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Article ; Online: Tofacitinib as monotherapy in cutaneous polyarteritis nodosa: a case series.

Roy, Debaditya / Sathyanarayana, Vanitha Agrahara / Nagaraju, Bhavya / Rao, Vijay K R

Rheumatology advances in practice

2023 Volume 7, Issue 2, Page(s) rkad049

Abstract: Objective: Cutaneous polyarteritis nodosa (CPAN) is a distinct clinical entity represented by a chronic, relapsing, benign course, with rare systemic involvement. Treatment is with CSs, CYC or other conventional synthetic DMARDs (csDMARDs). In this case ...

Abstract	Objective: Cutaneous polyarteritis nodosa (CPAN) is a distinct clinical entity represented by a chronic, relapsing, benign course, with rare systemic involvement. Treatment is with CSs, CYC or other conventional synthetic DMARDs (csDMARDs). In this case series, we aimed to share our varied clinical experience of successfully treating patients with CPAN, with tofacitinib in a refractory/relapsing course or as upfront monotherapy without CSs/csDMARDs. Methods: We report this retrospective case series managed at our rheumatology centre in Bangalore from 2019 to 2022. Four patients identified as CPAN on biopsy were able to achieve disease-free remission with tofacitinib as part of their treatment, with no relapse on further follow-up. Our patients presented with subcutaneous nodules and cutaneous ulcers. After systemic evaluation, all the patients underwent skin biopsy, which showed fibrinoid necrosis in the vessel walls of the dermis, with a histopathological impression of CPAN. They were initially treated with a conventional approach of CSs with/without csDMARDs. On experiencing a refractory/relapsing course, tofacitinib was tried in all the patients as either CS sparing or upfront monotherapy without concomitant csDMARDs. Results: Use of tofacitinib resulted in improvement of ulcers and paraesthesia and in gradual healing of skin lesions, albeit with scarring, with no further recurrence or relapse over a follow-up period of 6 months for all the patients. The therapeutic effect of tofacitinib was consistent when used either as CS sparing or as upfront monotherapy, thereby proving the drug to be a promising option that warrants larger trials in future to treat the subset of patients with established CPAN. Conclusion: Tofacitinib could be used for disease-free remission as monotherapy for CPAN either upfront or as CS sparing, even without concomitant csDMARDs, in those patients who are dependent on CSs or multiple DMARDs.
Language	English
Publishing date	2023-06-09
Publishing country	England
Document type	Journal Article
ISSN	2514-1775
ISSN (online)	2514-1775
DOI	10.1093/rap/rkad049
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Article ; Online: Tofacitinib in pyoderma gangrenosum - A case series.

Sathyanarayana, Vanitha Agrahara / Roy, Debaditya / Nagaraju, Bhavya / Rao, Vijay K R

International journal of rheumatic diseases

2023 Volume 27, Issue 1, Page(s) e14810

Abstract: Pyoderma gangrenosum (PG) is a rare autoinflammatory disorder falling under the spectrum of neutrophilic dermatosis, characterized by distinctive skin ulceration which is non-infective, non-neoplastic and usually with no primary vasculitis. PG lesions ... ...

Abstract	Pyoderma gangrenosum (PG) is a rare autoinflammatory disorder falling under the spectrum of neutrophilic dermatosis, characterized by distinctive skin ulceration which is non-infective, non-neoplastic and usually with no primary vasculitis. PG lesions are notorious for relapse and hence require multiple trials of medications often with prolonged and concomitant use of steroids. Due to lack of evidence-based studies on effective treatment options for PG, we have presented three isolated biopsy-proven PG cases who were successfully treated with Tofacitinib, a Janus kinase/signal transducers and activators of transcription (JAK/STAT) pathway inhibitor, without relapse in follow up.
MeSH term(s)	Humans ; Pyoderma Gangrenosum/diagnosis ; Pyoderma Gangrenosum/drug therapy ; Pyoderma Gangrenosum/pathology ; Vasculitis ; Recurrence ; Piperidines ; Pyrimidines
Chemical Substances	tofacitinib (87LA6FU830) ; Piperidines ; Pyrimidines
Language	English
Publishing date	2023-07-03
Publishing country	England
Document type	Case Reports
ZDB-ID	2426924-4
ISSN	1756-185X ; 1756-1841
ISSN (online)	1756-185X
ISSN	1756-1841
DOI	10.1111/1756-185X.14810
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Article ; Online: Uncommon presentation of granulomatosis with polyangiitis: Prostate involvement.

