In a historic development, pregabalin (Lyrica, Pfizer) recently became the first drug to gain an FDA-approved indication for the treatment of fibromyalgia, a chronic illness that reportedly affects an estimated three to six million people in the United States. Kim Dupree-Jones, PhD, RN, FNP, says the new fibromyalgia indication “will help raise awareness of the reality of fibromyalgia” and encourage more providers to consider treatment options for the chronic illness.

A recent study revealed that 85 percent of fibromyalgia patients receiving daily pregabalin had a 50 percent or greater reduction in pain at six weeks.

“There is a severe lack of providers who know how to diagnose and treat fibromyalgia,” explains Dr. Jones, an Associate Professor at the Schools of Nursing and Medicine at Oregon Health and Science University in Portland, Ore. “… Unfortunately, providers who do not specialize in fibromyalgia may not have understood that Lyrica treats fibromyalgia pain, fatigue, disturbed sleep and, to some extent, mood.”

Data from a recent 14-week study of pregabalin in 745 patients with fibromyalgia were presented at the American Academy of Neurology annual conference in May. Researchers tested three different dosing regimens of pregabalin — 600 mg/day, 450 mg/day and 300 mg/day — against a placebo. According to the study findings, 30 percent of patients taking the 600 mg/day of pregabalin, 27 percent of the 450 mg/day group and 24 percent of the 300 mg/day group noted a 50 percent or greater reduction in fibromyalgia pain. In comparison, 15 percent of the placebo group had a 50 percent or greater reduction in fibromyalgia pain.

Results from another study of 1,051 patients with fibromyalgia were recently presented at the annual meeting of the American Psychiatric Association. According to the study, 85 percent of patients receiving daily pregabalin (with doses ranging from 300 mg/day to 600 mg/day) had a 50 percent or greater reduction in pain at six weeks. For the second phase of the study, half of the patients who responded to pregabalin continued to receive the medication. The other half was switched to a placebo. At 26 weeks, greater than 60 percent of those taking pregabalin had continued pain relief whereas 32 percent of the placebo group had continued pain relief. Study authors also reported that patients taking pregabalin slept better as well.

“I am likely to use pregabalin early in therapy for patients with fibromyalgia,” notes Charles Moxin, PA-C, the President of the Association of Family Practice Physicians. “Fibromyalgia is often treated with analgesics as well as muscle relaxants and antidepressants. With the positive responses of decreased pain and increased ability to sleep while patients are taking pregabalin, it is possible that other medications may be decreased or eliminated, resulting in decreased polypharmacy.”

Dr. Jones, who maintains a weekly level V referral practice in diagnosing and treating fibromyalgia, concurs. In her experience using the drug off-label to treat patients with the illness, Dr. Jones has found that adjunctive use of pregabalin has allowed her to reduce the total opioid dose in “many of my patients.” Accordingly, she says there are less opioid side effects such as constipation and “fibro-fog.” In her clinical experience, she adds that pregabalin is also adequate for treating mild sleep disruption in patients with fibromyalgia.

“Lyrica has minimal drug-to-drug interactions so I am comfortable giving Lyrica in conjunction with sleep medications like short acting hypnotics and benzodiazepines as Lyrica has no effect at the GABA receptor,” adds Dr. Jones, who is a principal investigator on multiple fibromyalgia research grants.

Moxin and Dr. Jones have noticed some side effects with pregabalin, which was previously approved for the treatment of diabetic peripheral neuropathy and posttherpetic neuralgia. Moxin cites dry mouth and dizziness. They both note initial fatigue but say it resolves after a couple of weeks. Dr. Jones says a small percentage of patients have weight gain but in these cases, she will either lower the dose or possibly cease using the medication.

Arthritis And Work: What Recent Studies Reveal
By Aaron Becker, Associate Editor

Just how significant an impact does arthritis have on the lives of those with the disease? Those who suffer from arthritis spend and lose a significant amount of money managing their disease and enduring its work-related consequences, according to two recent studies.

A recent study, published in Arthritis and Rheumatism, notes that in 2003, patients with arthritis and other rheumatic conditions spent an average of $1,752 on medical care expenses and working adults with arthritis earned an average of $3,613 per year less than those without arthritis. A separate study in Arthritis Care and Research reports that work limitations affect one-third of working-aged adults with diagnosed arthritis.

