Study | Country | Data source | Study period | Biologic treatment group | Â | None-biologic treatment group | Â | Risk estimate (95%CI) | Adjustment | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Biologic drugs | Number/ cases | Age (years) | Female (%) | Mean/median treatment duration (years) | Control | Number/cases | Age (years) | Female (%) | Mean/median treatment duration (years) | ||||||
RA | |||||||||||||||
Dreyer 2013 | Denmark | The national Danish DANBIO database | 2000–2008 | TNFI | 3347/42 | 54.3 | 73 | 2.9 | Nonbiologic DMARDS | 3812/34 | 61.2 | 74 | 2.1 | HR,1.10 (0.69–1.76) | Age,gender,calendar time |
Wadström 2017 | Sweden | The Swedish Rheumatology Quality of Care Register | 2006–2015 | TNFI | 10,760/54 | 58 | 74 | NR | Conventional systemic DMARDS | 46,416/467 | 64 | 71 | NR | SCC HR,1.09 (0.84–1.42) | Age, gender, start of treatment year, comorbidities, No. of hospitalizations, educational level, days spent in inpatient care |
Abatacept | 2016/17 | 61 | 80 | SCC HR,2.15 (1.31–3.52) | |||||||||||
Rituximab | 3566/24 | 63 | 76 | SCC HR,1.01 (0.66–1.55) | |||||||||||
Tocilizumab | 1788/5 | 59 | 78 | SCC HR,0.93 (0.39–2.21) | |||||||||||
Wolfe 2007 | USA | US National Data Bank for Rheumatic Diseases | 1998–2005 | Infliximab | 4430/161 | 58.5 | 78 | 2.9 | Biologic naïve | NR | 58.5 | 78 | NR | OR,1.7 (1.3–2.2) | Age, gender, educational level, smoking history, baseline patient activity scale, baseline prednisone use |
Etanercept | 3163/126 | 2.7 | OR,1.2 (1.0–1.5) | ||||||||||||
Adalimumab | 812/10 | 1.2 | OR,0.9 (0.5–1.8) | ||||||||||||
Ozen 2019 | USA | US National Data Bank for Rheumatic Diseases | 2005–2015 | Abatacept | 1099/37 | 61.5 | 85.5 | 2.5 | Conventional systemic DMARDS | 1103/20 | 63.3 | 80.9 | 2 | HR,1.05 (0.22- 4.98) | Age, gender, employment status, annual income, education level, smoking status, disease duration, HAQ-Disability Index, pain and patient global scores, BMI, Rheumatic Diseases Comorbidity Index score, any chronic lung disease, diabetes, number of prior bDMARDs, glucocorticoid use, year of study entry, follow-up time |
Solomon 2014 | USA | Corrona RA registry | 2001–2010 | TNFI | 3761/22 | NR | 77.7 | NR | Methotrexate | 1566/17 | NR | 72.3 | NR | HR,0.57 (0.26–1.27) | Age, gender, race, tobacco, alcohol use, BMI, disease duration, serologic status, joint erosions, CDAI, family history of cancer, HAQ, number of past DMARDs used, use of oral glucocorticoids |
Abatacept | 408/5 | NR | 84.1 | HR,1.85 (0.33–10.43) | |||||||||||
Rituximab | 167/1 | NR | 76.7 | HR,1.61 (0.09–28.6) | |||||||||||
Amari 2011 | USA | The Austin Information Technology Center and the pharmacy benefits management | 1998–2008 | TNFI | 4088/283 | 59.6 | 9.6 | NR | Nonbiologic DMARDS | 18,396/1043 | 63.1 | 9.4 | NR | HR,1.42 (1.24–1.63) | Age, gender, race, comorbid diagnoses |
Raaschou 2016 | Sweden | The Swedish Biologics Register | 1998–2012 | BCC TNFI | 8827/236 | 55.3 | 74.8 | 4.2 | BCC Biologic naïve | 43,675/1587 | 61.6 | 71.5 | 4.7 | HR,1.14 (0.98–1.33) | Age, gender, birth year, country of birth, county of residency, educational level, comorbidities until start of follow-up (hospital admissions/outpatient visits for chronic obstructive pulmonary disease, ischemic heart disease, diabetes mellitus, knee/hip joint replacement surgery, psoriatic disease) |
SCC TNFI | 12,558/191 | 55.2 | 75.4 | 5.9 | SCC Biologic naïve | 46,409/847 | 60.9 | 71.5 | 5.1 | HR,1.30 (1.10–1.55) | |||||
Mercer 2017 | UK | British Society for Rheumatology Biologics Register | 2003–2008 | TNFI | 11,704/BCC 150, SCC 23 | 56 | 76 | 4.01 | Nonbiologic DMARDS | 3523/BCC 38, SCC 4 | 60 | 72 | 2.65 | BCC HR,1.20 (0.83 to 1.73) SCC HR,1.79 (0.59 to 5.41) | Age,gender |
