A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab A systematic review of the effectiveness of adalimumab
140 Appendix 1 Disease Activity Score (DAS) Original DAS DAS = 0.54(√ ——— RAI) + 0.065(total number of swollen joints out of 44) + 0.33(ln ESR) + 0.0072 (patient general health score where 0=best, 100=worst) where RAI refers to a graded score of joint tenderness for 53 joints, known as the Ritchie Articular Index. DAS based on 28 joint evaluations DAS 28-4 = 0.56(√ ——— TJC28 — ) + 0.28(√ ——— SJC28 — ) + 0.7ln(ESR) + 0.014 (patient general health score where 0=best, 100=worst) where TJC is tender joint count and SJC is swollen joint count. Where scores for general health are not available, or not measured, the following formula is used: DAS 28-3 = [0.56(√ ——— TJC28 — ) + 0.28(√ ——— SJC28 — ) + 0.7ln(ESR)]1.08 + 0.16 Radiographic assessment methods 209 Sharp score The simplified Sharp system, 210 which evaluates hand and wrist images, assesses 17 areas for erosions and 18 areas for joint space narrowing. Each joint is scored on a six-point scale as follows: 0 = no erosion; 1 = discrete erosion; 2 = two separate quadrants with erosions or 20–40% joint involvement; 3 = 3 separate quadrants with erosions or 41–60% joint involvement; 4 = all four quadrants with joint erosion or 61–80% joint involvement; and 5 = extensive destruction with over 80% joint involvement. The range of erosion scores for a patient with two hands and wrists is 0–170. For joint space narrowing each joint is scored using a five-point scale as follows: 0 = no narrowing; 1 = up to 25% narrowing; 2 = 26–65% narrowing; 3 = 66–99% narrowing; and 4 = complete narrowing. The range for joint space narrowing is therefore 0–144. This gives a total joint score in the range 0–314. Van der Heijde modified Sharp score In this case 16 joints are assessed in each hand and wrist and six joints in each foot. Erosions are scored 0–5 and depending on the affected surface area and 0–10 in the feet, yielding possible erosion scores of 0–160 for hands/wrists and 0–120 for feet (total 0–280). Joint space narrowing is assessed in 15 joints for each hand/wrist and six joints in each foot on a scale of 0–4. The range of possible joint space narrowing scores is in the range 0–168. This yields a possible total score in the range 0–448. 211 Larsen score In this method standard films are used to classify each joint into one of six possible categories (0 = normal, 5 = severely damaged). Any joint may be scored, but the focus is on hands and feet. In the hands each proximal interphalangeal joint and each metacarpophalangeal joint scores 0–5; each wrist joint scores 0–25 (the basic score is multiplied by 5): this gives a maximum score of 150 for two hands and wrists. In the feet each metatarsophalangeal joint is scored 0–5, giving a total score of 50 for two feet. This yields a possible total score in the range 0–200. Scott-modified Larsen 212 Scott and colleagues suggested minor modifications to the scale to improve correlation between scorers. It was proposed that grade 1 included erosions and cysts of less than 1 mm diameter and grade 2 included one or more erosions of more than 1 mm diameter.
Cochrane Library (CENTRAL) 2005 Issue 1 #1 rheumatoid NEXT arthritis in All Fields in all products #2 MeSH descriptor Arthritis, Rheumatoid, this term only in MeSH products #3 (#1 OR #2) #4 "tumor necrosis factor*" in All Fields in all products #5 "tumour necrosis factor*" in All Fields in all products #6 MeSH descriptor Receptors, Tumor Necrosis Factor, this term only in MeSH products #7 "anti tnf" in All Fields in all products #8 antitnf in All Fields in all products #9 infliximab in All Fields in all products #10 remicade in All Fields in all products #11 enbrel in All Fields in all products #12 etanercept in All Fields in all products #13 adalimumab in All Fields in all products #14 humira in All Fields in all products #15 (#4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14) #16 (#3 AND #15) Ovid MEDLINE(R) 1966 to February week 2 2005 1 arthritis rheumatoid/ 2 tumo?r necrosis factor.mp. 3 exp receptors tumor necrosis factor/ 4 anti TNF.mp. 5 infliximab.mp. 6 remicade.mp. 7 enbrel.mp. 8 etanercept.mp. 9 or/2-8 10 rheumatoid arthritis.mp. 11 1 or 10 12 9 and 11 13 randomized controlled trial.pt. 14 controlled clinical trial.pt. 15 randomized controlled trials.sh. 16 random allocation.sh. 17 double blind method.sh. 18 single blind method.sh. Appendix 2 Health Technology Assessment 2006; Vol. 10: No. 42 Searches: clinical effectiveness © Queen’s Printer and Controller of HMSO 2006. All rights reserved. 19 or/13-18 20 (animals not human).sh. 21 19 not 20 22 clinical trial.pt. 23 exp clinical trials/ 24 (clin$ adj25 trial$).ti,ab. 25 ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 26 placebo$.ti,ab. 27 random$.ti,ab. 28 placebos.sh. 29 research design.sh. 30 or/22-29 31 30 not 20 32 31 not 21 33 21 or 32 34 12 and 33 35 limit 34 to yr=2001 - 2005 36 adalimumab.mp. 37 humira.mp. 38 or/36-37 39 1 and 38 and 33 40 35 or 39 EMBASE (Ovid) 1980 to week 8 2005 1 arthritis rheumatoid/ 2 tumo?r necrosis factor.mp. 3 exp receptors tumor necrosis factor/ 4 anti TNF.mp. 5 infliximab.mp. 6 remicade.mp. 7 enbrel.mp. 8 etanercept.mp. 9 or/2-8 10 rheumatoid arthritis.mp. 11 1 or 10 12 9 and 11 13 adalimumab.mp. 14 humira.mp. 15 or/13-14 16 randomized controlled trial/ 17 exp clinical trial/ 18 exp controlled study/ 19 double blind procedure/ 20 randomization/ 21 placebo/ 141