The authors of the Arthritis Care And Research study note that people tend to minimize their arthritis problems and may not even discuss them with clinicians. Frontline clinicians such as physician assistants (PAs) and nurse practitioners (NPs) are “ideally positioned to solicit information” from their patients regarding the impact of arthritis on their jobs, according to the study’s lead author Kristina A. Theis, MPH and her co-authors.

“If a patient reports any arthritis-attributable activity limitation, he or she is nine times more likely to have an arthritis-attributable work limitation,” point out the study authors. They say this is a helpful screen for work limitation.

Working adults with arthritis earn an average of $3,613 less per year than those without arthritis, according to a recent study.

In addition to encouraging patients to open up about the impact of arthritis on their jobs, the researchers say NPs and PAs can play a valuable role in emphasizing physical activity, maintaining a healthy weight and offering resources for improved self-management.

Getting Specifics On The Work Limitation Interestingly, Theis and her co-authors did not find that arthritis pain in particular joints such as the knee or fingers was more associated with work limitations than pain in other areas.

“The nationally representative nature of our study population demonstrates that arthritis has a considerable and widespread effect on work limitation independent of joint pain site,” note the study authors.

That said, Ellen D. Feld, MD, an Associate Professor in the Physician Assistant program at Drexel University, says it is important to determine just how a patient’s condition limits his or her work activities.

For example, Dr. Feld says those with hand function limitations may have difficulty with a variety of work activities, ranging from heavy lifting to keyboard use. People with knee and hip arthritis may struggle with lower extremity function, according to Dr. Feld. She notes this can be particularly problematic for those with more physically demanding job requirements.

“The person with severe knee arthritis may be able to sit at a desk all day but may not be able to do a job that involves lifting, climbing, walking or even standing for long periods,” notes Dr. Feld.

Once a particular limitation has been specified, it makes it easier for an employer to make an appropriate accommodation, according to Dr. Feld and the study authors. While most employers want to do the right thing when it comes to accommodations, Dr. Feld says bottom-line concerns also factor into the picture.

“Employers are also more receptive to making accommodations if they are not extensive or expensive,” notes Dr. Feld.

Working With RA: Does Combination Therapy Help?
By Aaron Becker, Associate Editor

In intriguing studies recently presented at the European League Against Rheumatism (EULAR) conference, researchers found that the combination of adalimumab (Humira, Abbott) and methotrexate enabled people with rheumatoid arthritis (RA) to work longer and more effectively than those treated with methotrexate alone.

The Prevention Of Work Disability (PROWD) study, a 56-week prospective, multicenter, randomized trial, examined 148 patients with early RA. Study authors found that significantly more patients on methotrexate alone experienced job loss (40 percent) than those taking a combination of adalimumab and methotrexate (19 percent).

Another two-year study suggested that a combination of adalimumab and methotrexate significantly improved the ability of patients with early RA to perform their job responsibilities and those studied had fewer missed work days than those who were treated with methotrexate alone.

Nathan Wei, MD, says RA is a “tremendous problem” when it comes to work disability as the disease can affect multiple joints. He adds that systemic ramifications, including anemia, eye involvement and lung involvement, can also adversely affect a person’s ability to work.

He agrees that early use of combination therapy is critical to facilitating a return to work and improved, long-term outcomes in those with RA.

“Patients who are not treated aggressively (within the critical three-month window) early in the disease are at marked risk for developing radiographic damage, which correlates closely with disability,” explains Dr. Wei, the Clinical Director of the Arthritis and Osteoporosis Center in Frederick, Md.

“… In order to get a patient back into the workforce, it is critical to treat aggressively with a combination of methotrexate and a biologic like adalimumab early. If this is done, a patient who has been unable to work can usually get back to work. More importantly, his or her chance of long-term disability is markedly reduced as well.”

Study Shows Long-Term Safety Of Etanercept For JRA
By Aaron Becker, Associate Editor

For clinicians looking for a treatment option for juvenile rheumatoid arthritis (JRA) that has a strong safety profile, they may want to consider study results that were recently presented at the aforementioned EULAR conference. The recently completed long-term study revealed that the overall rate of serious adverse events did not increase with long-term use of etanercept (Enbrel, Amgen/Wyeth) in patients with JRA. Researchers reported no deaths, lymphomas or other malignancies, tuberculosis or other opportunistic infections.

When it comes to treating children with juvenile rheumatoid arthritis, etanercept has “a very good safety profile,” according to Andreas Reiff, MD.

