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Study flow diagram.
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Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 1 Relapse at 12, 18 or 24 months.
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Analysis 1.1

Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 1 Relapse at 12, 18 or 24 months.

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Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 2 New CD‐related complications.
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Analysis 1.2

Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 2 New CD‐related complications.

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Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 3 Adverse events.
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Analysis 1.3

Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 3 Adverse events.

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Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 4 Serious adverse events.
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Analysis 1.4

Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 4 Serious adverse events.

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Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 5 Withdrawal due to adverse events.
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Analysis 1.5

Comparison 1 Usual care versus immunosuppressive withdrawal after monotherapy, Outcome 5 Withdrawal due to adverse events.

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Comparison 2 Usual care versus immunosuppressive withdrawal after combination therapy, Outcome 1 Relapse at 12 or 24 months.
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Analysis 2.1

Comparison 2 Usual care versus immunosuppressive withdrawal after combination therapy, Outcome 1 Relapse at 12 or 24 months.

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Comparison 2 Usual care versus immunosuppressive withdrawal after combination therapy, Outcome 2 Adverse events.
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Analysis 2.2

Comparison 2 Usual care versus immunosuppressive withdrawal after combination therapy, Outcome 2 Adverse events.

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Comparison 2 Usual care versus immunosuppressive withdrawal after combination therapy, Outcome 3 Serious adverse events.
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Analysis 2.3

Comparison 2 Usual care versus immunosuppressive withdrawal after combination therapy, Outcome 3 Serious adverse events.

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Summary of findings for the main comparison. Usual care compared to immunosuppressive withdrawal after monotherapy for patients with quiescent Crohn's disease

Usual care compared to immunosuppressive withdrawal after monotherapy for patients with quiescent Crohn's disease

Patient or population: Patients with quiescent Crohn's disease
Setting: Outpatient
Intervention: Usual care
Comparison: Immunosuppressive withdrawal after monotherapy

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with immunosuppressive

withdrawal after monotherapy

Risk with usual care

Relapse at 12, 18 or 24 months

Study population

RR 0.42
(0.24 to 0.72)

215
(4 RCTs)

⊕⊕⊝⊝
LOW 1 2

Sparse data (50 events)

324 per 1,000

136 per 1,000
(78 to 234)

New CD‐related complications

Study population

RR 0.34
(0.06 to 2.08)

135
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 3 4

Very sparse data (5 events)

58 per 1,000

20 per 1,000
(3 to 121)

Adverse events

Study population

RR 0.88
(0.67 to 1.17)

186
(3 RCTs)

⊕⊕⊝⊝
LOW 2 5

Sparse data (45 events)

240 per 1,000

211 per 1,000
(161 to 280)

Serious adverse events

Study population

RR 3.29
(0.35 to 30.80)

134
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 3 4

Very sparse data (2 events)

0 per 1,000

0 per 1,000
(0 to 0)

Withdrawal due to adverse events

Study population

RR 2.59
(0.35 to 19.04)

135
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 3 4

Very sparse data (5 events)

14 per 1,000

38 per 1,000
(5 to 276)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded one level due to high risk of bias for blinding in one study and unclear risk of bias in three studies in the pooled analysis

2 Downgraded one level due to sparse data

3 Downgraded one level due to unclear risk of bias in the two studies in the pooled analysis

4 Downgraded two levels due to very sparse data

5 Downgraded one level due to unclear risk of bias in the three studies in the pooled analysis

Figuras y tablas -
Summary of findings for the main comparison. Usual care compared to immunosuppressive withdrawal after monotherapy for patients with quiescent Crohn's disease
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Summary of findings 2. Usual care compared to immunosuppressive withdrawal after combination therapy for patients with quiescent Crohn's disease

Usual care compared to immunosuppressive withdrawal after combination therapy for patients with quiescent Crohn's disease

Patient or population: Patients with quiescent Crohn's disease
Setting: Outpatient
Intervention: Usual care
Comparison: Immunosuppressive withdrawal after combination therapy

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with immunosuppressive

withdrawal after combination therapy

Risk with usual care

Relapse at 12 or 24 months

Study population

RR 1.02
(0.68 to 1.52)

111
(2 RCTs)

⊕⊕⊝⊝
LOW 1 2

Sparse data (54 events)

491 per 1,000

501 per 1,000
(334 to 746)

Adverse events

Study population

RR 1.11
(0.44 to 2.81)

