Patterns of use and dosing of tocilizumab in the treatment of patients with rheumatoid arthritis in routine clinical practice: the ACT-LIFE study.

The aim of the study was to identify and describe the patterns of use of tocilizumab in clinical practice to ensure safety and optimal management of rheumatoid arthritis (RA). This is a 12-month prospective observational study in patients with moderate or severe RA of ≥6 months' duration who have started tocilizumab after failure of at least one previous disease-modifying antirheumatic drug (DMARD) including TNF inhibitors. For some analyses, patients were categorized by the use of tocilizumab as monotherapy or in combination, and by previous use of biological therapy. Overall, 379 were evaluable (84.4 % received tocilizumab after prior biologics and 78.4 % in combination with classic DMARDs). Tocilizumab was discontinued in 68/379 (17.9 %) patients after a median of 6.7 (3.7-10.4) months, mainly due to a lack of efficacy (24/379, 6.3 %) and adverse events (23/379, 6.1 %). Of 131 temporary interruptions of tocilizumab required in 101/379 (26.6 %) patients, 81/131 (61.8 %) were related to adverse events, and in 120/131 (91.6 %) cases, tocilizumab was reintroduced at 8 mg/kg. Thirty-six tocilizumab dose reductions occurred in 34/379 (9 %) patients due to abnormal laboratory values in 20/34 (55.6 %) cases. DAS28-ESR scores decreased from baseline (5.6 ± 1.0) to week 24 (3.0 ± 1.4) and week 52 (2.7 ± 1.3). DAS28 response differed between biologics-naive and biologics-experienced patients, both at weeks 24 and 52. In clinical practice, tocilizumab is effective in RA while retaining the expected safety and tolerability profile. Tocilizumab seems to be more effective for biologics-naive patients than for biologics-experienced patients, while it proves to be similarly effective when used in combination or monotherapy.

Position paper from the Spanish Society of Rheumatology on biosimilar drugs.

A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs.

Systemic lupus erythematosus and thrombotic thrombocytopenia purpura: a refractory case without lupus activity.

The association between systemic lupus erythematosus (SLE) and thrombotic thrombocytopenic purpura (TTP) has been infrequently reported. Usually, patients with TTP have more SLE activity and frequent renal involvement. Here we present a case of TTP associated to low-activity SLE. The absence of renal and major organ involvement increased the difficulty in making the initial diagnosis. ADAMTS13 activity in plasma in this patient was very low, as seen in other similar cases. The evolution of the patient was poor, needing plasma exchanges and immunosuppressive therapy, including the use of rituximab.

[Is the DAS28 Score the Most Adequate Method to Estimate Activity in Rheumatoid Arthritis? Clinimetric Considerations and Simulations Scenarios]. / ¿Es la puntuación DAS28 el método más adecuado para estimar la actividad de la artritis reumatoide? Consideracionens clinimétricas y escenarios de simulación.

INTRODUCTION: The DAS28 score has now consolidated as a fundamental variable for the assessment of rheumatoid arthritis activity and is the main parameter used to establish therapeutic decisions in this disease, including the start and change of biologic therapies. OBJECTIVES: We have studied the clinimetric properties of DAS28, including ceiling and floor effects and its behavior in several clinical scenarios. MATERIAL AND METHOD: Individualized study of the variables included in the DAS28 formula along its possible range. Sensitivity analysis of the results of the DAS28 of 4 variables in four theoretical scenarios corresponding to low (DAS28=2.43), fair (DAS28=4.05), high (DAS28=6.32) or very high (DAS28=8.40) clinical activity. RESULTS: Tender joint count (NAD) and erithrosedimentation rate (ESR) have a weight of 35- 40% each on the total DAS28 score, while swollen join count (SJC) and global health assessed by the patient (GH) only contribute with 15% each. As tender joints weights double than swollen joints, in the simulation models having one swollen joint needed just 3 tender joints to get the DAS28 above the non remission level (DAS28>2.6), while having one tender joint needed 5 swollen joints to be above remission. Given its logarithmic calculation in the DAS28 formula, ESR contribution is much higher in its lower range, and thus small variations of ESR in the normal range can influence decisively in the final DAS28 score. CONCLUSIONS: The asymmetric weight of each component in the complex DAS28 formula must be taken into account when interpreting changes in the DAS28 lower range as they influence the estimation of clinical remission and thus can be relevant when taking therapeutic decisions.