According to the study, 61 percent of the patients had four years of continuous treatment. Thirty-eight percent of the patients studied began an eighth year of continuous treatment with etanercept and maintained a similar safety profile.

Andreas Reiff, MD, the lead author of the study, says the long-term study findings show that etanercept has “a very good safety profile.” He adds that out of the 26 patients who continued into the eighth year of treatment, only one experienced a serious adverse event.

Dr. Reiff notes he often gets referrals for children with JRA who are already in the late stage of the disease.

“Most of them have had disease activity for at least a year,” explains Dr. Reiff, the head of Rheumatology and Rehabilitation at the Los Angeles Children’s Hospital. “If I see them that late, I would like to use (etanercept) as early as possible. The earlier we use it, the better the outcome for these patients.”

In regard to contraindications with etanercept in patients with moderate to severe JRA, Dr. Reiff says clinicians should be wary of acute, active or chronic infection; a history of allergy to a TNF-inhibitor; or a history of active tuberculosis.

Abatacept For JIA: What A New Study Shows
By Aaron Becker, Associate Editor

In a recent study, researchers found that re-introducing abatacept in patients with juvenile idiopathic arthritis (JIA) who responded to it previously restored the patients to prior ACR Pediatric 30, 50, 70 and 90 responses achieved with the medication.

The study findings, which were recently presented at the aforementioned EULAR conference, were drawn from an open-label extension of a previous study that assessed the benefits of abatacept (Orencia, Bristol-Myers Squibb) in treating JIA Edward H. Giannini, MSc, DrPH, a co-author of the study, says findings such as these are helpful in informing practitioners who seek to regain control over JIA if the disease flares after a patient has discontinued using a given medication.

When it comes to using biologic therapies for JIA, Dr. Giannini says clinicians prefer to stop using these medications after a patient has shown a favorable response for about a year. He attributes this to concerns over cost and the possibility of adverse events developing with more long-term use. However, in his clinical experience, Dr. Giannini says reinstituting some medications does not always “recapture control” over the disease.

In this regard, Dr. Giannini says abatacept could prove to be a viable alternative option for JIA in the future.

“A substantial number of patients will fail to respond to approved drugs such as etanercept (Enbrel, Wyeth). Alternatives are needed and are frequently written off-label,” says Dr. Giannini, a Professor of Pediatrics in the Division of Rheumatology at the Cincinnati Children’s Hospital Medical Center in Cincinnati.

“… Etanercept remains the first biological drug of choice for JIA. If abatacept receives an FDA-approved indication for use in JIA and longer-term safety data show that there are few toxicity worries, that could change.”

The study also showed that re-introduction of abatacept was not associated with infusion reactions or untoward safety findings.

Dr. Giannini praises the efficacy and short-term safety profile of abatacept for JIA, but notes that more long-term safety data is needed.

Zoledronic Acid: A Better Option For Osteoporosis?
By Aaron Becker, Associate Editor

There may be a new agent on the horizon that could have a significant impact in reducing fracture risks in postmenopausal women with osteoporosis.

Researchers recently completed a three-year, double-blind, multicenter trial involving over 7,700 women that assessed the impact of a yearly infusion of intravenous zoledronic acid (Reclast, Novartis) in postmenopausal women with osteoporosis. The study, which was recently published in the New England Journal of Medicine, found that the yearly infusion reduced the risk of morphometric vertebral fracture by 70 percent and reduced the risk of hip fracture by 41 percent.

“Based on the results of the study, (zoledronic acid) seems to be a viable option for the treatment of osteoporosis,” notes Gail C. Davis, RN, EdD, a Professor in the College of Nursing at Texas Woman’s University at Denton, Tx. “Based on the limited information available to date, the fracture reduction is at least as good as or better than that associated with oral bisphosphonates.”

Dr. Davis says the intravenous option “seems especially attractive” for those who have gastrointestinal issues or compliance issues with traditional oral bisphosphonates.

In regard to postmenopausal women with osteoporosis, a yearly infusion agent reportedly reduces the risk of hip fracture by 41 percent.

“Those experiencing cognitive decline could especially benefit because they are often frail, older women at high risk for falls and related hip fractures,” points out Dr. Davis.

Dr. Davis also notes that the study found significant increases in bone mineral density (BMD) at the hip, lumbar spine and femoral neck over the study period, as well as “significant decreases in all three biochemical markers of bone turnover at 12 months.”

