POS1034 EFFICACY AND SAFETY OF ADD-ON GENERIC TOFACITINIB EXTENDED RELEASE IN MODERATE TO SEVERE RHEUMATOID ARTHRITIS PATIENTS HAVING INADEQUATE RESPONSE TO DISEASE-MODIFYING ANTIRHEUMATOID DRUGS: REAL-WORLD STUDY FROM EASTERN PART OF INDIA

B. Choudhuri

doi:10.1136/annrheumdis-2024-eular.2152

Abstract

Background: Despite approval of Tofacitinib extended-release (XR) 11 mg tablets, there is scarcity of real-world patients’ efficacy and safety data in Indian population with rheumatoid arthritis. Study is conducted to strengthen the limited data in real-world population – first such study from Eastern part of India.

Objectives: To assess the efficacy and safety of generic Tofacitinib XR 11 mg once daily with csDMARDs as add-on treatment in patients with moderate to severe rheumatoid arthritis (RA).

Methods: In this study patients of moderate to severe RA, having inadequate response to either csDMARDs or biologic DMARDs, received generic Tofacitinib XR 11 mg once daily along with csDMARDs. The Primary endpoint was the response rate according to the Disease Activity Score-28 CRP for Rheumatoid Arthritis (DAS28-CRP) & American College of Rheumatology 20%, 50% & 70% improvement criteria (ACR20, ACR50 & ACR70) at week 12.

Results: Out of total 60 patients, they were predominantly female (58.33%) with mean age of 50.3±12.8 years. Mean BMI of patients was 26.83±4.92 kg/cm² suggesting overweight. Majority of patients were Sero-positive RA (76.66%) with 38.33% patients having positive family history of auto-immune conditions. Mean duration of disease was 7.28 years (6 months-25 years). 26.6% of patients were having Hypertension, followed by Diabetes Mellitus 23.66% & 6.66% had Hypothyroidism and Sjogren’s disease as comorbid conditions, which were controlled with medications. Among the patients, previously 20% were on bDMARDs and 80% of patients were on only csDMARDs. All patients subsequently were prescribed generic Tofacitinib XR 11 mg as add-on management along with Methotrexate, Leflunomide, Hydroxychloroquine and Sulfasalazine in 41.66%, 26.66%, 23.33% and 8.33% patients respectively. At baseline, mean DAS28-CRP was 6.33; after 12 weeks of treatment with Tofacitinib DAS28-CRP dropped to 2.77. The change (-3.56) was statistically significant (p <.00001) [Chart 1]. ACR20 response rate was achieved in 34 patients (56.66%), ACR50 in 18 patients (30%) and ACR70 response rate was observed in 8 patients (13.33%) at week 12 of Tofacitinib add on treatment with csDMARDs [Chart 2]. Minor adverse events were observed in 18.33% of patients which did not require discontinuation of treatment and resolved without any intervention, including UTI (8.33%), Pharyngitis (5%), Acute Gastroenteritis (3.33%), LRTI (3.33%). However, severe adverse events were observed in 2 patients (3.33%) which required temporary discontinuation of Tofacitinib. 1 patient had activation of Pulmonary Tuberculosis and other patient reported to have Herpes Zoster infection which required a short hospitalization for conservative management.

Conclusion: In this real-world analysis of adding generic Tofacitinib XR 11 mg to csDMARDs demonstrated effectiveness in achieving statistically significant functional improvement in patients having inadequate response to csDMARDs or biologic DMARDs. Safety profile was consistent with that reported from other reported studies.

REFERENCES: [1] Cohen SB, Pope J, Haraoui B, Mysler E, Diehl A, Lukic T, Liu S, Stockert L, Germino R, Menon S, Shi H, Keystone EC. Efficacy and safety of tofacitinib modified-release 11 mg once daily plus methotrexate in adult patients with rheumatoid arthritis: 24-week open-label phase results from a phase 3b/4 methotrexate withdrawal non-inferiority study (ORAL Shift). RMD Open. 2021 Jun;7(2):e001673. doi: 10.1136/rmdopen-2021-001673

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