Comparison of patient-reported and work-related outcomes by week 26 CDC achievement*†
| Patient-reported outcomes in the pooled population | ||||
|---|---|---|---|---|
| CDC achievers (A) | Non-achievers (B) | Difference (C)=(A)–(B) | ||
| N=200 | N=1267 | |||
| Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | p Value | |
| Week 26 | ||||
| VAS-Pain change, N=1463 | −46.91 (−49.83 to −43.98) | −26.88 (−28.04 to −25.72) | −20.03 (−23.18 to −16.88)‡ | <0.0001 |
| n=200 | n=1263 | |||
| FACIT-Fatigue change, N=1452 | 13.29 (12.03 to 14.54) | 7.51 (7.02 to 8.00) | 5.78 (4.42 to 7.13)‡ | <0.0001 |
| n=196 | n=1256 | |||
| SF-36 mental change, N=1086§ | 8.06 (6.45 to 9.66) | 4.98 (4.39 to 5.57) | 3.07 (1.36 to 4.78)‡ | 0.0004 |
| n=131 | n=955 | |||
| SF-36 physical change, N=1086§ | 19.66 (18.13 to 21.19) | 8.91 (8.35 to 9.47) | 10.76 (9.12 to 12.39)‡ | <0.0001 |
| n=131 | n=955 | |||
| Week 52 | ||||
| VAS-Pain change, N=1306 | −45.68 (−48.76 to −42.61) | −28.83 (−30.08 to −27.57) | −16.86 (−20.18 to −13.53)‡ | <0.0001 |
| n=189 | n=1117 | |||
| FACIT-Fatigue change, N=1326 | 12.98 (11.66 to 14.30) | 8.05 (7.52 to 8.57) | 4.93 (3.51 to 6.36)‡ | <0.0001 |
| n=186 | n=1140 | |||
| SF-36 mental change, N=1001§ | 7.26 (5.61 to 8.92) | 5.12 (4.49 to 5.74) | 2.15 (0.38 to 3.91) | 0.0174 |
| n=126 | n=875 | |||
| SF-36 physical change, N=1001§ | 19.37 (17.73 to 21.01) | 10.03 (9.42 to 10.65) | 9.34 (7.57 to 11.10)‡ | <0.0001 |
| n=126 | n=875 | |||
| Work-related outcomes in PREMIER/DE032¶ | ||||
|---|---|---|---|---|
| CDC achievers (A) | Non-achievers (B) | Difference (C)=(A)−(B) | ||
| N=98 | N=563 | |||
| Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | p Value | |
| Week 26 | ||||
| P-HEQ absenteeism among employed patients, N=284 | 9.69 (3.36 to 16.02) | 11.87 (8.82 to 14.93) | −2.19 (−9.22 to 4.85) | 0.5414 |
| n=54 | n=230 | |||
| P-HEQ presenteeism among employed patients, N=278 | −44.23 (−50.30 to −38.17) | −29.94 (−32.84 to −27.04) | −14.30 (−21.03 to −7.56) | <0.0001 |
| n=52 | n=226 | |||
| P-HEQ absenteeism among homemakers, N=182 | 2.30 (−5.88 to 10.48) | 8.51 (5.32 to 11.69) | −6.21 (−14.99 to 2.58) | 0.1650 |
| n=24 | n=158 | |||
| P-HEQ presenteeism among homemakers, N=179 | −52.00 (−61.89 to −42.11) | −31.52 (−35.16 to −27.87) | −20.49 (−31.07 to −9.90) | 0.0002 |
| n=22 | n=157 | |||
| Week 52 | ||||
| P-HEQ absenteeism among employed patients, N=239 | 6.80 (−2.71 to 16.32) | 14.03 (9.09 to 18.98) | −7.23 (−17.96 to 3.51) | 0.1860 |
| n=51 | n=188 | |||
| P-HEQ presenteeism among employed patients, N=237 | −46.29 (−51.49 to −41.10) | −33.65 (−36.33 to −30.97) | −12.64 (−18.50 to −6.78) | <0.0001 |
| n=50 | n=187 | |||
| P-HEQ absenteeism among homemakers, N=154 | 2.94 (−12.62 to 18.49) | 12.97 (6.46 to 19.47) | −10.03 (−26.90 to 6.84) | 0.2420 |
| n=23 | n=131 | |||
| P-HEQ presenteeism among homemakers, N=152 | −51.12 (−60.83 to −41.41) | −34.16 (−38.09 to −30.24) | −16.96 (−27.49 to −6.42) | 0.0018 |
| n=22 | n=130 | |||
| Work-related outcomes in OPTIMA** | ||||
|---|---|---|---|---|
