Effectiveness and safety of subcutaneous abatacept in biologic-naïve RA patients at Week 52: A Japanese multicentre investigational study (ORIGAMI study).

OBJECTIVES: To evaluate the effectiveness and safety of abatacept over 52 weeks in biologic-naïve rheumatoid arthritis (RA) patients with moderate disease activity in the prospective, 5-year, observational study (ORIGAMI study) in Japan. METHODS: Abatacept (125 mg) was administered subcutaneously once a week. Clinical outcomes included Simplified Disease Activity Index (SDAI) remission at Week 52 (primary endpoint), Japanese Health Assessment Questionnaire (J-HAQ), EuroQol 5-Dimension Questionnaire (EQ-5D), treatment retention, and safety. The results were compared with those of conventional synthetic disease-modifying antirheumatic drug (csDMARD) controls from the ongoing Institute of Rheumatology, Rheumatoid Arthritis (IORRA) registry. RESULTS: Overall, 325 patients were enrolled, with a mean age of 66.9 ± 12.7 years. The proportion of patients achieving SDAI remission (≤3.3) at Week 52 was 18.9% (95% CI: 14.3-23.6) and low disease activity (≤11) was 53.3% (95% CI: 47.4-59.1). A significant improvement was observed in J-HAQ and EQ-5D over 52 weeks in both the abatacept and csDMARD groups. The probability of abatacept treatment retention at Week 52 was 69.9% (95% CI: 64.7-75.5). Adverse events and serious adverse events were reported in 50.0% and 12.1% of patients, respectively. CONCLUSIONS: Abatacept significantly improved disease activity, physical disability, and quality of life for up to 52 weeks in RA patients in a real-world setting.

New adalimumab formulation associated with less injection site pain and improved motivation for treatment.

Objectives: We aimed to evaluate the effect of change to the existing formulation of adalimumab (ADA) on pain and treatment motivation.Methods: We classified injection pain into the following categories: overall pain, pain at needle insertion, pain during drug injection, and pain 10 min after injection; we evaluated the effect of change to the existing formulation on pain using a visual analogue scale. In addition, a faces pain scale was used to evaluate the effect of change in injection pain intensity on treatment motivation.Results: Compared with the existing ADA formulation, the new formulation was associated with lower scores of overall pain (1.6 vs. 6.7), pain at needle insertion (1.8 vs. 4.7), pain during injection (1.6 vs. 7.0), and pain 10 min after the injection (0.4 vs. 3.1). All results showed a significant difference. p < .001. Paired t-tests were used. In the survey, 68% and 80% of the patients reported injection pain with influenza vaccine and the existing formulation, respectively; however, the proportion of the patients who experienced pain with the new formulation decreased to 20%.Conclusions: The new ADA formulation may alleviate the burden on RA patients and improve the quality of adherence to treatment, thereby influencing the RA treatment outcomes.

Retrospective investigation of side effects and prognoses of moderate-dose trimethoprim-sulfamethoxazole treatment for pneumocystis pneumonia that developed in patients with autoimmune diseases.

Trimethoprim-sulfamethoxazole (TMP/SMX) treatment for pneumocystis pneumonia (PCP) in patients with autoimmune diseases who developed PCP was conducted in a retrospective study of the following: dosage, frequency of side effects and persistence rate of TMP/SMX and prognosis of patients. Seven patients (two males and five females, mean age: 72 years) were hospitalized between April 1, 2013 and August 31, 2015, and their underlying diseases were rheumatoid arthritis (six patients) and microscopic polyangiitis (one patient). Moderate-dose TMP/SMX (TMP equivalent to TMP/SMX, average: 9.6 mg/kg/day, range: 5.1-12.5 mg/kg/day) was used for PCP treatment. As a result, patients experienced the following side effects: hyponatremia in five patients (71.4%), exanthema in four patients (57.1%), and thrombocytopenia in two patients (28.6%). Elevated creatinine level, increased blood pressure, malaise, and hyperkalemia were experienced by each patient. Six patients (85.7%) discontinued TMP/SMX treatment due to side effects, but once they had recovered, desensitization to TMP/SMX was used to treat them. Eventually, four patients were successfully treated with TMP/SMX (final persistence rate, 57.1%). Their prognoses were good, and no patients died for at least 60 days after admission. Moderate-dose TMP/SMX treatment for PCP in patients with autoimmune diseases who developed PCP may have therapeutic effects equal to high-dose TMP/SMX treatment, and therefore collecting more case studies is expected.