Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety Assessment of Biologic ThERapy (SABER) study

John W. Baddley, Kevin Winthrop, Lang Chen, Liyan Liu, Carlos G. Grijalva, Elizabeth Delzell, Timothy Beukelman, Nivedita M. Patkar, Fenglong Xie, Kenneth G. Saag, Lisa J. Herrinton, Daniel H. Solomon, James D. Lewis, Jeffrey R. Curtis

Research output: Contribution to journalArticle

50 Citations (Scopus)

Abstract

OBJECTIVES: To determine among patients with autoimmune diseases in the USA whether the risk of non-viral opportunistic infections (OI) was increased among new users of tumour necrosis factor α inhibitors (TNFI), when compared to users of non-biological agents used for active disease.

METHODS: We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease and psoriasis-psoriatic arthritis-ankylosing spondylitis patients during 1998-2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programmes for the elderly, Tennessee Medicaid and US Medicaid/Medicare programmes. We compared incidence of non-viral OI among new TNFI users and patients initiating non-biological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid- adjusted OI incidence between new TNFI and non-biological DMARD users.

RESULTS: Within a cohort of 33 324 new TNFI users we identified 80 non-viral OI, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OI among new users of TNFI compared to those initiating non-biological DMARD was 2.7 versus 1.7 per 1000-person-years (aHR 1.6, 95% CI 1.0 to 2.6). Baseline corticosteroid use was associated with non-viral OI (aHR 2.5, 95% CI 1.5 to 4.0). In the RA cohort, rates of non-viral OI among new users of infliximab were higher when compared to patients newly starting non-biological DMARD (aHR 2.6, 95% CI 1.2 to 5.6) or new etanercept users (aHR 2.9, 95% CI 1.5 to 5.4).

CONCLUSIONS: In the USA, the rate of non-viral OI was higher among new users of TNFI with autoimmune diseases compared to non-biological DMARD users.

Original languageEnglish (US)
Pages (from-to)1942-1948
Number of pages7
JournalAnnals of the Rheumatic Diseases
Volume73
Issue number11
DOIs
StatePublished - Nov 1 2014

Fingerprint

Biological Therapy
Opportunistic Infections
Antirheumatic Agents
Tumor Necrosis Factor-alpha
Safety
Medicaid
Therapeutics
Drug Users
Autoimmune Diseases
Rheumatoid Arthritis
Propensity Score
Psoriatic Arthritis
Pneumocystis Pneumonia
Ankylosing Spondylitis
Incidence
Medicare
Inflammatory Bowel Diseases
Psoriasis
Proportional Hazards Models
Adrenal Cortex Hormones

Keywords

  • DMARDs (biologic)
  • Infections
  • Rheumatoid Arthritis
  • TNF-alpha
  • Tuberculosis

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy : results of the SAfety Assessment of Biologic ThERapy (SABER) study. / Baddley, John W.; Winthrop, Kevin; Chen, Lang; Liu, Liyan; Grijalva, Carlos G.; Delzell, Elizabeth; Beukelman, Timothy; Patkar, Nivedita M.; Xie, Fenglong; Saag, Kenneth G.; Herrinton, Lisa J.; Solomon, Daniel H.; Lewis, James D.; Curtis, Jeffrey R.

In: Annals of the Rheumatic Diseases, Vol. 73, No. 11, 01.11.2014, p. 1942-1948.

Research output: Contribution to journalArticle

Baddley, JW, Winthrop, K, Chen, L, Liu, L, Grijalva, CG, Delzell, E, Beukelman, T, Patkar, NM, Xie, F, Saag, KG, Herrinton, LJ, Solomon, DH, Lewis, JD & Curtis, JR 2014, 'Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety Assessment of Biologic ThERapy (SABER) study', Annals of the Rheumatic Diseases, vol. 73, no. 11, pp. 1942-1948. https://doi.org/10.1136/annrheumdis-2013-203407
Baddley, John W. ; Winthrop, Kevin ; Chen, Lang ; Liu, Liyan ; Grijalva, Carlos G. ; Delzell, Elizabeth ; Beukelman, Timothy ; Patkar, Nivedita M. ; Xie, Fenglong ; Saag, Kenneth G. ; Herrinton, Lisa J. ; Solomon, Daniel H. ; Lewis, James D. ; Curtis, Jeffrey R. / Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy : results of the SAfety Assessment of Biologic ThERapy (SABER) study. In: Annals of the Rheumatic Diseases. 2014 ; Vol. 73, No. 11. pp. 1942-1948.
@article{b902a4daa20746b9981dfb21c8f81875,
title = "Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety Assessment of Biologic ThERapy (SABER) study",
abstract = "OBJECTIVES: To determine among patients with autoimmune diseases in the USA whether the risk of non-viral opportunistic infections (OI) was increased among new users of tumour necrosis factor α inhibitors (TNFI), when compared to users of non-biological agents used for active disease.METHODS: We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease and psoriasis-psoriatic arthritis-ankylosing spondylitis patients during 1998-2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programmes for the elderly, Tennessee Medicaid and US Medicaid/Medicare programmes. We compared incidence of non-viral OI among new TNFI users and patients initiating non-biological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid- adjusted OI incidence between new TNFI and non-biological DMARD users.RESULTS: Within a cohort of 33 324 new TNFI users we identified 80 non-viral OI, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OI among new users of TNFI compared to those initiating non-biological DMARD was 2.7 versus 1.7 per 1000-person-years (aHR 1.6, 95{\%} CI 1.0 to 2.6). Baseline corticosteroid use was associated with non-viral OI (aHR 2.5, 95{\%} CI 1.5 to 4.0). In the RA cohort, rates of non-viral OI among new users of infliximab were higher when compared to patients newly starting non-biological DMARD (aHR 2.6, 95{\%} CI 1.2 to 5.6) or new etanercept users (aHR 2.9, 95{\%} CI 1.5 to 5.4).CONCLUSIONS: In the USA, the rate of non-viral OI was higher among new users of TNFI with autoimmune diseases compared to non-biological DMARD users.",
keywords = "DMARDs (biologic), Infections, Rheumatoid Arthritis, TNF-alpha, Tuberculosis",
author = "Baddley, {John W.} and Kevin Winthrop and Lang Chen and Liyan Liu and Grijalva, {Carlos G.} and Elizabeth Delzell and Timothy Beukelman and Patkar, {Nivedita M.} and Fenglong Xie and Saag, {Kenneth G.} and Herrinton, {Lisa J.} and Solomon, {Daniel H.} and Lewis, {James D.} and Curtis, {Jeffrey R.}",
year = "2014",
month = "11",
day = "1",
doi = "10.1136/annrheumdis-2013-203407",
language = "English (US)",
volume = "73",
pages = "1942--1948",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",
number = "11",

