What is known and objective Rheumatoid arthritis (RA) is an autoimmune disease characterized primarily by inflammation and pain in the joints. Tofacitinib is an oral drug recently approved for RA treatment; it inhibits Janus protein kinases (JAK) that reduces RA symptoms when conventional DMARDs do not trigger a response. This study aimed to compare the efficacy of biological DMARDs in monotherapy or combined with methotrexate in RA patients and compare the treatments. Methods We reviewed the literature for articles published up to June 2017, evaluating the efficacy and safety of the biological DMARDs indicated for RA in patients with inadequate responses to conventional DMARDs and naïve to biological DMARDs, in similar populations, considering ACR50 as the efficacy variable. The odds ratio (OR) and 95% confidence interval (CI) were calculated for each drug combination, and these parameters were transformed into differences in responses to assess the effectiveness of the alternative medicines. Equivalence therapeutic alternatives (ETA) were ensured to assess the possibility of considering these medications with equivalent efficacy. A network meta‐analysis (NMA) was performed using Bayesian approaches and the fixed‐effects model. Results and discussion Twenty‐seven randomized clinical trials (RCTs) that met the pre‐established criteria were identified. The 95% CI of biological DMARDs was higher than that of placebo without methotrexate, except for certolizumab, golimumab‐m, anakinra‐m and adalimumab monotherapy. These DMARDs performed significantly better than the placebo, except for etanercept, certolizumab, tofacitinib and golimumab. Certolizumab‐m was better than anakinra‐m and adalimumab, and tocilizumab alone or combined with methotrexate was superior to adalimumab. Etanercept‐m yielded a higher difference in responses compared with the other biological DMARDs, which presented more homogeneous responses, except for adalimumab and anakinra‐m, which yielded worse results. None of the biological DMARDs displayed ETA to etanercept‐m; however, they displayed ETA with certolizumab‐m, except for adalimumab and anakinra‐m. What is new and conclusion All biological DMARDs used in combination with methotrexate, except for etanercept, anakinra, certolizumab and tocilizumab without methotrexate, were displayed ETA on using ACR50 at week 24 in patients naïve to biological DMARDs. Etanercept displayed a greater difference in responses, although the high uncertainty of the comparative results prevented the confirmation of the increased efficacy of this drug.

In our clinical experience, more than half of patients do not present a complete response to biologic drugs, or drug loses its efficacy over time. Plasma determinations of drug and anti-drug antibodies levels are an objective tool for optimisation in these patients; however, established therapeutic ranges are not suitable, so the objective of this study was to study these patients and optimise their healthcare. We have made a retrospective, observational study, using data of plasma levels of drugs and anti-drugs antibodies of infliximab, adalimumab or Etanercept, we summarise all data and make a study of sensitivity, specificity, positive and negative predictive value on current therapeutic ranges. We have found a statistically significant association between subtherapeutic levels and therapeutic failure in psoriasis treated with infliximab and adalimumab. New ranges were found with higher sensitivity than the established ones, we propose 2–10 µg/mL therapeutic range for infliximab, 3–11 µg/mL for adalimumab, and 1–7 µg/mL for etanercept. In conclusion, levels of drug and anti-drug antibodies are a decisive tool for predicting therapeutic response. The current therapeutic ranges may have minimum values that are excessively high, owing to which lowering them significantly increases the sensitivity of the test in all cases, and negative predictive value in the case of etanercept. Further prospective studies are needed to prove the usefulness of these new ranges.

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Background and importance The introduction of biological drugs changed the pharmaceutical market, improving patients' prognoses and quality of life. Intravenous MabThera, authorised in January 1998, is the originator of the monoclonal antibody rituximab. In Italy, the regulatory agency approved the first rituximab biosimilar, Truxima, in July 2014, and the second, Rixathon, in December 2017. Aim and objectives The objective was to analyse and compare MabThera and its biosimilars in our region in the period 2017-2019 in terms of regional consumption, costs and adverse drug reactions (ADRs). Material and methods Regional consumption and costs data for rituximab between January and September 2017, 2018 and 2019 were collected and analysed, using Microsoft. ADR reports were extracted from the Adverse Drug Reactions National Report (ADRsNR) and stratified by gravity, gender of the patient and diagnosis.