Laboratorios Gebro Pharma SA

To compare the efficacy and safety of a once-daily prolonged release (PR) pregabalin formulation to pregabalin immediate release (IR) in patients with diabetic peripheral neuropathy (DPN).

This was a non-inferiority, randomized, double-blind, double-dummy, multiple-dose, multicenter, active and placebo controlled, three-arm, parallel study. Patients were randomly assigned in a 1:1:1 ratio to receive pregabalin PR tablet, pregabalin IR hard capsule (Lyrica) or placebo at an optimized dose based on individual subject's response and tolerability for 13 weeks. The primary efficacy outcome was the change in the mean weekly pain score from baseline to end of treatment.

Overall, 453 patients were randomized. In the per protocol (PP) analysis set, the least square mean (LSM) difference between test and reference treatment for the change in weekly pain score from baseline to end of treatment was 0.06 (95% CI: -0.28, 0.41, p = 0.7121), indicating that pregabalin PR was non-inferior to pregabalin IR. In the Full Analysis Set (FAS), the LSM of change in mean weekly pain score from baseline to end of treatment for test, reference, and placebo groups were -3.43, -3.49, and -3.04, respectively. Test and reference products were superior to placebo (p = 0.0158 and 0.0047, respectively).

The efficacy and safety of pregabalin PR was comparable to pregabalin IR for the treatment of pain in patients with DPN.

We aimed to develop recommendations for the management of methotrexate (MTX) when considering the combination with biological (b) or targeted synthetic (ts) disease modifying drugs (DMARDs) in rheumatoid arthritis (RA).

Eleven experts on RA were selected. Two coordinators formulated 13 questions about the combination therapy of MTX with bDMARDs or tsDMARDs. A systematic review was conducted to answer the questions. Inclusion and exclusion criteria were established as well as the search strategies (Medline, Embase and the Cochrane Library were searched up to January 2019). Two reviewers selected the articles and collected data. Simultaneously, EULAR and ACR meeting abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation was established using the Oxford Center for Evidence Based Medicine and the level of agreement with a Delphi. Agreement was established if at least 80% of the experts voted 'yes' (yes/no).

The systematic review retrieved 513 citations of which 61 were finally included. A total of 10 recommendations were generated, voted and accepted. The level of agreement was very high in all of them and it was achieved in the first Delphi round. Final recommendations cover aspects such as the optimal MTX dosage, tapering strategy or patients' risk management.

This document is intended to help clinicians solve usual clinical questions and facilitate decision making when treating RA patients with MTX in combination with bDMARDs or tsDMARDs.

We aimed to develop recommendations for the management of methotrexate (MTX) when considering the combination with biological (b) or targeted synthetic (ts) disease modifying drugs (DMARDs) in rheumatoid arthritis (RA).

Eleven experts on RA were selected. Two coordinators formulated 13 questions about the combination therapy of MTX with bDMARDs or tsDMARDs. A systematic review was conducted to answer the questions. Inclusion and exclusion criteria were established as well as the search strategies (Medline, Embase and the Cochrane Library were searched up to January 2019). Two reviewers selected the articles and collected data. Simultaneously, EULAR and ACR meeting abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation was established using the Oxford Center for Evidence Based Medicine and the level of agreement with a Delphi. Agreement was established if at least 80% of the experts voted 'yes' (yes/no).

The systematic review retrieved 513 citations of which 61 were finally included. A total of 10 recommendations were generated, voted and accepted. The level of agreement was very high in all of them and it was achieved in the first Delphi round. Final recommendations cover aspects such as the optimal MTX dosage, tapering strategy or patients' risk management.

This document is intended to help clinicians solve usual clinical questions and facilitate decision making when treating RA patients with MTX in combination with bDMARDs or tsDMARDs.