medical University, Lucknow - 226 003, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Chandwar K, Dogga P, Dixit J, Ekbote DG, Kishor K. The perils of generic small molecules: Has tofacitinib become a toffee. Indian J Rheumatol 2022;17:192
Tofacitinib (Xeljanz) the new wonder kid on the block is certainly turning out to be the JAK of all trades. From rheumatoid arthritis to COVID, there seems no autoimmune inflammatory rheumatic disease (AIRD) the drug cannot conquer. They are like the new age steroids – work everywhere with quick relief. Approved indications include rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular JIA. Encouraging data have also been published in dermatomyositis, calcinosis, takayasu, axial spondylarthritis, SLE, Sjogren's, and ANCA-associated vasculitis.
It's been almost a year since the generic tofacitinib has come to the fore with as many as 10 pharmaceutical companies flooding the market. Tofacitinib has not only become cheap and accessible but also has brought respite to those uncontrolled on first-line or second-line therapies and not affording biologics.
With an oral route of administration, faster onset of action and greater pain alleviation JAK inhibitors offer a lucrative option over other agents including biologics which are often believed to be difficult to prescribe, expensive, and potentially dangerous drugs. With affordable cost and a pharma push, these have come to the forefront of most anti-rheumatic therapies while there's some truth in this the disadvantages and risks are never clearly spelt out and the drug is often prescribed unnecessarily, unethically, and improperly. However, with great power comes great responsibility, ease of availability and affordability has put the necessary caution required while prescribing a drug into backseat.
The authors have seen tofacitinib being prescribed by practitioners of alternative and Modern medicine being used even in noninflammatory arthritis. There have been similar experiences where tofacitinib was used as a first-line agent for the treatment of AIRDs.
There was no pre-JAK inhibitor screening done for most patients and no postdrug monitoring in many of the patients who were prescribed JAK inhibitors from outside.
Shared decision-making as a practice in India between physician and patient is neither as prevalent nor perfect as in the western world. Most patients put the onus of deciding the best therapy on the shoulders of the physicians (doctor, you tell us what's best for the patient) despite explaining to them the pros and cons of available therapy.
We as a community of rheumatologists need to come up with guidelines for usage of Tofacitinib and Baricitinib (with Generics coming for baricitnib too). A uniform screening and monitoring advisory, pretherapy vaccination guidelines, and posttherapy precautions both for short term (as in SARS-CoV Pneumonia) and long-term usage. Furthermore, an evidence-based advisory of the correct place of JAK inhibitors in AIRD should be clearly specified. With the FDA putting a black box warning on JAK inhibitors regarding increased of serious heart-related events such as heart attack or stroke, cancer (especially lymphoma), blood clots, and death proper regulation has become need of the hour. At the same time, we need to sensitize the government and policy-makers about regulating who can prescribe these drugs for what indications and increase the awareness among our patients. Tofacitinib is truly a boon for many but can easily turn into a curse in wrong hands.
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Conflicts of interest
There are no conflicts of interest.