Safety and effectiveness of intravenous CT-P13 in inflammatory arthritis: post-marketing surveillance study in Thailand.

Background: The infliximab biosimilar CT-P13 was approved in Thailand in 2015. Methods: This open-label, multicenter, post-marketing surveillance study evaluated the safety (events of special interest [ESIs]; primary end point) and effectiveness of 46 weeks of CT-P13 treatment according to routine practice in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA), with 1 year follow-up post-treatment. Results: 30 patients were enrolled (16 RA, 8 AS and 6 PsA). Infections were the most frequently reported study drug-related ESIs (2 RA and 2 AS). One patient with RA and one with PsA experienced infusion-related reactions. No cases of tuberculosis, malignancy (as expected, given 1 year follow-up), or drug-induced liver disease were reported. Disease activity improved across indications. Conclusion: CT-P13 was well tolerated and effective across indications.

Infliximab is one biological medicine used to treat inflammatory diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). CT-P13 is a near-identical copy, called a biosimilar, of the original ('reference') version of infliximab. CT-P13 is the first biosimilar to receive regulatory approval for treatment of the same three diseases from the European Medicines Agency (EMA) and US Food and Drug Administration. Biosimilarity means that CT-P13 does not differ from the original version of infliximab in clinically important ways, such as how safe it is and how well it works. CT-P13 and reference infliximab provided similar symptom relief during previous clinical trials, and both drugs caused similar side effects. It is important to monitor the safety and performance of CT-P13 when given during routine clinical practice, and in different ethnic populations, such as through the study reported here. Following regulatory approval in Thailand, 30 patients prescribed CT-P13 during routine clinical practice participated in this study. The study included 16 patients with RA, eight with AS and six with PsA. The patients took CT-P13 for 46 weeks and were monitored for a further year. Side effects of CT-P13 were as expected based on previous experience and did not raise any safety concerns. Based on the known safety profile of CT-P13, the study looked at some side effects in particular: infections were the most common of these side effects, experienced by 16 patients overall (seven patients with RA, five patients with AS and four patients with PsA). CT-P13 improved symptoms for all of the diseases. The study suggests that CT-P13 can be given safely and reduces symptoms in Thai patients with AS, RA or PsA. Thai Clinical Trials Registry: TCTR20170817005 (www.thaiclinicaltrials.org/show/TCTR20170817005).

Humoral SARS-CoV-2 immunogenicity wanes 3 months after heterologous inactivated vaccine followed by ChAdOx1 nCoV-19 in autoimmune rheumatic diseases.

BACKGROUND: Alongside vaccine hesitancy, impaired and waning immunity in autoimmune rheumatic diseases (ARDs) are barriers to immunization. The timeframe of immunity waning in ARD remains unclear. OBJECTIVE: We aimed to examine the waning of humoral immunogenicity in a cohort of ARD patients who received the heterologous inactivated vaccine followed by the adenoviral vector SAR-CoV-2 vaccine at a 3-month follow-up. METHODS: The levels of SARS-CoV-2 anti-RBD IgG were evaluated at 1 and 3 months in adults with ARDs (n = 29) and age- and sex-matched healthy controls (HC) that received the heterologous prime-boost CoronaVac vaccine followed by the ChAdOx1 nCoV-19 vaccine. Seropositivity was defined as anti-receptor binding domain (RBD) IgG levels of ≥ 7.15 binding antibody units (BAU)/mL. The kinetic properties of the vaccines were evaluated based on the ratio of anti-RBD IgG values obtained at each follow-up. Disease activity was evaluated. RESULTS: The seropositivity rate was lower among patients with ARDs than among HCs (89.7% vs. 100%, p = 0.237). At 3 months, the median (IQR) anti-RBD IgG level was lower among patients with ARDs than among HCs (122.3 [30.6, 247.8] vs. 294.2 [127.4,605.7] BAU/mL, p = 0.006). Mean antibody levels in patients with ARDs decreased 3.5 (1.9)-fold within 3 months post-vaccination (122.3 [30.6, 247.8] vs. 279.9 [86,1076.5] BAU/mL, p < 0.001). Disease flare-ups occurred in three patients. CONCLUSIONS: Our findings included changes to anti-RBD IgG levels and may inform vaccination strategies. SAR-CoV2 vaccine-induced immunity was lower in patients with ARDs than in HCs and decreased within 3 months, suggesting a need for booster vaccinations.

2016 updated Thai Rheumatism Association Recommendations for the use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis.

AIM: In June 2015, the Thai Rheumatism Association (TRA) approved an update of its recommendation for the use of biologic disease-modifying anti-rheumatic drugs (bDMARDs) and targeted synthetic (tsDMARD) in the treatment of rheumatoid arthritis (RA) to cover those currently available in Thailand (etanercept, infliximab, golimumab, rituximab, tocilizumab, abatacept and tofacitinib). METHOD: A search of the literature was performed between January 2000 and June 2015. Existing RA recommendations, in relation to the use of bDMARDs and tsDMARD, were identified and evaluated by the AGREE II instrument prior to their use as a 'guide' for developing this TRA recommendation. An additional literature search was performed in order to answer specific clinical questions that could not be found in existing guidelines. RESULT: Thirteen recommendations were developed. They covered the use of RA classification criteria, the aim of RA treatment, when to initiate bDMARDs/tsDMARD or taper or switch them to other medications, as well as monitoring these drugs during their use. In addition, specific issues including their use and vaccination, malignancies, pregnancy and lactation, and perioperative period also were addressed. Public hearings were performed at the annual meeting of the TRA and of the Royal College of Physicians of Thailand. The recommendations were distributed to other professional associations related to RA management, as well as government sectors associated with the reimbursement policy, prior to development of the final version. CONCLUSION: These recommendations will help Thai rheumatologists prescribe bDMARDs and tsDMARD more appropriately when treating RA patients.