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This section offers news briefs on drug approvals as of August 2008. The U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee has recommended the approval of tocilizumab Actemra from Roche for the treatment of rheumatoid arthritis (RA). FDA rejected the approval of Alprostadil from NexMed Inc. for the treatment of erectile dysfunction based on the results of a 2002 carcinogenicity study in mice. The Medical Products Agency of Sweden has approved the ciprofloxacin ProQuin XR from Depomed and Rottapharm.

The article discusses the results of several studies presented at the joint annual meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP). Etanercept and methotrexate was found to improve the conditions of patients with rheumatoid arthritis (RA). Adalimumab was found to be safe and effective as juvenile RA treatment. A single intra-articular botulinum toxin A injection was noted effective in relieving refractory shoulder pain associated with osteoarthritis.

The millions of people around the world who live day to day with the symptoms of rheumatoid arthritis and their physicians should take note of the results from the GO-AFTER, GO-FORWARD and GO-BEFORE trials, presented at the 2008 European Congress of Rheumatology (ECR) [Paris, France; June 2008]. These multicentre, randomised phase III trials have demonstrated the efficacy and tolerability of golimumab, a next-generation, humanised anti-TNF-α monoclonal antibody, in a wide range of patients with active rheumatoid arthritis. GOAFTER evaluated golimumab in patients who had already been treated with an anti TNF-α therapy, GOFORWARD involved patients already treated with methotrexate, and GO-BEFORE focussed on golimumab's activity in methotrexate-naive patients. Coupled with these findings, a leading advisory company has indicated that, should golimumab get the go ahead from regulatory authorities, it is likely to emerge as a significant player in the rheumatoid arthritis drug market. [ABSTRACT FROM AUTHOR]

The article discusses the results of several studies on COX-2 inhibitors that were presented at the joint annual meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP) held in Boston, Massachusetts in November 2007. Celecoxib was found effective in treating patients with chronic lower back pain in the U.S. Lumiracoxib was found effective than ibuprofen in controlling blood pressure (BP). Lumiracoxib was noted to reduce the incidence of small bowel breaks than naproxen.

The article discusses a study on licofelone, presented at the joint 70th Annual Scientific Meeting of the American College of Rheumatology and the 41st Annual Meeting of the Association of Rheumatology Health Professional. According to data presented at the meeting, licofelone is an effective disease modifying therapy in patients with osteoarthritis of the knee. Licofelone is compared with naproxen, as a disease modifying therapy.

Reveals that celecoxib [Celebrex] significantly reduces the risk of sporadic colorectal adenoma recurrence after polypectomy, with the greatest benefits in patients presenting with advanced neoplasms, according to data from two studies presented at the 97th Annual Meeting of the American Association for Cancer Research. Methodology of the study; Results and discussion of the study.

Presents studies on the efficacy of etanercept, a tumor necrosis factor-alpha antagonist, for treating psoriatic arthritis, which appeared in the March 2005 issue of the "Journal of the American Academy of Dermatology." "Etanercept in Psoriatic Arthritis: Sustained Improvement in Skin and Joint Disease and Inhibition of Radiographic Progressior at 2 Years," by M. Lebwohl et al.; "Preliminary Results of Educate, a Multicenter, Community-Based, Open-label study of the Effect of Etanercept on Skin and Joint Disease in Patients With Psoriatic Arthritis," by A. Gottlieb et al.

The article discusses a pooled analysis of the effectiveness of celecoxib in arthritis patients. The pooled analysis was presented at the 73rd Annual Scientific Meeting of the American College of Gastroenterology. It covered 21 randomised, controlled trials from the Pfizer Corporate Clinical Trials Registry which included data from patients with osteoarthritis.

The article reports on the ability of certolizumab to inhibit joint damage in rheumatoid arthritis (RA) based on clinical trials presented at the European League Against Rheumatism (EULAR) meeting. Certolizumab combined with methotrexate significantly inhibited structural damage progression at weeks 24 and 52 compared with methotrexate alone. Patients who received the combined drugs had decreases from baseline in erosion score, modified Total Sharp Score and joint space narrowing score than those who received placebo.