However, there is a need for more research on the modality, according to Dr. Davis. She says “the most troubling finding (of the study) was (the fact) that atrial fibrillation occurred significantly more often in the control group than in the placebo group.”

Dr. Davis also wonders if treatment with zoledronic acid past three years will yield more adverse effects and whether the positive changes in bone mineral density continue after 12 months. Zoledronic acid is currently indicated for the treatment of Paget’s Disease and is marketed with the brand name of Zometa. It would reportedly be marketed as Reclast if it receives an FDA indication for osteoporosis.

FDA Approves Fosamax Plus D For Osteoporosis
By Aaron Becker, Associate Editor

The FDA has recently approved alendronate sodium/cholecalciferol (Fosamax Plus D, Merck), a weekly tablet that combines alendronate sodium 70 mg (Fosamax) with 5600 international units (IU) of vitamin D3 for patients with osteoporosis.

In her clinical experience, Kiplee Bell, MS, PA-C, says Fosamax Plus D has been “well tolerated” in her patients with osteoporosis.

Fosamax Plus D also reportedly falls in line with recently revised recommendations from the National Osteoporosis Foundation (NOF), which suggested an increase in vitamin D intake from 800 to 1,000IU per day.

“In patients with moderate gastrointestinal disturbance or mild to moderate risk for osteoporosis, I had been using Vitamin D 800 IU daily as a supplement,” explains Bell, who has a master’s degree in gerontology and enjoys serving the gero-rheumatology patient. “This recent news allows patients to increase the dose.”

In regard to her prior experience with Fosamax, Bell says she had “a small percentage of patients” who could not tolerate the drug as well as other bisphosphonates due to a history of moderate to severe gastronintestinal issues. She says the convenience of combining Fosamax with Vitamin D will be beneficial in facilitating compliance.

“Efficacy, safety and convenience always improves compliance,” notes Bell.

Research Shows Sustained Efficacy Of Rituximab For RA
By Aaron Becker, Associate Editor

When patients with RA have an inadequate response to tumor necrosis factor (TNF) inhibitors, what treatment options can clinicians consider for these patients?

Two studies that were recently presented at the aforementioned EULAR conference found sustained efficacy with repeat courses of rituximab (Rituxan, Genentech) in patients with RA who had previously failed to respond to two or more TNF inhibitors.

For example, in one of the studies, 63 percent of patients who received one course of rituximab (after failing two or more prior TNF therapies) had an ACR 20 response. After the second course of rituximab therapy, 70 percent of the patients had an ACR 20 response. After the third course of rituximab, 78 percent of the patients had an ACR 20 response.

Joel M. Kremer, MD, the lead author of the study discussed above, says these findings may give clinicians more confidence in prescribing rituximab for RA patients with multiple TNF-inhibitor failures.

Dr. Kremer, the head of the Division of Rheumatology at Albany Medical College in Albany, N.Y., says he observes an inadequate response to TNF inhibitors among RA patients approximately one-third of the time in his practice. In monitoring patient response to TNF inhibitors, Dr. Kremer says clinicians should measure standard outcomes and assess for tender and swollen joints, and the patient’s overall sense of well-being.

Dr. Kremer says he would like to see more studies examining the treatment of rituximab in RA patients who have an inadequate response to other biologics as well.

Can Adalimumab Help Patients With PsA Who Fail DMARD Therapy?
By Aaron Becker, Associate Editor

Researchers of a new study have found favorable efficacy and safety with adalimumab (Humira, Abbott) in patients with active psoriatic arthritis (PsA) who have failed previous DMARD therapy.

The 100-patient study, which was recently published in the Journal of Rheumatology, found that 39 percent of patients studied achieved an ACR 20 response at 12 weeks after having subcutaneous injections of adalimumab 40 mg every other week. In comparison, only 16 percent of patients with placebo achieved an ACR 20 response.

(Photo courtesy of the American College of Rheumatology) In regard to treating psoriatic arthritis (as shown above), Alan Kivitz, MD, and Eileen Rogers, PA-C, have both had “excellent success” with adalimumab in clinical practice.

After week 12, researchers also gave adalimumab to patients in the initial placebo group. Out of this group, 57 percent of patients had an ACR 20 response at 24 weeks. Those from the initial adalimumab treatment group continued with the therapy and 65 percent of these patients achieved an ACR 20 response at 24 weeks. Alan Kivitz, MD, a co-author of the study, says the findings “reinforce the clinical evidence that patients who are only partial responders to DMARDs will respond to adalimumab.”