Jain, Naman / Roy, Debaditya / Mysore, Satyanarayana / Negigowdru, Manjunath M / Rao, Vijay K R

International journal of rheumatic diseases

2023 Volume 27, Issue 1, Page(s) e14831

Abstract: Granulomatosis with polyangiitis (GPA) is an autoimmune granulomatous disease of unknown etiology; frequently associated with anti-proteinase 3 antineutrophil cytoplasmic antibody (PR3-ANCA). Although any organ can be involved, prostatic involvement in ... ...

Abstract	Granulomatosis with polyangiitis (GPA) is an autoimmune granulomatous disease of unknown etiology; frequently associated with anti-proteinase 3 antineutrophil cytoplasmic antibody (PR3-ANCA). Although any organ can be involved, prostatic involvement in GPA is very rare. We present a male patient with GPA, 26 years old, with pulmonary manifestations and prostatic involvement who underwent exhaustive evaluation. The patient's laboratory tests and imaging scans showed evidence of lesions in multiple areas, including the prostate. Histopathological testing confirmed that the lesions were consistent with granulomatosis with polyangiitis. The patient was treated with oral steroids and rituximab and showed significant improvement. He was later maintained on azathioprine without any relapse.
MeSH term(s)	Humans ; Male ; Adult ; Granulomatosis with Polyangiitis/complications ; Granulomatosis with Polyangiitis/diagnosis ; Granulomatosis with Polyangiitis/drug therapy ; Prostate/diagnostic imaging ; Prostate/pathology ; Rituximab/therapeutic use ; Myeloblastin ; Antibodies, Antineutrophil Cytoplasmic
Chemical Substances	Rituximab (4F4X42SYQ6) ; Myeloblastin (EC 3.4.21.76) ; Antibodies, Antineutrophil Cytoplasmic
Language	English
Publishing date	2023-07-09
Publishing country	England
Document type	Case Reports
ZDB-ID	2426924-4
ISSN	1756-185X ; 1756-1841
ISSN (online)	1756-185X
ISSN	1756-1841
DOI	10.1111/1756-185X.14831
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Article ; Online: Occurrence and outcome of COVID-19 in AIRD patients on concomitant treatment with Tofacitinib- results from KRA COVID COHORT (KRACC) subset.

Chebbi, Pramod / Shobha, Vineeta / Rao, Vijay K / Haridas, Vikram / Janardana, Ramya / Pinto, Benzeeta / Kumar, Sharath / Patil, Abhishek / Tekkatte, Roopa / Salanke, Manasa / Mahendranath, K M

BMC rheumatology

2023 Volume 7, Issue 1, Page(s) 22

Abstract: Introduction: We assessed the risk factors and outcome of COVID-19 in patients with autoimmune rheumatic diseases(AIRD) who contracted infection while on background treatment with tofacitinib.: Methods: This is a non-interventional, cross-sectional, ... ...

Abstract	Introduction: We assessed the risk factors and outcome of COVID-19 in patients with autoimmune rheumatic diseases(AIRD) who contracted infection while on background treatment with tofacitinib. Methods: This is a non-interventional, cross-sectional, questionnaire based telephonic study which included consecutive AIRD patients on tofacitinib co-treatment. Data related to the AIRD subset, disease modifying anti rheumatic drugs(DMARDs) including glucocorticoids and comorbidities, was collected from 7 rheumatology centers across Karnataka during the second wave of COVID-19 pandemic. The information about COVID-19 occurrence and COVID-19 vaccination was recorded. Results: During the study period (Jun-July 2021), 335 AIRD patients (80.6% female) on treatment with tofacitinib were included. The mean duration of tofacitinib use was 3.4+/-3.1months. Thirty-six(10.75%) patients developed COVID-19. Diabetes mellitus (p = 0.04 (OR 2.60 (1.13-5.99)) was identified as a risk factor for COVID-19 in our cohort. Almost half of our cohort was COVID-19 vaccinated with at least one dose, with resultant decline in incidence of COVID-19(OR 0.15 (0.06-0.39) among the vaccinated. Recovery amongst COVID-19 infection group was 91.2%. Conclusions: The subset of AIRD patients who were on treatment with tofacitinib were found to have a higher rate of COVID-19 infection as compared to our KRACC cohort. Pre-existing comorbidity of diabetes mellitus was the significant risk factor in our cohort. This subset of the KRACC cohort shows RA patients had a lesser infection and PsA patients had a higher infection.
Language	English
Publishing date	2023-07-26
Publishing country	England
Document type	Journal Article
ZDB-ID	2918121-5
ISSN	2520-1026 ; 2520-1026
ISSN (online)	2520-1026
ISSN	2520-1026
DOI	10.1186/s41927-023-00345-8
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Article ; Online: Real-life Tolerability and Effectiveness of Adalimumab Biosimilar in Ankylosing Spondylitis: the Adalimumab Biosimilar Patient Registry Data.

