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Comparison 1 MTX vs No MTX, Outcome 1 Response in the composite index.
Figuras y tablas -
Analysis 1.1

Comparison 1 MTX vs No MTX, Outcome 1 Response in the composite index.

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Comparison 1 MTX vs No MTX, Outcome 2 BASDAI (VAS‐10 cm, 0=no disease activity, 10=severe disease activity).
Figuras y tablas -
Analysis 1.2

Comparison 1 MTX vs No MTX, Outcome 2 BASDAI (VAS‐10 cm, 0=no disease activity, 10=severe disease activity).

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Comparison 1 MTX vs No MTX, Outcome 3 BASFI (score 0‐10, 0=excellent, 10=poor function).
Figuras y tablas -
Analysis 1.3

Comparison 1 MTX vs No MTX, Outcome 3 BASFI (score 0‐10, 0=excellent, 10=poor function).

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Comparison 1 MTX vs No MTX, Outcome 4 Function index (score 0‐40, 0=the best, 40=the worst).
Figuras y tablas -
Analysis 1.4

Comparison 1 MTX vs No MTX, Outcome 4 Function index (score 0‐40, 0=the best, 40=the worst).

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Comparison 1 MTX vs No MTX, Outcome 5 Pain in the day (VAS‐10 cm, 0=no pain, 10=severe pain).
Figuras y tablas -
Analysis 1.5

Comparison 1 MTX vs No MTX, Outcome 5 Pain in the day (VAS‐10 cm, 0=no pain, 10=severe pain).

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Comparison 1 MTX vs No MTX, Outcome 6 Pain in the night (VAS‐10 cm, 0=no pain, 10=severe pain).
Figuras y tablas -
Analysis 1.6

Comparison 1 MTX vs No MTX, Outcome 6 Pain in the night (VAS‐10 cm, 0=no pain, 10=severe pain).

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Comparison 1 MTX vs No MTX, Outcome 7 Spinal pain (VAS 10 cm, 0=no pain, 10=severe).
Figuras y tablas -
Analysis 1.7

Comparison 1 MTX vs No MTX, Outcome 7 Spinal pain (VAS 10 cm, 0=no pain, 10=severe).

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Comparison 1 MTX vs No MTX, Outcome 8 BASMI (VAS‐10 cm, 0=severely limited spinal mobility, 10=overall normal).
Figuras y tablas -
Analysis 1.8

Comparison 1 MTX vs No MTX, Outcome 8 BASMI (VAS‐10 cm, 0=severely limited spinal mobility, 10=overall normal).

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Comparison 1 MTX vs No MTX, Outcome 9 Spondylitis index (score 0‐10, the more severe the disease, the higher the score).
Figuras y tablas -
Analysis 1.9

Comparison 1 MTX vs No MTX, Outcome 9 Spondylitis index (score 0‐10, the more severe the disease, the higher the score).

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Comparison 1 MTX vs No MTX, Outcome 10 Enthesis index (score 0‐90, the more severe the disease, the higher the score).
Figuras y tablas -
Analysis 1.10

Comparison 1 MTX vs No MTX, Outcome 10 Enthesis index (score 0‐90, the more severe the disease, the higher the score).

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Comparison 1 MTX vs No MTX, Outcome 11 Disappearance of peripheral arthritis (event).
Figuras y tablas -
Analysis 1.11

Comparison 1 MTX vs No MTX, Outcome 11 Disappearance of peripheral arthritis (event).

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Comparison 1 MTX vs No MTX, Outcome 12 Patient global assessment (different scales, the more severe the disease, the higher the score).
Figuras y tablas -
Analysis 1.12

Comparison 1 MTX vs No MTX, Outcome 12 Patient global assessment (different scales, the more severe the disease, the higher the score).

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Comparison 1 MTX vs No MTX, Outcome 13 Physician global assessment (different scales, the more severe the disease, the higher the score).
Figuras y tablas -
Analysis 1.13

Comparison 1 MTX vs No MTX, Outcome 13 Physician global assessment (different scales, the more severe the disease, the higher the score).

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Comparison 1 MTX vs No MTX, Outcome 14 Physical well‐being (VAS 100 mm, 0=feeling very well, 100=very bad).
Figuras y tablas -
Analysis 1.14

Comparison 1 MTX vs No MTX, Outcome 14 Physical well‐being (VAS 100 mm, 0=feeling very well, 100=very bad).

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Comparison 1 MTX vs No MTX, Outcome 15 Morning stiffness duration (units not specified in trial report, we assumed minutes).
Figuras y tablas -
Analysis 1.15

Comparison 1 MTX vs No MTX, Outcome 15 Morning stiffness duration (units not specified in trial report, we assumed minutes).

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Comparison 1 MTX vs No MTX, Outcome 16 Severity of morning stiffness (VAS 10 cm, 0=no stiffness, 10=severe).
Figuras y tablas -
Analysis 1.16

Comparison 1 MTX vs No MTX, Outcome 16 Severity of morning stiffness (VAS 10 cm, 0=no stiffness, 10=severe).

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Comparison 1 MTX vs No MTX, Outcome 17 Health assessment questionnaire for spondyloarthropathies (HAQ‐S) (0‐3, 0=no difficulty, 3=unable to do).
Figuras y tablas -
Analysis 1.17

Comparison 1 MTX vs No MTX, Outcome 17 Health assessment questionnaire for spondyloarthropathies (HAQ‐S) (0‐3, 0=no difficulty, 3=unable to do).

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Comparison 1 MTX vs No MTX, Outcome 18 CRP (change from baseline) (percent for Altan, ug/ml for Roychowdhury).
Figuras y tablas -
Analysis 1.18

Comparison 1 MTX vs No MTX, Outcome 18 CRP (change from baseline) (percent for Altan, ug/ml for Roychowdhury).