}

TY - JOUR

T1 - Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy

T2 - results of the SAfety Assessment of Biologic ThERapy (SABER) study

AU - Baddley, John W.

AU - Winthrop, Kevin

AU - Chen, Lang

AU - Liu, Liyan

AU - Grijalva, Carlos G.

AU - Delzell, Elizabeth

AU - Beukelman, Timothy

AU - Patkar, Nivedita M.

AU - Xie, Fenglong

AU - Saag, Kenneth G.

AU - Herrinton, Lisa J.

AU - Solomon, Daniel H.

AU - Lewis, James D.

AU - Curtis, Jeffrey R.

PY - 2014/11/1

Y1 - 2014/11/1

N2 - OBJECTIVES: To determine among patients with autoimmune diseases in the USA whether the risk of non-viral opportunistic infections (OI) was increased among new users of tumour necrosis factor α inhibitors (TNFI), when compared to users of non-biological agents used for active disease.METHODS: We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease and psoriasis-psoriatic arthritis-ankylosing spondylitis patients during 1998-2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programmes for the elderly, Tennessee Medicaid and US Medicaid/Medicare programmes. We compared incidence of non-viral OI among new TNFI users and patients initiating non-biological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid- adjusted OI incidence between new TNFI and non-biological DMARD users.RESULTS: Within a cohort of 33 324 new TNFI users we identified 80 non-viral OI, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OI among new users of TNFI compared to those initiating non-biological DMARD was 2.7 versus 1.7 per 1000-person-years (aHR 1.6, 95% CI 1.0 to 2.6). Baseline corticosteroid use was associated with non-viral OI (aHR 2.5, 95% CI 1.5 to 4.0). In the RA cohort, rates of non-viral OI among new users of infliximab were higher when compared to patients newly starting non-biological DMARD (aHR 2.6, 95% CI 1.2 to 5.6) or new etanercept users (aHR 2.9, 95% CI 1.5 to 5.4).CONCLUSIONS: In the USA, the rate of non-viral OI was higher among new users of TNFI with autoimmune diseases compared to non-biological DMARD users.

AB - OBJECTIVES: To determine among patients with autoimmune diseases in the USA whether the risk of non-viral opportunistic infections (OI) was increased among new users of tumour necrosis factor α inhibitors (TNFI), when compared to users of non-biological agents used for active disease.METHODS: We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease and psoriasis-psoriatic arthritis-ankylosing spondylitis patients during 1998-2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programmes for the elderly, Tennessee Medicaid and US Medicaid/Medicare programmes. We compared incidence of non-viral OI among new TNFI users and patients initiating non-biological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid- adjusted OI incidence between new TNFI and non-biological DMARD users.RESULTS: Within a cohort of 33 324 new TNFI users we identified 80 non-viral OI, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OI among new users of TNFI compared to those initiating non-biological DMARD was 2.7 versus 1.7 per 1000-person-years (aHR 1.6, 95% CI 1.0 to 2.6). Baseline corticosteroid use was associated with non-viral OI (aHR 2.5, 95% CI 1.5 to 4.0). In the RA cohort, rates of non-viral OI among new users of infliximab were higher when compared to patients newly starting non-biological DMARD (aHR 2.6, 95% CI 1.2 to 5.6) or new etanercept users (aHR 2.9, 95% CI 1.5 to 5.4).CONCLUSIONS: In the USA, the rate of non-viral OI was higher among new users of TNFI with autoimmune diseases compared to non-biological DMARD users.

KW - DMARDs (biologic)

KW - Infections

KW - Rheumatoid Arthritis

KW - TNF-alpha

KW - Tuberculosis

UR - http://www.scopus.com/inward/record.url?scp=84964312661&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84964312661&partnerID=8YFLogxK

U2 - 10.1136/annrheumdis-2013-203407

DO - 10.1136/annrheumdis-2013-203407

M3 - Article

C2 - 23852763

AN - SCOPUS:84964312661

VL - 73

SP - 1942

EP - 1948

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 11

ER -