Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: Results of a two‐year, randomized, double‐blind, placebo‐controlled trial

Article

Author: Jack Mallek ; Jeffrey Felt ; Stephen Hadley ; Lynell Klassen ; Gerald Moore ; P. James Eckhoff ; Robert Leff ; Melvin Churchill ; Kent Blakely ; William Palmer ; Claire Haire ; James R. O'Dell ; Gail Paulsen ; Julie Stoner ; Ana Fernandez ; Paul Waytz ; Steven Wees

AbstractObjectiveTo compare the efficacy of combination therapy with methotrexate (MTX) and hydroxychloroquine (HCQ), MTX and sulfasalazine (SSZ), and MTX, HCQ, and SSZ in patients with rheumatoid arthritis (RA).MethodsRA patients (n = 171) who had not previously been treated with combinations of the study medications were randomized to receive 1 of the 3 treatment combinations in this 2‐year, double‐blind, placebo‐controlled protocol. HCQ was given at a dosage of 200 mg twice a day. The dosage of MTX was accelerated from 7.5 mg/week to 17.5 mg/week in all patients who were not in remission. Similarly, the dosage of SSZ was escalated from 500 mg twice a day to 1 gm twice a day in patients who were not in remission. The primary end point of the study was the percentage of patients who had a 20% response to therapy according to the American College of Rheumatology (ACR) criteria at 2 years.ResultsIntent‐to‐treat analysis revealed that patients receiving the triple combination responded best, with 78% achieving an ACR 20% response at 2 years, compared with 60% of those treated with MTX and HCQ (P = 0.05) and 49% of those treated with MTX and SSZ (P = 0.002). Similar trends were seen for the ACR 50% response, with 55%, 40%, and 29% of patients in the 3 treatment groups, respectively, achieving these results at 2 years (P = 0.005 for the triple combination group versus the MTX and SSZ group). All combination treatments were well‐tolerated. Fourteen patients (evenly distributed among the 3 groups) withdrew from the protocol because of symptoms that were potentially related to the study medication.ConclusionThe triple combination of MTX, SSZ, and HCQ is well‐tolerated, and its efficacy is superior to that of the double combination of MTX and SSZ and is marginally superior to that of the double combination of MTX and HCQ.

Polyurethanes in biomedical applications: promises of the past, present realities and vibrant future

Author: Zdrahala, Richard J.

A review with referencesPolyurethanes, due to their extensive structure/property diversity, are considered as one of the most bio- and blood-compatible materials known today.These materials played a major role in development of many medical devices ranging from catheters to total artificial heart.Properties like durability, fatigue resistance, elasticity, compliance, elastomer character and propensity for healing became attainable via polyurethanes.Furthermore, bulk/surface modification via hydrophilic/hydrophobic balance or by attachments of biol. active species such as anticoagulants, or biorecognizable groups are possible via chem. groups typical for polyurethane structure.These modifications are designed to mediate acceptance and healing of the device or implant.A myriad of processing technologies are used to fabricate functional devices feeling and often behaving like natural tissue.The hydrolytically unstable polyester polyurethanes were replaced by hydrolytically stable but oxidation-sensitive polyether polyols based polyurethanes and their clones containing silicone and other modifying polymeric intermediates.Chronic in vivo instability, however, observed on prolonged implantation, became a major road block for many applications.The present time, represented by utilization of more oxidation resistant polycarbonate polyols soft segments in addition to the above and antioxidants such as Vitamin E, offers materials which can endure in the body for at least three to five years in applications covering cardiovascular devices, artificial organs, tissue replacement and augmentation, coatings and many others.The future is going to expand this field by revisiting a mini-version of RIM technol. and the use of chem. crosslinked systems, in combination with minimally invasive surgical procedures, for delivery of reacting materials to the specific site in the body, polymerizing the mass in-situ, in vivo, producing even more biodurable or biodegradable substrates for long-term implants, cell attachment and proliferation, control of inflammation, healing, etc.A case study of an in vivo restoration of body joints is presented to illustrate the concept of in situ tissue engineering postulated in this paper.

News (Medical) associated with Advanced Bio-Surfaces, Inc.

11 Apr 2007

·www.biospace.com

Advanced Bio-Surfaces, Inc. Receives Award for OrthoGlide(TM) Medial Knee Implant

MINNEAPOLIS, April 11 /PRNewswire/ -- Advanced Bio-Surfaces, Inc., (ABS) an orthopedic implant developer and manufacturer, announced today the OrthoGlide Medial Knee Implant is the recipient of a 2007 Medical Design and Excellence Award (MDEA) in the Implant and Tissue-Replacement Products category. "Advanced Bio-Surfaces is honored to be recognized by MDEA for the OrthoGlide implant. The product's superior engineering and innovative design results in fixation of the implant to the tibial plateau without the use of cement or screws and thus offers a minimally invasive choice for the treatment of medial compartment osteoarthritis of the knee," said Dr. Jeff Felt, Chairman and CEO of Advanced Bio-Surfaces. "ABS is proud of our engineering team's accomplishment in designing and developing a product that will be recognized along side many prestigious past MDEA winners." About Medical Design Excellence Awards The Medical Design Excellence Awards is the only exclusive program that recognizes contributions and advances in the design of medical products. Entries are evaluated on the basis of their design and engineering features and are reviewed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomechanical engineering, human factors, industrial design, medicines and diagnostics. The 2007 MDEA winners will be honored at a ceremony during the Medical Design and Manufacturing (MD&M) East Conference on June 13th, 2007 at the Jacob K. Javits Convention Center in New York City. About Advanced Bio-Surfaces, Inc. ABS is a privately held company dedicated to the development of minimally- invasive and innovative joint repair devices. The company's first commercialized product, the OrthoGlide, is an interpositional arthroplasty for the medial compartment of the knee in patients with moderate to severe osteoarthritis. The company received 510(k) clearance to market from the U.S. Food and Drug Administration (FDA) and CE mark notification from its Notified Body, TUV Product Services (Munich) in February 2006. For additional information contact Robert Siegfried at 952.912.5400. Advanced Bio-Surfaces, Inc. CONTACT: Robert Siegfried, VP, Finance and Administration of AdvancedBio-Surfaces, Inc., +1-952-912-5400 Web site:

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