111
(2 RCTs)

⊕⊕⊝⊝
LOW 1 2

Sparse data (51 events)

455 per 1,000

505 per 1,000
(200 to 1,000)

Serious adverse events

Study population

RR 1.00
(0.21 to 4.66)

80
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 3

Very sparse data (6 events)

75 per 1,000

75 per 1,000
(16 to 350)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded one level due to high risk of bias for blinding

2 Downgraded one level due to sparse data

3 Downgraded two levels due to very sparse data

Figuras y tablas -
Summary of findings 2. Usual care compared to immunosuppressive withdrawal after combination therapy for patients with quiescent Crohn's disease
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Table 1. Sensitivity analysis: random effects vs fixed effect modelling

Comparison 1: Usual care versus immunosuppressive withdrawal after monotherapy

Outcome

Random Effects RR (95% CI)

Fixed Effect RR (95% CI)

Impact

1.1 Relapse at 12, 18 or 24 months

0.42 (0.24‐0.72)

0.42 (0.24‐0.72)

No change

1.2 New CD‐related complications

0.34 (0.06‐2.08)

0.34 (0.06‐2.08)

No change

1.3 Adverse events

0.88 (0.67‐1.17)

0.97 (0.71‐1.32)

Minimal

1.4 Serious adverse events

3.29 (0.35‐30.80)

3.29 (0.35‐30.80)

No change

1.5 Withdrawal due to adverse events

2.59 (0.35‐19.04)

3.10 (0.49‐19.41)

Minimal

Comparison 2: Usual care versus Immunosuppressive withdrawal after combination therapy

Outcome

Random Effects RR (95% CI)

Fixed Effect RR (95% CI)

2.1 Relapse at 12 or 24 months

1.02 (0.68‐1.52)

0.99 (0.69‐1.43)

Minimal

2.2 Adverse events

1.11 (0.44‐2.81)

1.04 (0.73‐1.47)

Minimal

2.3 Serious adverse events

No pooling

No pooling

No pooling
Figuras y tablas -
Table 1. Sensitivity analysis: random effects vs fixed effect modelling
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Table 2. Definition of remission by study

Study

Length of remission prior to drug withdrawal

Definition of remission prior to drug withdrawal

Roblin 2017

Minimum 6 months

CDAI ≤ 150 and fecal calprotectin levels < 250 μg/g

Lémann 2005

Mean 62 months (standard deviation 26 months); Minimum 42 months

Clinical remission (CDAI ≤ 150) and no need for medical/surgical therapy in the previous 42 months

O'Donoghue 1978

Minimum 6 months

Clinical remission not otherwise specified

Van Assche 2008

Minimum 6 months

Clinical response to infliximab and disease control

Vilien 2004

Not specified

Clinical remission: physician's global assessment

Wenzl 2015

Minimum 12 months

Clinical remission, no need for new medical therapy in the previous 12 months
Figuras y tablas -
Table 2. Definition of remission by study
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Comparison 1. Usual care versus immunosuppressive withdrawal after monotherapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Relapse at 12, 18 or 24 months Show forest plot

4

215

Risk Ratio (M‐H, Random, 95% CI)

0.42 [0.24, 0.72]

2 New CD‐related complications Show forest plot

2

135

Risk Ratio (M‐H, Random, 95% CI)

0.34 [0.06, 2.08]

3 Adverse events Show forest plot

3

186

Risk Ratio (M‐H, Random, 95% CI)

0.88 [0.67, 1.17]

4 Serious adverse events Show forest plot

2

134

Risk Ratio (M‐H, Random, 95% CI)

3.29 [0.35, 30.80]

5 Withdrawal due to adverse events Show forest plot

2

135

Risk Ratio (M‐H, Random, 95% CI)

2.59 [0.35, 19.04]
Figuras y tablas -
Comparison 1. Usual care versus immunosuppressive withdrawal after monotherapy
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Comparison 2. Usual care versus immunosuppressive withdrawal after combination therapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Relapse at 12 or 24 months Show forest plot

2

111

Risk Ratio (M‐H, Random, 95% CI)

1.02 [0.68, 1.52]

2 Adverse events Show forest plot

2

111

Risk Ratio (M‐H, Random, 95% CI)

1.11 [0.44, 2.81]

3 Serious adverse events Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 2. Usual care versus immunosuppressive withdrawal after combination therapy
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