STORICD · Positioning and de-escalation
Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped
Louis E, et al.
Gastroenterology 2012 · PMID 21945953 (PubMed, opens in a new tab) · doi 10.1053/j.gastro.2011.09.034 (full paper, opens in a new tab)
| Outcome | Result |
|---|---|
| Relapse within 1 year (primary endpoint) | 43.9% ± 5.0% |
| Relapsed during follow-up (median 28 months) | 52 of 115 patients |
| Relapse within 1 year with no more than 2 risk factors (about 29% of patients) | 15% |
| Independent risk factors for relapse (Cox model) | Male sex; no previous surgical resection; leukocytes >6.0 × 10⁹/L; haemoglobin ≤145 g/L; CRP ≥5.0 mg/L; faecal calprotectin ≥300 µg/g |
| Re-treatment with infliximab effective and well tolerated | 88% of patients who relapsed |
Source: Louis 2012, abstract. The hazard ratio for each risk factor is in the full text, which is not in PubMed Central.
Structured abstract
BackgroundMany patients in long remission on infliximab plus an antimetabolite ask to stop infliximab, but the risk of relapse, and who could stop safely, were unknown.
MethodsProspective multicentre cohort study (single arm, not randomised). 115 patients. Primary endpoint: Time to relapse after stopping infliximab, with risk factors identified by Cox model; follow-up at least 1 year.
ResultsPrimary result. 52 of 115 patients relapsed over a median follow-up of 28 months; 1-year relapse rate 43.9% ± 5.0%.
Take-homeAbout half of patients relapse within a year of stopping infliximab from combination therapy, but most regain remission on re-treatment, and biomarkers identify a lower-risk group.
| Patients | 115 |
|---|---|
| Population | Patients treated for at least 1 year with scheduled infliximab plus an antimetabolite and in corticosteroid-free remission for at least 6 months. |
| Comparison | Infliximab stopped, antimetabolite continued (no control group) |
| Drugs | infliximab, antimetabolite |
| Classes | Anti-TNF, Immunomodulator |
| Published | Louis E, et al. Gastroenterology 2012;142:63–70. |
Key points
- Risk factors for relapse: male sex, no previous surgical resection, leukocytes above 6.0 × 10⁹/L, haemoglobin ≤145 g/L, CRP ≥5.0 mg/L and faecal calprotectin ≥300 µg/g.
- Patients with no more than 2 of these risk factors (about 29% of the cohort) had a 15% risk of relapse within 1 year.
- Re-treatment with infliximab was effective and well tolerated in 88% of patients who relapsed.
Limitations
- Not randomised; no continuation arm for comparison (see SPARE).
- Risk score derived and tested in the same cohort.
Commentary
STORI is the classic prospective study of anti-TNF withdrawal in Crohn’s disease and is still the source of the ‘about 50% relapse at 1 year’ figure. The randomised answer came later from SPARE, which showed that stopping the immunosuppressant is the safer de-escalation choice.
If infliximab is stopped, plan close monitoring with calprotectin and CRP and a clear route back to infliximab, which works again in most patients.
Later evidence: two double-blind placebo-controlled trials give different answers. In STOP-IT (2022; 115 patients with Crohn’s disease in deep remission on infliximab), relapse-free survival at week 48 was 100% with continued infliximab vs 51% with placebo (PMID 38319804). In EXIT (2025), where all patients stayed on an immunomodulator and had no significant endoscopic lesions, 1-year sustained remission was 84% with continued anti-TNF vs 76% with placebo (P=0.2). Careful selection and a continued immunomodulator appear to matter.
Journal club
Design
Prospective multicentre cohort study (single arm, not randomised). 115 patients.
Primary result. 52 of 115 patients relapsed over a median follow-up of 28 months; 1-year relapse rate 43.9% ± 5.0%.
Validity and applicability
- Not randomised; no continuation arm for comparison (see SPARE).
- Risk score derived and tested in the same cohort.
Where it sits now
About half of patients relapse within a year of stopping infliximab from combination therapy, but most regain remission on re-treatment, and biomarkers identify a lower-risk group.
- SPARE (2023): If you de-escalate combination therapy in stable Crohn's disease, stop the immunosuppressant, not infliximab; relapse is much less likely.
- EXIT (2025): In carefully selected patients in deep remission who stay on an immunomodulator, stopping the anti-TNF did not significantly reduce 1-year sustained remission, but calprotectin rose more often; withdrawal is an option to discuss, not a default.
Questions for discussion
- The risk score was derived and tested in the same cohort. How much would you trust the 15% low-risk estimate for your own patient?
- 88% of relapsers responded to re-treatment. Does that make a planned withdrawal more acceptable, and for whom?
- How does SPARE, which randomised the same question, change how you counsel a patient who wants to stop infliximab?