Kapoor, Sanjiv / Kaushik, Viswanath V / Jain, Rahul / Rao, Vijay K R / Gharia, Mihir

ACR open rheumatology

2019 Volume 1, Issue 8, Page(s) 480–484

Abstract: Objective: Adalimumab is a well-established anti-tumor necrosis factor therapy for patients with ankylosing spondylitis (AS). An indigenously developed biosimilar adalimumab (bADA) (ZRC-3197; Exemptia) is approved for prescribing in India. In this ... ...

Abstract	Objective: Adalimumab is a well-established anti-tumor necrosis factor therapy for patients with ankylosing spondylitis (AS). An indigenously developed biosimilar adalimumab (bADA) (ZRC-3197; Exemptia) is approved for prescribing in India. In this article, we present the effectiveness and tolerability of this bADA in real-life Indian patients with AS from the Adalimumab Biosimilar Patient Registry (ASPIRE) (ISRCTN: 16838474). Methods: ASPIRE is a postmarketing observational registry for evaluating the real-world experiences of patients with autoimmune inflammatory disorders across multiple centers in India who were prescribed 40 mg of Exemptia subcutaneously every fortnight. For this report, data available until 24 weeks of bADA treatment for patients with AS who were included in the registry were evaluated. Results: Data from 308 patients with AS from the registry (median age of 35.0 [range 17-68] years, 19% women) were analyzed. In analyzable patients with complete data, there was a gradual and significant decrease ( Conclusion: This report demonstrates the tolerability and effectiveness of bADA (Exemptia) after its clinical use for 24 weeks in real-world patients with AS from Indian clinical practice.
Language	English
Publishing date	2019-08-12
Publishing country	United States
Document type	Journal Article
ISSN	2578-5745
ISSN (online)	2578-5745
DOI	10.1002/acr2.11067
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Article ; Online: Risk factors associated with COVID-19 in systemic lupus erythematosus: Results from a longitudinal prospective cohort.

Lupus

2023 Volume 32, Issue 4, Page(s) 560–564

Abstract: Introduction: Patients with SLE (systemic lupus erythematosus) have a higher risk of infection due to dysregulated immune system as well as long-term use of immunosuppressants (IS). This could influence the risk of COVID-19 and its outcome.: Methods: ...

Abstract	Introduction: Patients with SLE (systemic lupus erythematosus) have a higher risk of infection due to dysregulated immune system as well as long-term use of immunosuppressants (IS). This could influence the risk of COVID-19 and its outcome. Methods: We conducted a longitudinal prospective study across 15 rheumatology centres during the first wave of the pandemic to understand the risk factors contributing to COVID-19 in SLE patients. During the 6 months follow-up, those who tested positive for COVID-19, their clinical course and outcome information were recorded. Results: Through the study period (April-December 2020), 36/1379 lupus patients (2.9%) developed COVID-19. On analysing the COVID-19 positive versus negative cohort during the study period, male gender (adjusted RR 3.72, 95% C.I. 1.85,7.51) and diabetes (adjusted RR 2.94, 95% C.I. 1.28, 6.79) emerged as the strongest risk factors for COVID-19, in the adjusted analysis. There was no significant influence of organ involvement, hydroxychloroquine, glucocorticoid dosage (prednisolone< 7.5 mg or ≥ 7.5 mg/day) or IS on the risk of COVID-19. There was only one death (1/36) among the lupus patients due to COVID-19. Conclusion: Traditional risk factors rather than lupus disease process or IS influenced the risk of COVID-19 in our cohort.
MeSH term(s)	Humans ; Male ; Lupus Erythematosus, Systemic/complications ; Lupus Erythematosus, Systemic/drug therapy ; Prospective Studies ; COVID-19/complications ; Longitudinal Studies ; Immunosuppressive Agents/adverse effects ; Risk Factors
Chemical Substances	Immunosuppressive Agents
Language	English
Publishing date	2023-02-02
Publishing country	England
Document type	Journal Article
ZDB-ID	1154407-7
ISSN	1477-0962 ; 0961-2033
ISSN (online)	1477-0962
ISSN	0961-2033
DOI	10.1177/09612033231155837
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Article ; Online: Hydroxychloroquine-related retinal toxicity.