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Comparison 1 MTX vs No MTX, Outcome 19 ESR (percent change from baseline).
Figuras y tablas -
Analysis 1.19

Comparison 1 MTX vs No MTX, Outcome 19 ESR (percent change from baseline).

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Comparison 1 MTX vs No MTX, Outcome 20 Side effect.
Figuras y tablas -
Analysis 1.20

Comparison 1 MTX vs No MTX, Outcome 20 Side effect.

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Comparison 1 MTX vs No MTX, Outcome 21 Withdrawal for any reason.
Figuras y tablas -
Analysis 1.21

Comparison 1 MTX vs No MTX, Outcome 21 Withdrawal for any reason.

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Table 1. Comparison of baseline parameters between no MTX and MTX group in Altan 2001

Intervention

Function index

Pain in the day

Pain in the night

Spondylitis index

Enthesis index

Patient assessment

Physician assessment

Morning stiffness

MTX

29.12+/‐25.18

3.93+/‐2.06

5.28+/‐2.38

3.31+/‐3.21

7.21+/‐7.46

2.65+/‐1.00

3.09+/‐0.89

53.75+/‐32.62

no MTX

20.89+/‐18.10

4.00+/‐2.80

4.10+/‐3.07

1.00+/‐1.91

3.78+/‐5.02

2.73+/‐0.99

2.21+/‐0.97

21.31+/‐17.88
Figuras y tablas -
Table 1. Comparison of baseline parameters between no MTX and MTX group in Altan 2001
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Table 2. Clinical relevance table ‐ dichotomous

Outcome

#patients(#trials)

Control event rate

Absolute RD

Relative % change

NNT

Stats significance

Quality of evidence

Response to composite index at 24 weeks

35 (1)

16.7% (3/18)

36%

218% (I)

3

statistically significant

silver

Response to composite index: defined by improvement >= 20% at least 5 of following and no worsening in any of the scales (>20% worsening compared to baseline): severity of morning stiffness; physical well being; BASDAI; BASFI; HAQ‐S; physician global assessment; and patient global assessment.
MTX = methotrexate; RR = relative risk, RD = risk difference, NNT = number needed to treat

I=improvement
Figuras y tablas -
Table 2. Clinical relevance table ‐ dichotomous
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Table 3. Clinical relevance table ‐ continuous

Outcome

#patients(#trials)

Ctl baseline mean

Absolute change

Relative % change

NNT

Stats significance

Quality of evidence

BASDAI (0‐10, none to severe)

61 (2)

4.4*

10% (1 more point on 0‐10 scale)

22%(W)

not applicable

not significant

silver

BASFI (0‐10, excellent to poor function)

33 (1)

3.5

3% (0.3 more points on 0‐10 scale)

9% (W)

not applicable

not significant

silver

Spinal pain (0‐10, none to severe)

33 (1)

5.5

9% (0.9 less points on 0‐10 scale)

16% (I)

not applicable

not significant

silver

Physician global assessment
(0‐5, none to severe)

84 (2)

2.21**

3% (0.15 less points on a 0‐10 scale)

6% (I)

not applicable

not significant

silver

Patient global assessment
(0‐5, none to severe)

84 (2)

2.73**

2% (0.1 more points on a 0‐10 scale)

4% (W)

not applicable

not significant

silver

*based on Gonzalez‐Lopez 2004
**based on Altan 2001

W=worsening
I=improvement

Figuras y tablas -
Table 3. Clinical relevance table ‐ continuous
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Comparison 1. MTX vs No MTX

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Response in the composite index Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

2 BASDAI (VAS‐10 cm, 0=no disease activity, 10=severe disease activity) Show forest plot

2

61

Mean Difference (IV, Random, 95% CI)

0.97 [‐1.22, 3.15]

3 BASFI (score 0‐10, 0=excellent, 10=poor function) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4 Function index (score 0‐40, 0=the best, 40=the worst) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5 Pain in the day (VAS‐10 cm, 0=no pain, 10=severe pain) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6 Pain in the night (VAS‐10 cm, 0=no pain, 10=severe pain) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7 Spinal pain (VAS 10 cm, 0=no pain, 10=severe) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8 BASMI (VAS‐10 cm, 0=severely limited spinal mobility, 10=overall normal) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

9 Spondylitis index (score 0‐10, the more severe the disease, the higher the score) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

10 Enthesis index (score 0‐90, the more severe the disease, the higher the score) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11 Disappearance of peripheral arthritis (event) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12 Patient global assessment (different scales, the more severe the disease, the higher the score) Show forest plot

2

84

Std. Mean Difference (IV, Fixed, 95% CI)

0.12 [‐0.31, 0.55]

13 Physician global assessment (different scales, the more severe the disease, the higher the score) Show forest plot

2

84

Std. Mean Difference (IV, Random, 95% CI)

‐0.14 [‐1.02, 0.75]

14 Physical well‐being (VAS 100 mm, 0=feeling very well, 100=very bad) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

15 Morning stiffness duration (units not specified in trial report, we assumed minutes) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

16 Severity of morning stiffness (VAS 10 cm, 0=no stiffness, 10=severe) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

17 Health assessment questionnaire for spondyloarthropathies (HAQ‐S) (0‐3, 0=no difficulty, 3=unable to do) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

18 CRP (change from baseline) (percent for Altan, ug/ml for Roychowdhury) Show forest plot

2

79

Std. Mean Difference (IV, Fixed, 95% CI)

0.04 [‐0.40, 0.48]

19 ESR (percent change from baseline) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

20 Side effect Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

21 Withdrawal for any reason Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. MTX vs No MTX
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