Efficacy and tolerability of adalimumab (humira) in patients with active rheumatoid arthritis

Objective: to evaluate the efficacy and tolerability of adalimumab alone and in combination with basic anti-inflammatory drugs (BAIDs) in
patients with rheumatoid arthritis (RA), by taking into account the specific features of the course of the disease.
Subjects and methods. The study enrolled 30 patients with a verified diagnosis of RA, its high activity by DAS 28, and ineffective previous therapy
with standard BAIDs. At the beginning of the study, 20 (66.7%) patients continued taking BAIDs. According to therapy, the patients were
divided into 3 groups: 1) 10 (33.3%) patients received subcutaneous adalimumab injections only; 2) 12 (40%) took adalimumab+methotrexate
(MT); 3) 8 (26.7%) had adalimumab+leflunomide. The patient groups were matched for age, the duration and activity of RA (by DAS 28),
its X-ray stage and seropositivity.
Nine (37.5%) patients took oral glucocorticoids (GCs) and 25 (83.3%) received non-steroidal anti-inflammatory drugs (NSAIDs). Two (8.3%)
patients had previously been prescribed biological therapies.
Adalimumab was subcutaneously injected every 2 weeks for 24 weeks. The quantitative parameters of articular syndrome and blood and urine
biochemical and clinical analyses were used to evaluate therapeutic effectiveness. The effect of therapy was evaluated by the ACR and EULAR
(DAS 28) criteria. The efficiency of therapy was evaluated 12 and 24 weeks after therapy.
Results. The clinical and laboratory effect of adalimumab was noted in 29 (96.7%) of the 30 patients. All the assessed parameters of articular
syndrome became significantly lower (p<0.001) by week 12 of therapy and to a greater extent by week 24.
Evaluation of the efficiency of adalimumab therapy by the ACR criteria showed that following 12-week therapy, the parameters were decreased
by 20% in 87% of the patients and 50% in 16.7%; after 24 weeks, 23.3, 70 and 96.7% achieved very good (ACR 70), good (ACR 50), and satisfactory
(ACR 20) effects.
Estimation of the time course of changes in the disease activity index (DAS 28) revealed that adalimumab significantly reduced disease activity.
Therapeutic effectiveness was also shown as reduced needs for NSAIDs and GCs. Positive clinical and laboratory changes during adalimumab+
MT combination therapy were also demonstrated to be significantly higher than those during adalimumab monotherapy or adalimumab
+ leflunomide combination therapy.
Conclusion. Adalimumab is an effective disease-modifying biological agent. Its benefits may include the rapid development (on days 4-5 on average) and
long retention (for 6 months or more) of an effect, a good safety profile (adverse reactions occurred only in 16.7% of the patients), and easiness-to-use.

rheumatoid arthritis, basic anti-inflammatory drugs, biologicals, adalimumab

1. <div><p>Насонов Е.Л. Противовоспалительная терапия ревматических болезней. М.: М-СИ- ТИ, 1996;345 c.</p><p>Насонов Е.Л. Фармакотерапия ревматоидного артрита с позиции доказательной медицины: новые рекомендации. РМЖ 2002;10(6):294-302.</p><p>Насонова В.А., Насонов Е.Л. Рациональная фармакотерапия ревматических заболеваний. М.: Литтерра, 2003;800 с.</p><p>Breedveld F.C., Kalden J.R. Appropriate and effective management of rheumatoid arthritis. Ann Rheum Dis 2004;63:627-33.</p><p>Olsen N.J., Stein C.M. New drugs for rheumatoid arthritis. New Engl J Med 2004;350:2167-79.</p><p>ГУ Институт ревматологии РАМН, Ассоциация ревматологов России. Диагностика и лечение ревматоидного артрита. Клинические рекомендации. М., 2004;50 c.</p><p>Welsing P.M., van Gestel A.M., Swinkels H.L. et al. The relationship between disease activity, joint destruction, and functional capacity over the course of rheumatoid arthritis. Arthr Rheum 2001;44:2009-17.</p><p>Furst D., Keystone E., Breedveld F. et al. Updated consensus statement on tumour necrosis factor blocking agent for the treatment of rheumatoid arthritis and other rheumatic diseases. Ann Rheum Dis 2001; 60(Suppl.III): iii 2-5.</p><p>Лукина Г.В., Сигидин Я.А., Позднякова Е.С. и др. Инфликсимаб в тера- пии ревматоидного артрита. Науч-практич ревматол 2007;4:60-5.</p><p>De Vries-Bouwsta J.K., Goekoop-Ruiterman Y., van Zeben D. et al. A comparison of clinical and radiological outcomes of four treatment strategies for early rheumatoid arthritis: results of the BeST trial. Ann Rheum Dis 2004;63(Suppl.1):S58.</p><p>Keystone E.C., Kavanaugh A.F., Sharp J.T. et al. Radiographic, clinical, andfunctional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebocontrolled, 52-week trial. Arthritis Rheum 2004;50:1400-11.</p><p>Breedveld F.C. et al. The PREMIER study: A multicenter, randomized, doubleblind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthr Rheum 2006 Jan;54(1):26-37.</p><p>Weinblatt M.E. et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthr Rheum 2003 Jan;48(1):35-45.</p><p>Keystone E., Kavanaugh A., Fischkoff S. Response to adalimumab in patients with early versus late rheumatoid arthritis (RA). Ann Rheum Dis 2003;62(Suppl.1):170.</p></div><br />