Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine.

Conditions

Rheumatoid arthritis

Izumi Y, Akazawa M, Akeda Y, Tohma S, Hirano F, Ideguchi H, Matsumura R, Miyamura T, Mori S, Fukui T, Iwanaga N, Jiuchi Y, Kozuru H, Tsutani H, Saisyo K, Sugiyama T, Suenaga Y, Okada Y, Katayama M, Ichikawa K, Furukawa H, Kawakami K, Oishi K, Migita K.

2017-01-2521 citations

10.1186/s13075-016-1207-7

Effect of abatacept on the immunogenicity of 23-valent pneumococcal polysaccharide vaccination (PPSV23) in rheumatoid arthritis patients

Kiyoshi Migita, Yukihiro Akeda, Manabu Akazawa, Shigeto Tohma, Fuminori Hirano et al. (31 authors)

Arthritis Research & Therapy2015-12-0163 citations

10.1186/s13075-015-0863-3

Pneumococcal polysaccharide vaccination in rheumatoid arthritis patients receiving tacrolimus.

Migita K, Akeda Y, Akazawa M, Tohma S, Hirano F, Ideguchi H, Matsumura R, Suematsu E, Miyamura T, Mori S, Fukui T, Izumi Y, Iwanaga N, Tsutani H, Saisyo K, Yamanaka T, Ohshima S, Sugiyama T, Kawabe Y, Katayama M, Suenaga Y, Okamoto A, Ohshima H, Okada Y, Ichikawa K, Yoshizawa S, Kawakami K, Matsui T, Furukawa H, Oishi K.

2015-06-0324 citations

10.1186/s13075-015-0662-x

Interventions

Subcutaneous injection of 23-valent peumococcal polysaccharide vaccine (0.5ml) once. Subcutaneous injection of 0.5ml of saline, once.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with rheumatoid arthritis who regularly visited a facility of the National Hospital Organization (NHO) and met any of the following 5 criteria: 1, Undergoing treatment with a biological drug 2, Having an existing pulmonary disease (RA pulmonary lesion, COPD, old pulmonary tuberculosis or atypical pulmonary mycobacteriosis) 3, Undergoing treatment with steroid (5 mg/day or more when converted to prednisolone) 4, Undergoing treatment with immunosuppressive drugs (including low-molecular compounds) other than MTX 5, Classified as the Steinbrocker stage 3 or 4

Exclusion criteria

Exclusion criteria: 1, Patients who received vaccination with pneumococcal vaccine during last 5 years. 2, Patients who concomitantly developed other autoimmune diseases (excluding Sjogren's syndrome) . 3, Patients who concomitantly developed a malignant tumor (excluding those who were cured for 5 years or longer) . 4, Patients who developed fever within 2 days after a past vaccination and those who developed generalized rash and other symptoms, which were suspected to be allergic symptoms. 5, Patients with a history of seizure. 6, Patients who were diagnosed as having immunological deficiency in the past and those who had relatives with congenital immunodeficiency. 7, Pregnant women, women suspected of being pregnant, and lactating women were excluded, because the safety of the vaccination in pregnant women had not been established. 8, Other patients who were judged to be inappropriate for the study by the primary physician due to unstable clinical conditions caused by serious complications.

Design outcomes

Primary

Measure	Time frame
Pneumococcal pneumonia. Pneumonia from all cases. Invasive pneumococcal disease (IPD).	—

Secondary

Measure	Time frame
Hospitalization for pneumonia. Death from all cases.	—

Countries

Japan

Contacts

Public ContactKiyoshi Migita

National Hospital Organization(NHO) Nagasaki Medical Center Clinical Research Center

Outcome results

None listed