Monday, 22 Jan 2018

You are here

Baseline Risk Score Predicts Serious Infection Risk in TNF-Treated RA Patients

Curtis and colleagues have analyzed the certolizumab (CZP) RAPID1 and RAPID2 trials to assess the risk of serious infectious events (SIEs), and shown that steroids combined with an age-adjusted comorbidity index (AACI) yields a 2-3 fold predictable risk for SIE.

Their goal was to develop an infection risk score that may help clinicians to anticipate a patients potential SIE.  Data from other studies have shown that disease activity, drugs, steroids, and comorbidities significantly augments this risk.

The AACI was developed by assigning specific weights to patient age and comorbidities on the basis of relative SIE risk. SIE rates were predicted using AACI score and baseline glucocorticoid use, and they were compared with observed rates.

Among the 1224 CZP patients in the randomized controlled trials (RCT) there were 40 reported with an SIE (incidence rate [IR] 5.09/100 patient-years [PY]).  When considering all 1506 CZP exposed (including the open-label extensions) patients there were 201 with ≥ 1 SIE (IR 3.66/100 PY).

Age ≥ 70 years, diabetes mellitus, and chronic obstructive pulmonary disease/asthma made the greatest contributions to AACI score. Each was given a baseline risk score of 1-3 (age 50-69=1; age>70=3; 2 points each for COPD, DM, Hyperlipidemia and osteoporosis).

AACI scores ≥ 2 with glucocorticoid use was associated with nearly a 3 fold higher SIE risk (RCT CZP HR 2.86 [1.23–6.62]; All CZP HR 2.59 [1.79–3.76]) compared to those with AACI of 0.

SIE rates predicted using AACI and glucocorticoid use at baseline showed good agreement with observed SIE rates across low-risk and high-risk groups.

At 1 year, more high-risk All CZP patients than low-risk All CZP patients reported SIEs (IR 8.4/100 PY vs. IR 3.4/100 PY).

AACI and glucocorticoid use were strong baseline predictors of SIE risk in CZP-treated patients with RA. 

The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Prevention of HBV Infection: How Are We Doing?

In 2016 the WHO set out to eliminate HBV infection as a public health threat by 2030. So far, we are far from this goal as vaccine implementation has been suboptimal in a number of important patient populations, including patients with rheumatologic diseases, as well as other immunocompromising diseases like HIV.

B Cell Changes Predict Autoimmunity with Checkpoint Inhibitors

The Journal of Clinical Investigation reports results of a study showing that increases in CD21lo B cells and plasmablasts following that combination checkpoint blockade preceded the onset of immune-related adverse events.

While some have postulated that IRAEs are thought to be T cell mediated, B cells have also been implicated. Investigators studied 39 melanoma patients undergoing treatment with either anti-CTLA4 or anti-PD1, or combination CCB therapy. They analyzed changes in circulating B cells before and after the first cycle of therapy of immune checkpoint blockade (23 received combination therapy, 8 received anti-CTLA4, and 8 received anti-PD1).

Ibuprofen’s Anti-androgenic Effect May Result in Hypogonadism in Males

PNAS reports use of ibuprofen by males may result in antiandrogen effects that may contribute to adult male reproductive problems.

Sorting Out the Complexities of Autoimmunity with Immune Checkpoint Inhibitor Therapy

An editorial and systematic review of complications seen when checkpoint inhibitor (CPI) therapies are given to patients with immune mediated inflammatory disorders (IMIDs) and cancer shows that nearly 75% manifest autoimmune and inflammatory immune-related adverse events (irAEs).

Advantages of Intravenous Pulse Cyclophosphamide in ANCA-associated Vasculitis

Researchers from the Nottingham University Hospitals have analyzed the efficacy and safety of  oral (PO) and intravenous (IV)  cyclophosphamide (CTX) in ANCA-associated vasculitis (AAV) patients and demonstrated a trend for fewer relapses, better 1 year survival and less toxicity with IV CTX.