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Malottki K, Barton P, Tsourapas A, et al. Adalimumab, Etanercept, Infliximab, Rituximab and Abatacept for the Treatment of Rheumatoid Arthritis After the Failure of a Tumour Necrosis Factor Inhibitor: A Systematic Review and Economic Evaluation. Southampton (UK): NIHR Journals Library; 2011 Mar. (Health Technology Assessment, No. 15.14.)

Appendix 1Details of key outcomes used in rheumatoid arthritis trials

The Health Assessment Questionnaire

The HAQ now comprises a family of questionnaires designed to assess the functional capacity of patients with musculoskeletal complaints and specifically RA. The most widely used HAQ is derived from the Stanford Health Assessment Questionnaire210 and consists of two or three questions in eight categories:

  • dressing and grooming: dress yourself, including doing shoelaces, and shampooing your hair
  • rising: from an armless chair and in and out of bed
  • eating: being able to cut meat, lift a full cup or glass to mouth, and open a new carton of milk
  • walking: outdoors on flat ground and climb five steps
  • hygiene: wash and dry entire body, take a bath, get on and off the toilet
  • reaching: reach and get down a 5-lb object, bend down and pick up clothing
  • grip: open car doors, open previously unopened jars, turn taps on and off
  • activities: run errands and shop, get in and out of car, do chores.

The score from the most limited activity in each category is obtained. Each category is scored 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do). Use of aids or devices to help with function is taken into account so that need for such assistance automatically scores 2 (unless 3 has been ticked). The maximum score in each of the eight categories is added to give a maximum possible score of 24. This total score may be divided by 8 to give an average value in the range 0–3.

The HAQ has several modifications:39

  • Modified HAQ (MHAQ) is a shortened version of HAQ which uses only one question in each of the eight categories and does not consider the use of aids and devices to assist function. It is simpler to score and has the same range as HAQ (0–3).
  • RA-HAQ is another shortened version of HAQ designed to overcome some of the metric limitations of MHAQ.
  • DHAQ this uses the original eight categories of HAQ, but is based on the most difficult items in each of the categories. Neither the RA-HAQ nor DHAQ have been widely used, unlike MHAQ.

American College for Rheumatology response criteria209

In order to achieve an ACR20 response a 20% improvement in the score for tender joints and a 20% improvement in swollen joints is necessary and 20% improvement in at least three of the following:

  • global disease activity assessed by observer
  • global disease activity assessed by patient
  • patient assessment of pain
  • physical disability score (e.g. HAQ)
  • acute phase response (e.g. ESR or CRP).

Responses may also be defined as ACR50 (50%) or ACR70 (70%) depending on degree of benefit.

The ACR-N is an extension of the ACR response criteria, and is defined as the lowest of the following three values:

  • percentage change in the number of swollen joints
  • percentage change in the number of tender joints
  • the median of the percentage change in the other five measures listed above.

It is thus a continuous variable. For example, an ACR-N score of 38 means an improvement of at least 38% in tender joint counts (TJCs) and swollen joint counts (SJCs) and an improvement of at least 38% in three of the five other parameters.212

DAS

Original DAS

DAS = 0.54(√RAIa) + 0.065(total number of swollen joints out of 44) + 0.33(In ESRb) + 0.0072 (patient general health score where 0 = best, 100 = worst).

(a) RAI refers to a graded score of joint tenderness for 53 joints known as the Ritchie Articular Index and (b) the ESR.

DAS based on 28 joint evaluations

DAS28 – 4 = 0.56(√TJC28) + 0.28(√SJC28) + 0.7ln(ESR) + 0.014(patient general health score where 0 = best, 100 = worst).

Where scores for general health are not available, or not measured, the following formula is used:

DAS28 – 3 = [0.56(√TJC28) + 0.28(√SJC28) + 0.7ln(ESR)]1.08 + 0.16

EULAR response criteria

The EULAR response criteria213 are based on the DAS score. They incorporate both change from baseline and DAS or DAS28 at end point and, based on both, classify patients as good or moderate responders or non-responders (Table 107).

TABLE 107. The EULAR response criteria using DAS and DAS28.

TABLE 107

The EULAR response criteria using DAS and DAS28.

Radiographic assessment methods212

Sharp Score

The simplified Sharp system,215 which evaluates hand and wrist images, assesses 17 areas for erosions and 18 areas for joint space narrowing. Each joint is scored on a 6-point scale as follows: 0 = no erosion; 1 = discrete erosion; 2 = two separate quadrants with erosions or 20%–40% joint involvement; 3 = three 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 greater than 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 5-point scale as follows: 0 = no narrowing; 1 = up to 25% narrowing; 2 = 26%–65% narrowing; 3 = 66%–99% narrowing; 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 fee, 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– 448.216

The 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

Scott et al.217 suggested minor modifications to the scale in order to improve correlation between scorers. It was proposed that grade 1 included erosions and cysts of less than 1 mm diameter and grade included one or more erosions of greater than 1 mm diameter.

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Cover of Adalimumab, Etanercept, Infliximab, Rituximab and Abatacept for the Treatment of Rheumatoid Arthritis After the Failure of a Tumour Necrosis Factor Inhibitor: A Systematic Review and Economic Evaluation
Adalimumab, Etanercept, Infliximab, Rituximab and Abatacept for the Treatment of Rheumatoid Arthritis After the Failure of a Tumour Necrosis Factor Inhibitor: A Systematic Review and Economic Evaluation.
Health Technology Assessment, No. 15.14.
Malottki K, Barton P, Tsourapas A, et al.
Southampton (UK): NIHR Journals Library; 2011 Mar.

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