The article presents information on a study which investigated the adverse effect of the drug celecoxib. According to results from the Celecoxib Cross Trial Safety Analysis, different celecoxib doses and regimens are associated with differences in the risk of cardiovascular events. The researchers note that the data support the recent American Heart Association scientific position statement suggesting that physicians should prescribe the lowest doses of celecoxib possible, especially in higher-risk patients.

The article reports that the British National Institute for Health and Clinical Excellence (NICE) has recommended the drug adalimumab manufactured by Abbott Laboratories in the indication of severe active ankylosing spondylitis (AS). The drug has been previously recommended by NICE for use in active and progressive psoriatic arthritis, and moderate to severe active rheumatoid arthritis.

The article reports on the results of a multicentre phase III study on the long term effectiveness of adalimumab in patients with psoriatic arthritis. It states that 395 patients received 40 milligrams of the drug every other week during the open-label extension trial. It says that the drug resulted in maintanined responses from baseline.

The article reports on the effectiveness of ocrelizumab and methotrexate in the treatment of rheumatoid arthritis (RA) based on a trial. It involves 237 patients who received the combination therapy, ocrelizumab alone and placebo for 72 weeks. The rates of serious adverse effects were found similar between the combination therapy, ocrelizumab and placebo groups. Reduction in C-reactive protein level and low immunogenicity were noted in the combination therapy group.

The article reports on the benefits of ustekinumab to patients with psoriatic arthritis based on a study. It involves 146 patients who received the drug and placebo for 16 weeks. Patients who received ustekinumab had mean decrease from baseline in the Health Assessment Questionnaire disability index. They also had mean decrease from baseline in the Dermatology Life Quality Index.

The article presents the results of a study on the effectiveness of naproxcinod in the treatment of knee osteoarthritis. The study involves 918 patients who were randomized to receive naproxcinod at 375 mg and 750 mg dosages, naproxen at 500 mg dosage and placebo. It notes that naproxcinod doses were associated with smaller mean increases in systolic blood pressure (BP) than placebo. Naproxen was associated with mean increase in systolic BP. Naproxcinod had similar rates of adverse effects with naproxen and placebo.

The article discusses research on which evaluates the efficacy and safety of etoricoxib compared with naproxen in treating patients with osteoarthritis (OA). It references a study by J. Y. Reginster and colleagues in the July 2007 issue of "Annals of the Rheumatic Diseases." The study found that etoricoxib and naproxen both demonstrate long-term efficacy in patients with OA of the knee or hip.

This section offers news briefs on drug approval as of August 2007. An expanded approval of lumiracoxib from Novartis for the treatment of acute and chronic osteoarthritis (OA) was approved by Health Canada. Swiss health authority Swissmedic granted approval of nilotinib from Novartis for the treatment of chronic myeloid leukemia.

The article reports on the increased risk of adverse cardiovascular events associated with rofecoxib based on a Vioxx in Colorectal Cancer Therapy: Definition of Optimal Regime (VICTOR) study by D. J. Kerr et al published in the July 2007 issue of the "New England Journal of Medicine." The study initially hypothesized that rofecoxib will decrease tumor recurrence rates in patients who underwent colorectal cancer surgery. The subjects of the study were randomized to receive rofecoxib or placebo.

The article reports that EMEA has recommended restrictions on piroxicam-containing products due to a risk of GI adverse effects and serious skin reactions. A press release by the agency's Committee for Medicinal Products for Human Use (CHMP) has determined that piroxicam should no longer be used for short-term painful and inflammatory conditions.

The article focuses on several studies presented at the 2007 Annual European Congress of Rheumatology (EULAR). One-year results from a phase II trial suggested the potential of golimumab for the treatment of rheumatoid arthritis (RA). Results from an extension of a randomized phase II study showed that belimumab is associated with durable benefits in patients with systemic lupus erythematosus. Denosumab therapy prevents bone erosion in RA patients according to a study.

