Rheum Round-up: FDA Approves Lyrica Generics, J&J Under Investigation, and More

Here are the top stories covered by DocWire News this week in the Rheumatology section. In this edition, read about the generic versions of Lyrica, Johnson & Johnson’s Remicade repercussions, filgotinib outcomes for rheumatoid arthritis, and short-stem hip arthroplasty efficacy.

The Food and Drug Administration (FDA) announced the approval of several generic versions of Lyrica (pregabalin). Lyrica is approved for the treatment of several conditions, including, according to a press release, “neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.” Lyrica is manufactured and sold by Pfizer. Two studies were conducted to evaluate the use of pregabalin in fibromyalgia patients. The first was a 14-week, double-blind, placebo-controlled, multicenter study. Pain reduction was observed as early as the first week. Any improvement in pain was reported in 47.6% of placebo patients (95% confidence interval [CI] 40.0–55.2%), 68.1% of 300 mg patients (95% CI 60.9–75.3%), 77.8% of 450 mg patients (95% CI 71.5–84%), and 66.1% of 600 mg patients (95% CI 59.1–73.1%).

Johnson & Johnson disclosed in a regulatory filing that it is being investigated by the U.S. Federal Trade Commission (FTC) for potentially violating antitrust laws in connection with its drug Remicade (infliximab). Remicade received FDA approval in 1998 for the treatment of a variety of diseases, including rheumatoid arthritis (RA) (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. According to J&J, the FTC issued a “civil investigative demand”—similar to a subpoena—in June to examine the company’s contracting practices. The announcement from J&J comes amid a two-year legal battle with competitor Pfizer, which sued J&J in 2017. According to Pfizer, J&J signed anti-competitive contracts with insurers that prevented Pfizer’s drug Inflectra, a Remicade biosimilar that hit the market in 2016, from competing on the market. Remicade revenue did not fall as much as expected, with reports estimating that it has managed to maintain more than 90% of the market.

Patients with active RA who are nonresponsive or intolerant to biologic disease-modifying antirheumatic drug (bDMARD) therapy may benefit from filgotinib. The 24-week study spanned 114 sites internationally and took place between July 2016 and June 2018. A total of 449 adult RA patients were randomized to either filgotinib 200 mg, filgotinib 100 mg, or placebo. Patients had moderately to severely active RA and had a history of inadequate response or intolerance to at least one prior bDMARD. After 12 weeks, ACR20 response was achieved in 66% of filgotinib 200 mg patients and 57.5% of filgotinib 100 mg patients, compared to 31.1% of placebo patients. Both doses of filgotinib were associated with a better response than placebo even in patients who had a history of three or more bDMARDs: filgotinib 200 mg, 70.3%; filgotinib 100 mg, 58.8%; and placebo, 17.6%.

Short-stem total hip arthroplasty may help improve sleep quality. This prospective study included 25 patients (mean age, 68 years; 76% were female) who underwent primary unilateral hip arthroplasty for primary osteoarthritis on the affected hip between January 2016 and August 2016. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to evaluate sleep quality and daytime sleepiness. Prior to surgery, the average PSQI score was 9.1. During the first postoperative week, the score increased slightly, then decreased—for the most part—over the next several months. By month six, the mean score was 4.3—representing normal sleep, the authors said. The mean preoperative ESS was 7.4 and dropped down to 4.2. The researchers called for a randomized controlled trial to compare sleep outcomes between standard- and short-stem hip arthroplasty patients.