Early Combined Immunosuppression may be Effective and Safe in Older Patients With Crohn's Disease

Post Hoc Analysis of REACT

Siddharth Singh; Larry W. Stitt; Guangyong Zou; Reena Khanna; Parambir S. Dulai; William J. Sandborn; Brian G. Feagan; Vipul Jairath

Disclosures

Aliment Pharmacol Ther. 2019;49(9):1188-119. 

In This Article

Results

Baseline Characteristics

Table 1 shows the baseline characteristics of participants by age, and treatment strategy assignment. As compared to younger patients, older patients had longer disease duration (15.6 vs 9.8 years, P < 0.01), more likely to have had undergone prior Crohn's disease-related surgery (55.3% vs 45.6%, P < 0.01), less likely to have active fistula at baseline (3.9% vs 7.9%, P = 0.01) and were less likely to have been on TNFα antagonist monotherapy at baseline (12.5% vs 22.2%, P < 0.01).

Outcomes

Effectiveness outcomes. Table 2 shows the magnitude of the effect of intervention (early combined immunosuppression vs conventional management) between younger and older patients, after adjustment for baseline characteristics noted to be related to each outcome. No significant difference was observed between younger and older patients in the risk of achieving corticosteroid-free clinical remission (<60 years: RR, 1.06 [0.98-1.15] vs ≥60 years: RR 1.09 [0.90-1.33], P-interaction = 0.78) with early combined immunosuppression vs conventional management with estimates favouring early combined immunosuppression, as per the original trial result in all patients at 24 months. Similarly, there was no significant difference in the magnitude of benefit with early combined immunosuppression vs conventional management in younger vs older patients on time to occurrence of composite major adverse outcome (<60 years: HR, 0.71 [0.53-0.96] vs ≥60 years: HR, 0.69 [0.31-1.51], P-interaction = 0.92) (Table 2). There was no significant difference in the magnitude of benefit with early combined immunosuppression for time to serious disease-related complications or time to worsening of Crohn's disease activity.

Safety outcomes. Mortality was higher in older patients (14/311, 4.5%) as compared to younger patients (3/1670, 0.2%), although more deaths were observed in the older group on conventional management compared to early combined immunosuppression. Details of deaths in both groups are shown in Table S1. Cardiopulmonary (eight patients), malignancy (five patients) and sepsis (two patients) were leading causes of death.

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