Rituximab has a myriad of clinical uses, ranging from its disease modifying action in rheumatoid arthritis, to its role in chemotherapy for cancer. Being an anti CD20 monoclonal antibody, it controls inflammation by targeting peripheral B cells including those present in the synovium. The use of Rituximab is associated with some side effects such as cytopenias and increased risk of infections such as JC virus reactivation leading to multifocal encephalopathy. The role of Rituximab as an immunosuppressant has been established. However, its association with tuberculosis in endemic countries like India is yet to be understood well. The study was a cross sectional study of the two cases reported about the incidence of tuberculosis in patients receiving infusions of rituximab for rheumatoid diseases. These adverse drug reactions were reported to the nearest pharmacovigilance center through the Vigiflow portal of WHO and were assessed for their causality as per the WHO scale. A 45 year old male patient, a known case of Systemic Lupus Erythematosus, presented to a tertiary care hospital with high grade fever with chills and rigors after which he was diagnosed with pleural effusion due to tuberculosis. The patient was on immunosuppressants which included Rituximab, Mycophenolate Sodium, Prednisolone and Hydroxychloroquine. Rituximab was withdrawn and the remaining medications were continued as per the initial plan. A 19 year old male patient, a known case of dermatomyositis and dilated cardiomyopathy, presented to a tertiary care hospital with complaints of fever with chills and rigors, and breathlessness on exertion which was followed by the diagnosis of miliary tuberculosis. Earlier, the patient was on Rituximab, Cyclophosphamide, Hydroxychloroquine and Prednisolone. Plan of further infusions of Rituximab and Cyclophosphamide was terminated while the remaining medications were continued. Both the patients were put on anti tubercular therapy and are now improving. The association of bacterial infections like tuberculosis with the use of Rituximab is not well understood. However, Rituximab being an immunosuppressant can be considered to be related to this infection. In our case series we readdress this association through a literature review.
Adalimumab is a disease-modifying antirheumatic drug and monoclonal antibody that works by antagonising tumour necrosis factor-alpha prescribed in many rheumatological conditions like Rheumatic arthritis, Ankylosing spondylitis and Behcet’s disease. Serious side effects with this drug include heart and liver failure, nervous and blood disorders, allergic and immune system reactions and opportunistic infections. A 27-year-old female patient, known case of Behcet’s disease presented to the hospital with complaints of fever, cough and breathlessness following administration of Adalimumab, six doses over three months. Chest X-ray and BAL-CBNAAT was suggestive of Tuberculosis. AKT was started and Adalimumab was suspended until patient recover.
Background/Aims While BASDAI is one of the most widely used tool it has limited face and construct validity. ASDAS on the other hand is considered more objective ,however in absence of blood investigations, it might not be an ideal measure. We aimed to study correlation and agreement between ASDAS-CRP with BASDAI score. We correlated these outcome measures with MRI activity Methods This was a multi-centre study, conducted at rheumatology department of two teaching hospitals in United Kingdom and India. Anonymised data of all consecutive patients with the clinical diagnosis of SpA were analysed. We compared outcome measure variables ASDAS-CRP with BASDAI at baseline and follow-up with subgroup analysis of BASDAI cutoff of 4. We also analysed radiological parameters and compared disease activity of patients with active changes of SpA in MRI versus those with inactive changes . SPSS software and Cohen’s kappa statistics used Results Total 250 patients with SpA were analysed with median age of 34 years and total duration of 5.9 +6 years. Mean BASDAI 4.9 +8.8, Mean ASDAS-CRP 3.04 + 3.5, Mean CRP 19.32 +12.8 mg/l. The Correlation between BASDAI and ASDAS-CRP (r) was 0.76 and the correlation coefficient of agreement between ASDAS-CRP and BASDAI >4 was 0.75.The cutoff point of ASDAS with the best agreement with BASDAI was 3.5 (global agreement 78%, kappa 0.55). Both BASDAI and ASDAS showed a higher correlation with patient’s global assessment (PtGA) (r = 0.82 and 0.74, respectively) than with physician’s global assessment(PhyGA) (r = 0.76 and 0.7) The discriminant validity analysis showed that both ASDAS and BASDAI were able to discriminate patients above and below median PtGA (d = 1.15 &d=1.3) and PhyGA (d = 0.75 and d = 0.9) respectively however BASDAI was better than ASDAS to discriminate patients above and below the median PhyGA (p = 0.05)60 patients were followed up with mean duration of follow-up of 6.2 +1.6 months. Both ASDAS and BASDAI decrease significantly (p = 0.03 and 0.02 respectively) however effect size was greater for ASDAS(0.8) than BASDAI (0.6). There was no difference noted in the degree of spinal inflammation as evidenced by MRI when patients with BASDAI >4 were compared to < 4. (p = 0.43, OR 0.6). The correlation between ASDAS and BASDAI was much higher in patients with active MRI lesions (r = 0.84), without any difference in CRP or BASDAI (p = 0.8 and p = 0.66 respectively) Conclusion This is a first study involving India and UK, which systematically compares the disease activity and outcome measures. Although BASDAI and ASDAS correlate well, the agreement is better for patients with high disease activity. ASDAS is more sensitive to change and shows larger effect size on follow-up. The outcome measures correlated more with active MRI lesions. Thus the cutoff value of BASDAI >4 for active disease might need a revision in clinical practice Disclosure N. Jain: None. S. Pandya: None. P. Srivastava: None. D. Shukla: None. A. Moorthy: Honoraria; Speaker and Conference fee MSD, Novartis Abbvie.
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