Dr. Kivitz, the Director of the Altoona Arthritis Center in Altoona, Pa., and Eileen Rogers, PA-C, have had “excellent success” using adalimumab for PsA in clinical practice.

Rogers and Dr. Kivitz agree that DMARD therapy is standard treatment for PsA. In most cases, Dr. Kivitz uses DMARDs, predominantly methotrexate, due to requirements of third-party payers, cost and individual patient preference. However, in the event of DMARD failure, Dr. Kivitz will consider TNF inhibitors.

Rogers notes that she has a lower threshold for starting a TNF inhibitor in patients with PsA. Rogers, who practices in South Carolina, says a patient does not have to maximize his or her methotrexate dose before starting a TNF-inhibitor. Dr. Kivitz adds there are certainly many PsA patients who may be considered as candidates for first-line therapy with adalimumab.

Revealing RA’s Impact On Sleep: What One Study Shows
By Aaron Becker, Associate Editor

A recent study published in Musculoskeletal Care determined that 35 percent of the rheumatoid arthritis (RA) patients enrolled experienced sleep disruption that occurred frequently or all the time, according to the study authors.

“This suggests that at least one in four people with RA will have a problem with sleep disruption,” notes Gareth Treharne, MSc, PhD, the lead author of the study and a Research Fellow at the School of Psychology at the University of Birmingham in the United Kingdom.

Approximately 35 percent of patients with RA experienced frequent sleep disruption, according to a recent study.

Antonio Giannelli, MsA, PA-C, a physician assistant of 30 years and a Clinical Instructor within the Department of Internal Medicine at Michigan State University, says sleep disruption is “fairly common among patients with RA,” especially during the early stage of the disease and if the disease is very active. The study authors note that sleep disruption was directly related to a patient’s level of perceived stress, which leads to questions related to psychological treatment alongside typical RA therapies. The study also notes that those with RA experiencing sleep disruption were “more likely to be taking antidepressants.”

Both Dr. Treharne and George D. Kitas, MD, PhD, FRCP, a co-author of the study, note it is important for clinicians to regularly reevaluate a patient’s need for antidepressants to improve sleep and address any potential drug-to-drug interactions with existing medications. Accordingly, they say clinicians should avoid co-prescription within or across classes of antidepressants; monitor the synergistic hypotensive effect of antidepressants in patients on beta-blockers; and be wary of using antidepressants in people with unresolved DMARD-related liver abnormalities.

Giannelli says comorbid diseases, such as diabetes, can complicate the variables with treatment of sleep-related issues.

While the study authors suggest that cognitive behavior therapy may be helpful in patients with sleep disruption and RA, Giannelli rarely refers patients for this therapy.

“Patients appear to be less receptive to cognitive behavioral therapy and worry as to whether their insurance will cover it,” adds Giannelli. He encourages RA patients with sleep disruption to learn relaxation techniques to help them with falling asleep.

Study Reveals Mixed Results On Paroxetine For Fibromyalgia
By Aaron Becker, Associate Editor

A recently released study has provided new information concerning the potential benefits of paroxetine (Paxil CR, GlaxoSmithKline) in patients with fibromyalgia.

The study, which was published in the American Journal of Medicine, determined that paroxetine controlled release was well tolerated and improved the overall symptomatology of patients with fibromyalgia without mood or anxiety disorders. However, study authors conceded that the effect of the drug on pain was “less robust.”

“I am not surprised to read that paroxetine failed to demonstrate efficacy in the treatment of fibromyalgia’s defining characteristic — chronic widespread pain,” admits Patrick Wood, MD, an Assistant Professor at Louisiana State University Health Sciences Center in Shreveport, La.

Dr. Wood says paroxetine’s limited results in reducing chronic fibromyalgia pain are similar to the results of other selective serotonin reuptake inhibitors (SSRIs) and confirms his belief that serotonin does not play a central role in the fundamental pathophysiology of the disorder. However, he says paroxetine’s improvement in overall symptomatology “speaks to the multidimensional aspect of this disorder and the probable existence of biological subtypes within the greater patient population.”

The 116-patient study also found that side effects such as drowsiness, dry mouth, blurred vision, genital disorders and anxiety were more common within the paroxetine-controlled release group. Dr. Wood adds that paroxetine’s association with weight gain “is a significant liability” in regard to the treatment of a disorder that is already associated with progressive weight gain in a majority of patients.