Ding, Hui Jen / Denniston, Alastair K / Rao, Vijay K / Gordon, Caroline

Rheumatology (Oxford, England)

2015 Volume 55, Issue 6, Page(s) 957–967

Abstract: HCQ is widely used for the treatment of rheumatic diseases, particularly lupus and RA. It is generally well tolerated, but retinopathy is a concern. Retinopathy is rare, but is sight threatening, generally irreversible and may progress even after ... ...

Abstract	HCQ is widely used for the treatment of rheumatic diseases, particularly lupus and RA. It is generally well tolerated, but retinopathy is a concern. Retinopathy is rare, but is sight threatening, generally irreversible and may progress even after cessation of therapy. Damage may be subclinical. Although a number of risk factors have been proposed (such as duration of therapy and cumulative dose), the many exceptions (e.g. retinopathy on low-dose HCQ, or no retinopathy after a very large cumulative dose of HCQ) highlight our limited understanding of the disease process. Novel technologies such as optical coherence tomography (OCT), fundus autofluorescence (FAF) and multifocal electroretinogram (mfERG) may provide the earliest structural and functional evidence of toxicity in these stages. Along with the well-established technique of central visual field testing (10-2 visual fields), these modalities are increasingly being used as part of screening programmes. The ideal single test with high sensitivity and high specificity for HCQ retinopathy has still not been achieved. Screening for HCQ retinopathy remains an area of considerable debate, including issues of when, who and how to screen. Commonly accepted risk factors include receiving >6.5 mg/kg/day or a cumulative dose of >1000 g of HCQ, being on treatment for >5 years, having renal or liver dysfunction, having pre-existing retinopathy and being elderly. HCQ continues to be a valuable drug in treating rheumatic disease, but clinicians need to be aware of the associated risks and to have arrangements in place that would enable early detection of toxicity.
MeSH term(s)	Antirheumatic Agents/adverse effects ; Humans ; Hydroxychloroquine/adverse effects ; Optical Imaging ; Retinal Diseases/chemically induced ; Retinal Diseases/diagnostic imaging ; Rheumatic Diseases/drug therapy ; Risk Factors ; Tomography, Optical Coherence
Chemical Substances	Antirheumatic Agents ; Hydroxychloroquine (4QWG6N8QKH)
Language	English
Publishing date	2015-10-01
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/kev357
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Article ; Online: Maternal and fetal outcomes of lupus pregnancies: A collective effort by Karnataka Rheumatologists.

Janardana, Ramya / Haridas, Vikram / Priya, Vishnu / Bhat, Vasudha / Singh, Yogesh / Rao, Vijay K / Jois, Ramesh / Srikantiah, Chandrashekara / Pinto, Benzeeta / Shobha, Vineeta

Lupus

2020 Volume 29, Issue 11, Page(s) 1397–1403

Abstract: Introduction: Identifying factors predicting adverse pregnancy outcomes involving systemic lupus erythematosus (SLE) is a research priority. The aims of this study were to investigate (a) the maternal and fetal outcomes of pregnant lupus patients and ... ...