Etanercept | 5086/BCC 57 | 56 | 77 | 3.7 | BCC,HR,1.07 (0.70 to 1.63) | ||||||||||
Infliximab | 3663/BCC 59 | 56 | 76 | 2.7 | BCC,HR,1.73 (1.14 to 2.62) | ||||||||||
Adalimumab | 5035/BCC 34 | 57 | 76 | 2.05 | BCC,HR,0.89 (0.56 to 1.42) | ||||||||||
Haynes 2012 | USA | Safety Assessment of Biological Therapeutics | 1998–2007 | TNFI | 19,750/134 | NR | 85.1 | 0.5 | Methotrexate | 9805/77 | NR | 85.8 | 0.3 | HR,1.07 (0.79–1.46) | Propensity scores calculated according to age, sex, race, residence, nursing home/community dwelling, area income, calendar year, number of hospitalizations, outpatient and emergency room visits, number of different medication classes filled, extraarticular disease manifestations, number of intraarticular and orthopedic procedures, number of laboratory tests ordered for inflammatory markers, chronic obstructive pulmonary disease, diabetes, and use of cancer screening tests |
IBD | |||||||||||||||
Haynes 2012 | USA | Safety Assessment of Biological Therapeutics | 1998–2007 | TNFI | 2657/14 | NR | 66.9 | NR | Azathioprine or mercaptopurine | 3700/30 | NR | 65.9 | NR | HR,0.37 (0.13–1.07) | Propensity scores calculated according to age, sex, race, residence, nursing home/community dwelling, area income, calendar year, number of hospitalizations, outpatient and emergency room visits, number of different medication classes filled, extraarticular disease manifestations, number of intraarticular and orthopedic procedures, number of laboratory tests ordered for inflammatory markers, chronic obstructive pulmonary disease, diabetes, and use of cancer screening tests |
Long 2010 | USA | PharMetrics Patient- Centric Database | 1996–2005 | Adalimumab or Infliximab-recent use | 387/14 | 49.7 | 47.6 | NR | None | 1548/36 | 49.2 | 47.6 | NR | CD,HR,2.47 (1.29–4.73) | Age, gender, geographic region, and duration of follow-up |
Adalimumab or Infliximab-persist use | 228/7 | 913/13 | CD,HR,3.23 (1.24–8.45) | ||||||||||||
Psoriasis | |||||||||||||||
Asgari 2017 | USA | Kaiser Permanente Northern California health insurance database | 1998–2011 | Biologics (including adalimumab, etanercept, infliximab, certolizumab, ustekinumab, golimumab, tocilizumab, abatacept, anakinra, and rituximab) | 2285/109 | 47.6 | 47 | 5.86 | Nonbiologic therapy | 3604/251 | 53.1 | 51 | 5.23 | NMSC HR, 1.42 (1.12–1.80) BCC HR, 1.81 (1.23–2.67) SCC HR,1.23 (0.91–1.66) | Age, gender, race/ethnicity, presence of psoriatic arthritis; prior UV light therapy, BMI, and cigarette use |
Kimball 2015 | USA | MarketScan commercial and Medicare Supplemental claims database | 1995–2011 | Etanercept | 6856/316 | 49 | 45.4 | NR | Nonbiologic therapy | 5857/353 | 53 | 55.9 | NR | RR, 1.1 (0.8–1.6) | Age, gender, systemic medication exposure at baseline |
Adalimumab | 3314/175 | 49 | 47.4 | RR, 1.2 (0.7–1.9) | |||||||||||
Infliximab | 1044/51 | 49 | 53.5 | RR, 1.1 (0.4–2.5) | |||||||||||
Haynes 2012 | USA | Safety Assessment of Biological Therapeutics | 1998–2007 | TNFI | 563/ < 5 | NR | 65.2 | NR | Methotrexate | 735/6 | NR | 59.6 | NR | HR,0.35 (0.04–3.43) | Propensity scores calculated according to age, sex, race, residence, nursing home/community dwelling, area income, calendar year, number of hospitalizations, outpatient and emergency room visits, number of different medication classes filled, extraarticular disease manifestations, number of intraarticular and orthopedic procedures, number of laboratory tests ordered for inflammatory markers, chronic obstructive pulmonary disease, diabetes, and use of cancer screening tests |