Dr. Wood says he doubts paroxetine will receive FDA approval for the treatment of FM due to its inability to significantly alleviate pain. He adds that the growing awareness that mixed serotonin-norepinephrine reuptake inhibitors (SNRIs) appear to be superior to SSRIs for the treatment of this disorder “works against paroxetine as a first- or even a second-line treatment.”

Study Hints At Potential Of Single Injection For OA Knee Pain
By Aaron Becker, Associate Editor

A new study shows that Synvisc-One, a single six ml injection of hylan G-F 20, provides significant relief of OA knee pain for six months.

For practitioners who regularly consider viscosupplementation in treating osteoarthritis (OA) of the knee, findings from a recent study suggest that a single injection of a viscosupplementation agent may be a viable option in the near future.

The 253-patient study, which was presented at the aforementioned EULAR conference, found that a single 6 ml injection of hylan G-F 20 (Synvisc-One, Genzyme) provided a 36 percent reduction in OA knee pain over a 26-week period. Based upon these study results, Genzyme, the manufacturer of Synvisc, has filed for FDA approval of Synvisc-One for OA knee pain.

Currently, the viscosupplementation agent Synvisc, which is FDA-approved for the treatment of OA knee pain, requires three 2 ml intraarticular injections that practitioners provide at one-week intervals. Synvisc-One would reportedly combine those three injections into one 6 ml injection.

If the one injection dosing receives FDA approval, Mike Rudzinski, PA-C, RPh, says the convenience of Synvisc-One would be welcomed.

“This convenience, if not outweighed by adverse events, will make it more attractive as a treatment option for myself and patients as well,” notes Rudzinski, a physician assistant at Buffalo Veterans Affairs Medical Center in Buffalo, N.Y.

The study authors noted that the Synvisc-One treatment group had a comparable safety profile to the placebo group.

Diacerein: Is It A Viable Option For Knee OA?
By Aaron Becker, Associate Editor

A recent study found that diacerein was just as effective as the non-steroidal antiinflammatory drug (NSAID) piroxicam in reducing pain and improving function. Researchers also found that diacerein had a better safety profile as well.

The study, which was published recently in Osteoarthritis and Cartilage, looked at the efficacy of diacerein in treating osteoarthritis (OA) of the knee. Researchers evaluated 484 patients during a 16-week, randomized, double-blind, placebo-controlled trial.

While Linda Davis, MHS, PA-C notes she has no direct experience with diacerein, she says other researchers have suggested that diacerein may have a place for people with OA who have concomitant disorders such as hypertension, diabetes or coronary artery disease. For these patients, NSAIDs may not be the optimal choice or may be contraindicated, notes Davis, an Assistant Professor at the University of North Texas Health Science Center.

However, Davis says other studies are needed to gauge the short- and long-term effectiveness and toxicity of diacerein before she considers adding it to her armamentarium for knee OA.

When it comes to treating knee OA, Davis says she uses hyaluronic acid and NSAIDs such as Etodolac and other agents.

She also adds that side effects of diacerein include gastrointestinal issues, diarrhea, heartburn and stomach pain. The study authors note that mild to moderate bowel habits were the most common adverse effect within the study population.

In Brief
• Abbott recently announced that it has filed with the FDA and the European Medicines Agency (EMEA) for marketing approval of adalimumab (Humira) for the treatment of juvenile rheumatoid arthritis (JRA) in the U.S. and juvenile idiopathic arthritis (JIA) in the European Union. The filings were reportedly based upon results from a phase III clinical study of patients with JRA.

• In related news, Abbott also announced that it received approval from the European Commission to market adalimumab as a treatment for severe Crohn’s disease.

• Recently, Genzyme Biosurgery conducted a survey of 204 patients with osteoarthritis (OA) of the knee. According to the survey, approximately one-third of patients with knee OA missed work or stopped working because of the disease. The survey also revealed that most patients with OA were diagnosed before the age of 50.

• The Food and Drug Administration (FDA) has issued a conditional approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis. Bazedoxifene is a selective estrogen receptor modulator manufactured by Wyeth Pharmecuticals.

• Genentech has submitted a supplemental biologics license application (sBLA) for rituximab (Rituxan) in combination with methotrexate for inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor medications. The company says the filing was based upon X-ray data from the phase III REFLEX study, which was presented at the EULAR conference.