Abstract	Introduction: Identifying factors predicting adverse pregnancy outcomes involving systemic lupus erythematosus (SLE) is a research priority. The aims of this study were to investigate (a) the maternal and fetal outcomes of pregnant lupus patients and the factors associated with adverse pregnancy outcomes, and (b) the effect of pregnancy on lupus disease activity of these patients. Methods: This was an ambi-directional study collecting information from five multi-specialist referral centres across the state of Karnataka, India over 5 years (2013-2018). Clinical details of pregnancies and outcomes that were temporally associated with lupus disease were recorded using a structured pro forma. The Safety of Estrogen in SLE National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) was used to assess lupus activity during the 6 months prior to pregnancy and the intra- and post-partum periods. Modifications suggested in the SLE Pregnancy Disease Activity Index were considered while scoring. Results: A total of 121 pregnancies in 80 SLE patients with a mean age of 27.1 (±4.5) years and with a mean disease duration of 4.6 (±4.1) years were reviewed. Largely patients were in clinical remission (109/121; 90.1%). Antiphospholipid antibody positivity was seen in 45/121 (37.2%) patients. A history of lupus nephritis was noted in 29/121 (24%) patients. Maternal complications (32%) were mainly due to hypertensive disorders of pregnancy (HDP; 19/121; 15.7%). Adverse fetal outcomes (58%) were mainly in the form of spontaneous first-trimester abortions (21/121; 16%), stillbirth (14/121; 11.6%) and prematurity (24/121; 20%). HDP is strongly associated with stillbirth and prematurity and is independent of active lupus. Disease activity was associated with a three-fold increased risk of adverse fetal outcome in univariate analysis. The risk of major flare during pregnancy is low (4.1%) when conception occurs during stable disease. Hydroxychloroquine (HCQ) use was associated with reduced risk of flare ( Conclusions: The risk of major flare during pregnancy is low when conception happens during stable disease. HCQ use was associated with reduced risk of flare in patients in remission at the time of conception. HDP was strongly associated with stillbirth and prematurity and are independent of active lupus in our cohort.
MeSH term(s)	Abortion, Spontaneous/epidemiology ; Adult ; Female ; Humans ; Hydroxychloroquine/therapeutic use ; India/epidemiology ; Infant, Newborn ; Lupus Erythematosus, Systemic/complications ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Nephritis/complications ; Pre-Eclampsia/diagnosis ; Pre-Eclampsia/etiology ; Pregnancy ; Pregnancy Complications/diagnosis ; Pregnancy Complications/etiology ; Pregnancy Outcome/epidemiology ; Premature Birth/epidemiology ; Remission Induction ; Severity of Illness Index ; Young Adult
Chemical Substances	Hydroxychloroquine (4QWG6N8QKH)
Language	English
Publishing date	2020-08-02
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	1154407-7
ISSN	1477-0962 ; 0961-2033
ISSN (online)	1477-0962
ISSN	0961-2033
DOI	10.1177/0961203320944503
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Article ; Online: A prospective longitudinal study evaluating the influence of immunosuppressives and other factors on COVID-19 in autoimmune rheumatic diseases.

BMC rheumatology

2022 Volume 6, Issue 1, Page(s) 32

Abstract: Background: We conducted this study to identify the influence of prolonged use of hydroxychloroquine (HCQ), glucocorticoids and other immunosuppressants (IS) on occurrence and outcome of COVID-19 in patients with autoimmune rheumatic diseases (AIRDs).!## ...

Abstract	Background: We conducted this study to identify the influence of prolonged use of hydroxychloroquine (HCQ), glucocorticoids and other immunosuppressants (IS) on occurrence and outcome of COVID-19 in patients with autoimmune rheumatic diseases (AIRDs). Methods: This was a prospective, multicenter, non-interventional longitudinal study across 15 specialist rheumatology centers. Consecutive AIRD patients on treatment with immunosuppressants were recruited and followed up longitudinally to assess parameters contributing to development of COVID-19 and its outcome. Results: COVID-19 occurred in 314 (3.45%) of 9212 AIRD patients during a median follow up of 177 (IQR 129, 219) days. Long term HCQ use had no major impact on the occurrence or the outcome of COVID-19. Glucocorticoids in moderate dose (7.5-20 mg/day) conferred higher risk (RR = 1.72) of infection. Among the IS, Mycophenolate mofetil (MMF), Cyclophosphamide (CYC) and Rituximab (RTX) use was higher in patients with COVID 19. However, the conventional risk factors such as male sex (RR = 1.51), coexistent diabetes mellitus (RR = 1.64), pre-existing lung disease (RR = 2.01) and smoking (RR = 3.32) were the major contributing risk factors for COVID-19. Thirteen patients (4.14%) died, the strongest risk factor being pre-existing lung disease (RR = 6.36, p = 0.01). Incidence (17.5 vs 5.3 per 1 lakh (Karnataka) and 25.3 vs 7.9 per 1 lakh (Kerala)) and case fatality (4.1% vs 1.3% (Karnataka) and 4.3% vs 0.4% (Kerala)) rate of COVID-19 was significantly higher (p < 0.001) compared to the general population of the corresponding geographic region. Conclusions: Immunosuppressants have a differential impact on the risk of COVID-19 occurrence in AIRD patients. Older age, males, smokers, hypertensive, diabetic and underlying lung disease contributed to higher risk. The incidence rate and the case fatality rate in AIRD patients is much higher than that in the general population.
Language	English
Publishing date	2022-06-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2918121-5
ISSN	2520-1026 ; 2520-1026
ISSN (online)	2520-1026
ISSN	2520-1026
DOI	10.1186/s41927-022-00264-0
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