- Page 105 and 106: TABLE 34 Basic structure of the mod
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140<br />
Appendix 1<br />
Disease Activity Score (DAS)<br />
Original DAS<br />
DAS = 0.54(√ ———<br />
RAI) + 0.065(total number <strong>of</strong><br />
swollen joints out <strong>of</strong> 44) + 0.33(ln ESR)<br />
+ 0.0072 (patient general health score<br />
where 0=best, 100=worst)<br />
where RAI refers to a graded score <strong>of</strong> joint<br />
tenderness for 53 joints, known as <strong>the</strong> Ritchie<br />
Articular Index.<br />
DAS based on 28 joint evaluations<br />
DAS 28-4 = 0.56(√ ———<br />
TJC28 — ) + 0.28(√ ———<br />
SJC28 — ) +<br />
0.7ln(ESR) + 0.014 (patient<br />
general health score where 0=best,<br />
100=worst)<br />
where TJC is tender joint count and SJC is swollen<br />
joint count. Where scores for general health are<br />
not available, or not measured, <strong>the</strong> following<br />
formula is used:<br />
DAS 28-3 = [0.56(√ ———<br />
TJC28 — ) + 0.28(√ ———<br />
SJC28 — ) +<br />
0.7ln(ESR)]1.08 + 0.16<br />
Radiographic assessment<br />
methods 209<br />
Sharp score<br />
The simplified Sharp system, 210 which evaluates<br />
hand and wrist images, assesses 17 areas for<br />
erosions and 18 areas for joint space narrowing.<br />
Each joint is scored on a six-point scale as follows:<br />
0 = no erosion; 1 = discrete erosion; 2 = two<br />
separate quadrants with erosions or 20–40% joint<br />
involvement; 3 = 3 separate quadrants with<br />
erosions or 41–60% joint involvement; 4 = all four<br />
quadrants with joint erosion or 61–80% joint<br />
involvement; and 5 = extensive destruction with<br />
over 80% joint involvement. The range <strong>of</strong> erosion<br />
scores for a patient with two hands and wrists is<br />
0–170. For joint space narrowing each joint is<br />
scored using a five-point scale as follows: 0 = no<br />
narrowing; 1 = up to 25% narrowing; 2 = 26–65%<br />
narrowing; 3 = 66–99% narrowing; and 4 =<br />
complete narrowing. The range for joint space<br />
narrowing is <strong>the</strong>refore 0–144. This gives a total<br />
joint score in <strong>the</strong> range 0–314.<br />
Van der Heijde modified Sharp score<br />
In this case 16 joints are assessed in each hand<br />
and wrist and six joints in each foot. Erosions are<br />
scored 0–5 and depending on <strong>the</strong> affected surface<br />
area and 0–10 in <strong>the</strong> feet, yielding possible<br />
erosion scores <strong>of</strong> 0–160 for hands/wrists and 0–120<br />
for feet (total 0–280). Joint space narrowing is<br />
assessed in 15 joints for each hand/wrist and six<br />
joints in each foot on a scale <strong>of</strong> 0–4. The range <strong>of</strong><br />
possible joint space narrowing scores is in <strong>the</strong><br />
range 0–168. This yields a possible total score in<br />
<strong>the</strong> range 0–448. 211<br />
Larsen score<br />
In this method standard films are used to classify<br />
each joint into one <strong>of</strong> six possible categories (0 =<br />
normal, 5 = severely damaged). Any joint may be<br />
scored, but <strong>the</strong> focus is on hands and feet. In <strong>the</strong><br />
hands each proximal interphalangeal joint and<br />
each metacarpophalangeal joint scores 0–5; each<br />
wrist joint scores 0–25 (<strong>the</strong> basic score is<br />
multiplied by 5): this gives a maximum score <strong>of</strong><br />
150 for two hands and wrists. In <strong>the</strong> feet each<br />
metatarsophalangeal joint is scored 0–5, giving a<br />
total score <strong>of</strong> 50 for two feet. This yields a possible<br />
total score in <strong>the</strong> range 0–200.<br />
Scott-modified Larsen 212<br />
Scott and colleagues suggested minor<br />
modifications to <strong>the</strong> scale to improve correlation<br />
between scorers. It was proposed that grade 1<br />
included erosions and cysts <strong>of</strong> less than 1 mm<br />
diameter and grade 2 included one or more<br />
erosions <strong>of</strong> more than 1 mm diameter.