Table 7Summary of results on etanercept (etanercept monotherapy)

Outcome
[if applicable, measurement tool or operationalization]
Result of the meta-analysis or individual studies/result from assessment of relevance (if conducted)
Group differences [95% CI]a,b
(number of studies with results for the benefit assessment/thereof number of studies with outcome-related high risk of bias)
vs. sulfasalazine (MTX-intolerance)vs. MTX (severe active and progressive RA)
Etanercept monotherapy
Remission (DAS 28 [ESR]c < 2.6)OR: 8.60 [0.47; 156.13] (1/1)OR: 14.00 [1.53; 128.49] (1/1)
RA symptoms
 Painful joints (number, relative change [%])d−45.99 [−67.55; −24.43] (1/1)−31.9 [−54.86; −8.96] (1/1)
 Swollen joints (number, relative change [%])d−34.47 [−62.48; −6.46] (1/1)−35.9 [−64.46; −7.34] (1/1)
 Pain (VAS 100 mm [absolute change])d−44.84 [−70.90; −18.78]/−0.87 [−1.40; −0.34]e (1/1)−42.7 [−69.54; −15.85]/ −0.96 [−1.62; −0.31]e (1/1)
 Global assessment of DA by the patient (VAS 100 mm [absolute change])d−34.31 [−51.90; −16.72] / −0.98 [−1.52; −0.45]e (1/1)−38.4 [−64.25; −12.50]/ −0.90 [−1.55; −0.25]e (1/1)
 Assessment of general health by the patient (VAS 100 mm [absolute change])d−37.90 [−58.33; −17.47]/ −0.94 [−1.47; −0.40]e (1/1)−36.4 [−61.88; −10.83]/ −0.86 [−1.51; −0.22]e (1/1)
 Morning stiffness (minutes, absolute change)d−297.51 [−491.96; −103.06] (1/1)−229.7 [−418.63; −40.74] (1/1)
Structural joint changesNot examined
Status of physical functioning
 relative change (HAQ-DI)d−30.71 [−53.96; −7.46]f (1/1)−54.9 [−97.78; −11.92]/ −0.77 [−1.41; −0.13]e (1/1)
 Responder analysis (HAQ-DI)Patients with an improvement of: ≤ -0.22: OR: 4.67 [1.57; 13.89] (1/1)Not examined
Level of social functioningNot examinedNot examined
Health-related quality of lifeNot examinedNot examined
All-cause mortality (deaths)Result not adequately presented (1/1)p > 0.999h (1/1)
ADR
 Pat. with at least 1 SAEp > 0.999h (1/1)p = 0.86h (1/1)
 Study discontinuation due to AEp = 0.88h (1/1)p = 0.70h (1/1)
 Pat. with at least 1 AEp = 0.30h (1/1)p = 0.35h (1/1)
 Pat. with at least 1 serious infectionp > 0.999h (1/1)p > 0.999h (1/1)
 Pat. with at least 1 infectionp = 0.45h (1/1)p = 0.57h (1/1)
a

Mean difference, unless otherwise noted.

b

Results not summarised in meta-analysis because study durations very different.

c

DAS 28 using the inflammatory parameter ESR.

d

Negative effect estimates mean better values under etanercept + MTX.

e

SMD in the form of Hedges' g for assessing the relevance of the statistically significant difference. If the 95% CI did not lie completely below the irrelevance threshold of −0.2 or above the irrelevance threshold of 0.2, an irrelevant effect could not be excluded.

f

Relevance not assessed because a responder analysis was available for the identical study pool.

g

Positive effect estimates mean better values under etanercept + MTX.

h

Solely p-value taken into account in the present benefit assessment.

ADR: adverse drug reactions, AE: adverse event, CI: confidence interval, DA: disease activity, DAS: Disease Activity Score, ESR: erythrocyte sedimentation rate, HAQ-DI: Health Assessment Questionnaire-Disability Index, MTX: methotrexate, OR: odds ratio, Pat.: patients, RA: rheumatoid arthritis, SAE: serious adverse event, SMD: standardized mean difference, VAS: Visual Analogue Scale; vs.: versus

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