Randomized Trial Confirms Value of Tofacitinib in RA


Tofacitinib proves a powerful adjunct to methotrexate (but that DMARD only) in a new clinical trial of rheumatoid arthritis. Also in the nonspecialty journals: Shoe wedges for OA, and when to order ANA tests.

Last week's articles on rheumatology topics in the major non-rheumatology journals

Tofacitinib in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: A Randomized TrialAnn Intern Med, August 20, 2013

This randomized trial was designed to evaluate the efficacy and safety of tofacitinib added to nonbiologic disease-modifying anti-rheumatic drugs (DMARDs), but the only DMARD with statistical power was methotrexate. Results were consistent with previous studies. There were three primary endpoints. In 792 patients with active RA despite methotrexate (77.2%) and other DMARDs, over half the patients in the tofacitinib group reached American College of Rheumatology 20% improvement (ACR20), compared to 31% in the placebo group after six months. After six months, 12.5% in the high-dose group, and 8.5% in the low dose group, reached Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]), compared to 2.6% in the placebo group. The reduction in the Health Assessment Questionnaire Disability Index (HAQ-DI) with tofacitinib was about twice the minimum clinically important difference after three months, but was barely significant in the placebo group. (HAQ-DI responds early to treatment.) Patients assigned to placebo were switched to tofacitinib after three months or six months, and followed for one year. The most common adverse events were upper respiratory tract infections. Four opportunistic infections and one death by respiratory failure were considered treatment-related.

Lateral Wedge Insoles as a Conservative Treatment for Pain in Patients With Medial Knee Osteoarthritis: A Meta-analysisJAMA, August 21, 2013

A meta-analysis concludes that lateral wedges do not reduce pain in medial knee osteoarthritis. Randomized trials, systematic reviews and meta-analyses have found a statistically significant association between the use of lateral wedges and reduction in pain. However, as the trials become better designed, and the analysis becomes more rigorous, the effect becomes weaker. Guidelines of different organizations have no consensus. Some guidelines acknowledge the weak evidence, but conclude that given the low cost and risk, lateral wedges may be worth trying. This meta-analysis includes 12 trials of lateral wedge treatment. The pooled standardized mean difference suggested an effect of two points on the 20-point Western Ontario and McMaster Universities Arthritis Index pain scale. But larger trials with a lower risk of bias showed lower effect. Randomized trials comparing insoles to no insoles may be subject to patient bias. When these studies were restricted to those using a neutral insole comparator, they no longer showed a significant or clinically important association.

Case 26-2013 - A 46-Year-Old Woman with Muscle Pain and SwellingN Engl J Med, August 22, 2013

Muscle Pain and SwellingNow@NEJM, August 23, 2013

The patient in this case study presented with symptoms of an atypical myositis: asymmetrical muscle pain and swelling in the proximal limbs. Over the course of two weeks, she developed symptoms more typical of myositis: symmetrical muscle pain and weakness, weakness in her neck, difficulty holding up her head, difficulty swallowing, garbled speech, and double vision. The weakness also progressed to the distal limbs. Meanwhile, radiology showed a 9 cm x 9 cm x 12.4 cm soft-tissue opaque mass, on the right anterior mediastinum, compressing the right atrium, which raised suspicion of a thyoma causing a paraneoplastic syndrome. After a trial of pyridostigmine and a biopsy, she was diagnosed with inflammatory myopathy and myasthenia gravis associated with thyoma. The mass was removed, and she was treated with glucuocorticoids, after which both drugs  were tapered and discontinued. The prognosis is excellent. The patient, a journalist, was present at the conference and described her experience.

Rational Testing: When to order an antinuclear antibody testBMJ, August 21, 2013

This review intended for primary care practitioners in the UK emphasizes the clinical assessment that should be done before ordering an antinuclear antibody test. Because of the low specificity, “It is important to reserve testing for antinuclear antibody (and extractable nuclear antigens) to patients for whom there is a high pre-test suspicion of systemic autoimmune disease, and to avoid using it as a screening tool in patients complaining of fatigue and generalized musculoskeletal pain,” says the review. It is important to indicate the diseases being considered, it adds, rather than simply ordering an “autoantibody profile.” The authors give checklists of features and symptoms of autoimmune rheumatic diseases and systemic lupus erythematosus.In patients with sciatica, MRI at 1 year did not differentiate between a favorable or unfavorable outcomeAnn Intern Med, August 20, 2013
This review of el Barzouhi’s study in the New England Journal of Medicinereminds internists that MRI does not enhance clinical decisions for patients with sciatica. Its value in this situation is limited to assisting surgeons in planning operative procedures for those already been selected for surgery.

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