| CDC achievers (A) | Non-achievers (B) | Difference (C)=(A)−(B) | ||
| N=58 | N=255 | |||
| Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | p Value | |
| Week 26 | ||||
| WPAI activity impairment, N=308 | −28.89 (−34.12 to −23.67) | −10.94 (−13.37 to −8.51) | −17.96 (−23.81 to −12.10) | <0.0001 |
| n=58 | n=250 | |||
| WPAI work impairment, N=131 | −25.47 (−32.88 to −18.06) | −7.77 (−12.30 to −3.24) | −17.70 (−26.59 to −8.80) | 0.0001 |
| n=37 | n=94 | |||
| WPAI absenteeism, N=131 | −8.20 (−14.42 to −1.99) | −1.53 (−5.42 to 2.35) | −6.67 (−14.02 to 0.68) | 0.0750 |
| n=37 | n=94 | |||
| WPAI presenteeism, N=144 | −23.19 (−29.04 to −17.34) | −9.41 (−12.99 to −5.82) | −13.78 (−20.82 to −6.74) | 0.0002 |
| n=41 | n=103 | |||
| RA-WIS, N=153 | −5.72 (−7.45 to −3.99) | −2.09 (−3.00 to −1.18) | −3.63 (−5.61 to −1.65) | 0.0004 |
| n=34 | n=119 | |||
| Week 52 | ||||
| WPAI activity impairment, N=284 | −29.85 (−35.69 to −24.01) | −10.60 (−13.37 to −7.84) | −19.24 (−25.81 to −12.68) | <0.0001 |
| n=55 | n=229 | |||
| WPAI work impairment, N=125 | −26.09 (−32.86 to −19.33) | −11.63 (−16.00 to −7.27) | −14.46 (−22.72 to −6.20) | 0.0007 |
| n=38 | n=87 | |||
| WPAI absenteeism, N=125 | −8.93 (−14.10 to −3.76) | −4.56 (−7.96 to −1.15) | −4.37 (−10.59 to 1.84) | 0.1659 |
| n=38 | n=87 | |||
| WPAI presenteeism, N=134 | −24.31 (−30.07 to −18.56) | −9.81 (−13.39 to −6.23) | −14.50 (−21.48 to −7.53) | 0.0001 |
| n=39 | n=95 | |||
| RA-WIS, N=146 | −6.38 (−8.40 to −4.36) | −1.74 (−2.81 to −0.67) | −4.64 (−6.96 to −2.32) | 0.0001 |
| n=33 | n=113 | |||
Boldface indicates statistical significance at the 0.05 level.
*The adjusted analysis compared the mean change from baseline for each outcome by CDC achievement using an analysis of covariance model in which the impact of CDC on change in the outcome was estimated adjusting for the baseline value of the outcome.
†For VAS-Pain, negative change from baseline indicates an improvement in the outcome. For FACIT-Fatigue, SF-36 Mental Health and SF-36 Physical Health, positive change from baseline indicates an improvement in the outcome.
‡Indicates difference exceeds the respective MCID for the outcome.
§SF-36 Physical and Mental Health Component Scores were not measured in OPTIMA.
¶For P-HEQ absenteeism, the mean cumulative number of work days missed from baseline to week 26 and from baseline to week 52 was compared by CDC achievement. For P-HEQ presenteeism, the mean change from baseline to week 26 and from baseline to week 52 was compared by CDC achievement adjusting for the baseline P-HEQ presenteeism.
**For WPAI measures and RA-WIS, the mean change from baseline to week 26 and from baseline to week 52 was compared by CDC achievement adjusting for the baseline value.
CDC, comprehensive disease control; FACIT, Functional Assessment of Chronic Illness Therapy; MCID, minimal clinically important difference; P-HEQ, Patient Health Economic Questionnaire; RA-WIS, Rheumatoid Arthritis-Work Instability Scale; SF-36, Short Form 36; VAS, Visual Analogue Scale; WPAI, Work Productivity and Activity Impairment.