• Abstract 516: Patient-initiated Review versus Regular Physician-initiated Follow-up in RA
• Abstract 167: Diagnostic and Prognostic Significance of Autoantibodies
• Late Breaking Abstract 18: Clinical and Radiological Outcomes with Different Treatment Stategies in Early RA

Abstract 516 6 year RCT of Patient-initiated Review versus Regular Physician-initiated Follow-up in RA
Hewlett, Kirwan, Blair et al

The delivery of care to patients with RA can be limited by inadequate numbers of rheumatologists and crowded clinic scheduling. Allowing patients to schedule follow-up visits with their rheumatologist only when they deem necessary may serve to free up clinic time and conserve overall cost. Here, Hewlett et al examine the safety of one such strategy in which physician-initiated follow-up visits were replaced with patient-initiated visits.

Methods: Patients with RA of two years duration or greater were randomized into one of two groups. Patients assigned to Group #1 (Direct Access) did not receive routine follow-up appointments. Rather, follow-up was initiated by the patient and organized by a nurse who assessed and set up appointments to either OT/PT or to the rheumatologist within 10 days of request. Follow-up could also be initiated by the patient's primary care physician. Patients assigned to Group #2 (Control) received appointments per-usual by their rheumatologist. PT/OT was prescribed only by the primary rheumatologist. Neither patients nor health care providers were blinded to group assignment.

Indicators of emotional status, psychological instruments (including assessments of patient confidence and satisfaction), grip strength, range of motion at the knee and elbow, number of radiographic erosions on hand radiographs, and laboratory assessment (plasma viscosity, CRP, hemoglobin) were collected at baseline, and after 24, 48 and 72 months.

Results: 209 of 302 screened patients were evenly randomized into the two groups. Groups were evenly matched for baseline disease characteristics (apart from grip strength, which was higher in the Direct Access group. Disease duration was shorter in the Direct Access group, 7 years compared to 10 years in the Control group). 68 patients in the Direct Access group and 52 in the control group completed the study to 72 months. Non-completers tended to have longer disease duration at entry and less ROM at the knee and elbow.

At 72 months of follow-up, scores for disease activity and psychological factors were similar in the two groups except for less deterioration in elbow range of motion in the Direct Access group. However, confidence and satisfaction were maintained in the Direct Access group, but fell 10% in the Control group (p<0.002).

Patients in the Direct Access group had fewer visits over the 72 month study period with a calculated cost savings of 27%.

Conclusions: Patient-initiated direct access to follow-up is as safe as and more cost effective than Physician-initiated routine follow-up.

Editorial Comments: The two and four year data from this study have previously been published. These results would seem to contradict Abstract 515, which advocates tight control of RA through aggressive treatment and monitoring. There are a number of methodological problems, including lack of blinding and high dropout rate of patients with more severe disease, which may seriously biased the results. For example, outcomes may not differ between the two groups because most of the severely affected individuals dropped out, leaving patients with relatively mild disease in the study. We also do not know from the data presented whether important differences in pharmacological treatments existed between the two groups. It is also notable that as many as one third of eligible patients declined participation in the study. The patients who actually entered the study may have differed significantly in disease characteristics, beliefs about disease, etc from those who declined.

Nonetheless, in the current climate with too few rheumatologists, this is an admirable example of forward thinking for a new model for care.

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Abstract 167 The Diagnostic and Prognostic Significance of Autoantibodies in Patients with Very Early Arthritis
Nell, Machold, Eberl, Hiesberger, Hoefler, Smolen and Steiner

In this study, patients with <3 months of arthritis symptoms were followed prospectiviely for at least 6 months. Rheumatoid Factor (RF), anti-CCP, and hnRNP-A2/RA33 antigen (anti-A2/RA33) were measured from sera. 100 patients were diagnosed with RA. Results from this study were reported at Eular. (see results)

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Late Breaking Abstract 18 Clinical and Radiological Outcomes after One-Year Follow-Up of the BeSt Study, a Randomized Trial Comparing Four Different Treatment Strategies in Early Rheumatoid Arthritis (RA)
de Vries-Bouwstra, Goekoop-Ruiterman, Allaart

Early, aggressive treatment with combination therapies such as sulfasalazine with methotrexate and prednisone (see study highlights), and infliximab with methotrexate (see study highlights) have been shown to be more effective than monotherapy in preventing functional decline and radiographic progression in early RA. No head-to-head studies of these treatment strategies exist. Here, de Vries-Bouwstra et al compare two step-up vs. two step-down therapeutic strategies in early RA.

Methods: Patients with active RA of less than 2 years duration and no prior treatment with DMARDs were randomized into one of four groups:

Group 1 Sequential monotherapy starting with methotrexate titrated to 25 mg/wk. If persistent disease activity: discontinue methotrexate and start sulfasalazine, which could be titrated to 2 grams/day. If continued disease activity: discontinue sulfasalazine and start leflunomide 20 mg/day.

Group 2 Step-up therapy starting with methotrexate titrated to 25 mg/wk. If persistent disease activity: add sulfasalazine to methotrexate. Sulfasalazine could be titrated to 2 grams/day. Next step: add hydroxychloroquine 400 mg/day to maximum dose methotrexate and sulfasalazine.

Group 3 Induction with Methotrexate + Sulfasalazine + Prednisone 60mg/day; prednisone titrated down sequentially to 7.5mg/day for improvement in disease activity.

Group 4 Induction with Methotrexate + Infliximab 3mg/kg; Infliximab dose could be increased, decreased, or discontinued based on disease activity score.

Disease activity was evaluated by a blinded clinical assessor at three-month intervals for therapy adjustment. Adjustments in treatment were made if the DAS 44 score was greater than 2.4. At one year, patients had a repeat DAS44 and HAQ assessment.

Radiographs were obtained at one year and evaluated by two independent, blinded assessors. Patients were not blinded to treatment. The primary outcome measure was percentage of patients with DAS 44 < 2.4 at one year.

Results: 508 patients were equally randomized to each of the four groups. No significant differences in baseline characteristics were found between the groups. Data at one year follow are in the table below.

HAQ scores improved more and earlier in Groups 3 and 4 compared to Groups 1 and 2. There was no significant difference in serious adverse events (SAEs) between the groups, although there was a trend towards more SAEs in Group 3 than in the other groups.

Conclusion: Therapy with combination therapy (sulfasalazine, methotrexate, and step-down prednisone) or infliximab + methotrexate is superior to either sequential monotherapy or step-up therapy in achieving a more rapid clinical response at 3 months. These differences are sustained at one year. Less radiographic progression is seen in the same groups at one year.

Editorial Comments: This is the first study to examine head-to-head step-up vs. step-down treatment strategies. The inclusion of a TNF treatment arm adds to its relevance. These results support a more prominent role for induction therapy in early rheumatoid arthritis. Nevertheless, the clinical utility of these strategies require long-term follow-up, both in terms of sustainability of clinical and radiologic effect as well as adverse events. The lack of patient or physician/investigator blinding to treatment is an obvious limitation, despite the imaginable difficulties in blinding the complicated treatments involved.

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