Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
Biological therapies (BT) have significantly improved the prognosis of chronic inflammatory arthritis (CIA) patients. Although they are characterized by a good safety profile, the presence of adverse events (AE) might limit their use. Despite their importance, neither the distribution of AE during treatment nor the risk of a recurrent event has been adequately estimated. The objective of this study was to analyze the incidence, distribution in time and the risk of recurrence of infectious AE (IAE) in CIA patients during BT
Methods
290 CIA patients (i.e. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis) treated with at least 1BT during the period between December ’99 – March ’13 were included. From all these patients a large retrospective clinical data set of 615 BTs could be collected.
The incidence rate (IR) was calculated as the total number of AE per 1,000 patients / year. The difference in the risk of an AE between the 3 CIA was analyzed using the Cox and Poisson regression models. To evaluate temporal distribution and recurrence of IAE, the IR was analyzed at multiple time intervals. Only those IAE with at least 10 recurrences were included.
The analysis of the recurrence was based on a regression model of Cox proportional hazards. Time to failure (TTF) was defined as the time interval between the initiation of the BT and the first IAE. For recurrent events, was defined as the time interval between a recurrent event and the previous one.
Results
A total of 1,361 AE were found. Comparing the 3 CIA, the risk of a first AE was higher for RA, although this was not significant. The Cox and Poisson regression models showed a high degree of concordance between the 3 CIA.
738 IAE with at least 10 recurrences were identified. From these, 485 were respiratory infections (RI), 73 urinary infections (UI), 67 gastrointestinal infections (GII), 58 herpetic infections (HI) and 55 oral cavity infections (OCI).
The probability of a first RI was greatest during the first 48 wks of BT. When all RI (first event and recurrences) were considered, we found a homogeneous distribution over time. In the Cox model, we observed that RI was significantly associated with an increased risk of recurrence (p-value = 7.99e-03, HR = 1.08 [95% CI 1.2-1.14]).
UI showed a less homogeneous distribution over time and there was a greater risk of UI in the first 48 wks of treatment. The probability of recurrence was highly significant (p-value = 1.67e-10, HR = 1.96 [95% CI 1.59-2.41]).
The probability of a first GII showed a maximum in the first 12 wks and he risk of recurrence was not significantly (p-value =6.81e-02; HR=1.55 [95% CI 0.97-2.49]).
In the distribution of the HI, we found a maximum during the first 48 wks, and a significant risk of recurrence (p-value = 2.78E-03, HR = 1.91 [95% CI 1.25-2.91]).
The distribution of OCI showed two maxima, and the risk of recurrence was highly significant (p-value = 5.21e-06, HR [95% CI 1.53-2.92]).
Conclusion
In our series of Chronic Inflammatory Arthritis treated with BT we found no significant differences in the risk of a first AE between the three CIA. In the recurrence analysis, UI and OCI had a highly significant risk of recurrence, whereas the recurrence risk in GII was minimal.
Disclosure:
G. Avila,
None;
A. Alonso,
None;
A. Pluma-Sanjurjo,
None;
C. Diaz,
None;
R. Juverdeanu,
None;
M. A. López-Lasanta,
None;
S. Marsal,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/risk-analysis-of-a-first-adverse-event-and-recurrent-infections-during-biological-therapy-in-chronic-inflammatory-arthritis/