The article reports that the combination of prednisolone plus paracetamol (acetaminophen) is similar to indometacin plus paracetamol as treatment for acute gouty arthritis according to a trial conducted by researchers from China and Australia. Patients with acute arthritis were asked to take IM diclofenac plus oral indometacin or oral prednisolone and paracetamol. The prednisolone group had a greater rate of decrease in mean visual analogue scale (VAS) pain scores.

The article focuses on studies on the effectiveness of two drugs in treating arthritis in children presented at the 24th Annual General Meeting of the British Society for Rheumatology (BSR) and the Spring Meeting of the British Health Professionals in Rheumatology (BHPR). The first research demonstrated that adalimumab is efficacious in juvenile rheumatoid arthritis (JRA). The second study found that abatacept is effective for the treatment of juvenile idiopathic arthritis (JIA).

The article discusses the results of a study which shows the benefit of levofloxacin treatment for patients with active rheumatoid arthritis (RA) receiving methotrexate. It references the study "Levofloxacin treatment in patients with rheumatoid arthritis receiving methotrexate," by M. Ogrendik, published in the 'Southern Medical Journal." Enhanced improvement in all endpoints were achieved by patients receiving methotrexate plus levofloxacin.

The article discusses research being done on the effectiveness of tacrolimus in the treatment of refractory rheumatoid arthritis. It references a study by S. Kawai and colleagues, published in the November 2006 issue of the "Journal of Rheumatology." The methodology of the study is described. The adverse effects of tacrolimus are mentioned.

The article discusses research on the cardiorenal effects of celcoxib as compared with the nonsteroidal anti-inflammatory drugs diclofenac and ibuprofen. It references a study by A. Whelton and colleagues published in the October 2006 of "Kidney International." The incidence of clinically important changes in renal function was significantly lower among celecoxib recipients than diclofenac of ibuprofen recipients.

The article discusses research being done on the adverse drug reaction to Arcoxia (etoricoxib). According to the findings of a preliminary drug analyses, Arcoxia appears to be associated with a similar rate of thrombotic cardiovascular events, in patients with arthristis, but a higher rate of discontinuations due to hypertension- and oedema-related adverse events compared with diclofenac.

The article discusses research being done on the adverse drug reaction to cyclooxygenase 2 inhibitors. It references a study by F. Andersohn et al, which appeared in the July 2006 issue of the journal "Stroke." According to the results of a nested case-control study, the use of rofecoxib and etoricoxib, but not of celecoxib, appears to be associated with an increased risk of ischaemic stroke compared with no use.

The article discusses research being done on link between the long-term use of celecoxib or rofecoxib and cardiovascular events. It references a study by S. P. Motsko and colleagues, published in the 2006 issue of "Drug Safety." The methodology of the study is described. A comparison between long-term use of celecoxib, rofecoxib and ibuprofen is presented.

The article reports on the correction made with regard to an analysis in Merck's Adenoma Polyp Prevention on Vioxx study. This correction includes the use of linear time rather than logarithm of time in the test for proportionality of hazards and the results of an overall test of the proportional-hazards assumption for the entire 36-month observation period.

Reports that some cardiologists have claimed that the risk of cardiovascular events associated with Vioxx (rofecoxib) becomes elevated earlier than previously reported. Results from the APPROVe extension study unveiled by Merck.

Discusses research on the off-drug extension of the Adenomatous Polyp Prevention on Vioxx. Reference to a study published in the May 11, 2006 issue of "Media Release"; Findings from follow-up data from day 15 postdiscontinuation of study therapy; Adverse effects of the drug.

Discusses research being done on the efficacy of nitronaproxen over rofecoxib for osteoarthritis of the knee. Reference to a study by T. J. Schnitzer, A. J. Kivitz, R. S. Lipetz, . Sanders and A. Hee, published in the December 2005 issue of "Arthritis and Rheumatism: Arthritis Care and Research"; Indications of the efficacy of nitronaproxen; Incidence of adverse events.

The article discusses research being done on the high rate of Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) with the use of valdecoxib in the U.S. It references a study by L. La Grenade et al in the 2005 issue of "Drug Safety." The incidence of SJS and TEN which resulted from the use of celecoxib, rofecoxib and meloxicam were compared in the study. The of side effects for valdecoxib were higher than that of the background incidence rate.

The article presents the results of an analysis of gastrointestinal (GI) and thromboembolic events in primary care patients who received rofecoxib or celecoxib. Rofecoxib appears to be associated with an increased incidence of symptomatic upper GI events compared with celecoxib, but there seems to be no difference between the two drugs in the incidence of complicated upper GI and thromboembolic events. The researchers analysed data from rofecoxib and celecoxib prescription event monitoring studies.

Presents revisions to the Canadian Celebrex label issued by Pfizer. Result of the use of another COX-2 inhibitor after coronary bypass; Information on the Warnings and Precautions section of the label.

Reports on the results of a study conducted by E. Molden and P. Braathen, in Norway regarding the concurrent use of celecoxib and cytochrome P450 (CYP) 2D6 substrates in Norwegian general practice. Details of the experiment; Most frequently used CYP2D6 substrates; Potential for drug interactions in 50% of cases of celecoxib and concurrent CYP2D6 substrate use.

Discusses research being done on the effectiveness of etoricoxib compared to naproxen in treating ankylosing spondylitis. Reference to a study by D. van der Heijde et al published in the April 2005 issue of "Arthritis and Rheumatism"; Dosage of drugs given to the patients.

Discusses research being done on the effectiveness of nitronaproxen which is similar to naproxen as a treatment for osteoarthritis. Reference to a study by D. McKeith et al, published in the March 2005 issue of the "Annals of the Rheumatic Diseases"; Impact of nitronaproxen on the incidence of peptic ulcers among patients; Incidence of pain among the patients treated with nitronaproxen.

Discusses research being done on the cost-effectiveness of COX-2 specific inhibitors for treating high-risk patients with arthritis from a U.S. Veterans Health Administration perspective. Reference to a study by M. Schaefer et al, published in the January 2005 issue of the "Current Medical Research and Opinion"; Total medical cost in using celecoxib; Difference of treatment cost between rofecoxib recipients and nonsteroidal anti-inflammatory agents.

Presents studies on cyclooxygenase 2. "Majority of Patients Have Discontinued Use of COX-2 Inhibitors," which appeared in the March 9, 2005 issue of the newsletter "Media Release"; "Arthritis Patients Remain Confused About the Safety of Pain Medications and Are Suffering," which appeared in the March 10, 2005 issue of the newsletter "Media Release."

Discusses research being done on the odds of developing nonfatal myocardial infarction in patients exposed to rofecoxib and celecoxib. Reference to a study by S. E. Kimmel et al published in the February 1, 2005 issue of "Annals of Internal Medicine"; Effect of cyclooxygenase-2 inhibitor use on the risk of nonfatal myocardial infarction; Reason for the difference in odds of nonfatal myocardial infarction between rofecoxib and celecoxib.

Discusses research being done on the effectiveness of lumiracoxib in the treatment of osteoarthritis of the knee. Reference to a study by Tannenbaum and colleagues published in the November 2004 issue of the "Annals of the Rheumatic Diseases"; Number of patients included in the study; Comparison between lumiracoxib and celecoxib.

Discusses research being done on the safety profile of celecoxib as used in general practice in England. Reference to a study by Layton and colleagues published in the September 2004 issue of the "European Journal of Clinical Pharmacology"; Reasons for stopping celecoxib treatment; Adverse drug reactions to celecoxib.

Presents information on several researches on drug effectiveness for the treatment of various diseases as of September 2004. Effect of dexamethasone on doxorubicin liposomal-induced erythrodysaesthesia in patients with recurrent gynaecologic malignancies; Comparison of rofecoxib with celecoxib in rate of myocardial infarction risk and cardiac death.

Presents information on a study which determined whether treatment with the cyclooxygenase 2 inhibitors rofecoxib and celecoxib is associated with the risk of new-onset hypertension. Comparison of the relative risk of new-onset hypertension in rofecoxib recipients and celecoxib recipients; Information on the dose or duration relationship between use of either rofecoxib or celecoxib and new-onset hypertension.