Lupus Nephritis Guidelines in Progress

A team of rheumatologists, nephrologists, and pathologists is currently at work on the first-ever ACR guidelines for the screening, diagnosis, and treatment of lupus nephritis. The new guidelines are scheduled for publication this fall and will review modern studies that meet standards of high levels of evidence as well as expert opinion to make recommendations for use by rheumatologists in clinical practice.

Bevra Hahn, MD, chief of rheumatology at the University of California, Los Angeles School of Medicine and former President of ACR, is leading the guideline development committee. She says that the driving force behind the creation of these guidelines now is the recent publication of several high-quality clinical trials on the treatment of the disease, an indicator that it is time to make recommendations on treatment.

“These new guidelines are designed for the practicing physician so they will be concise and they will, as modern guidelines all do, make recommendations and indicate what the level of evidence is. The clinician reading it will be able to see which recommendations are backed by strong evidence, and which are backed by [expert] opinion,” says Dr. Hahn.

The guideline development committee is currently in the process of editing the first draft of the paper. After it moves through these revisions, it will be submitted to the ACR for edits and approvals. “There are a lot of people that need to agree on the guidelines,” Dr. Hahn stresses.

Gathering Data

Initial processes began with a review of the last 20 years of literature in lupus nephritis by an expert panel of the guideline development committee. This process included a review of all prospective clinical trials and cohort studies with large numbers of patients that examined only studies of products currently available for treatment of the disease. These results were passed to the expert panel, which met after the 2010 ACR/ARHP Annual Scientific Meeting in Atlanta to vote on scenarios “as a clinician would see them in the office,” Dr. Hahn said. These scenarios included real-world circumstances such as who should have a biopsy, what the criteria for diagnosis should be, what the treatments are, and what the recommendations for monitoring how patients are responding to these treatments would be.

According to Dr. Hahn, when the voting was tallied, some areas of the expert opinions did not coincide with current textbook information in how to treat lupus nephritis. New scenarios were therefore constructed to clarify the clinical situation. “You find that, with this method, there are some answers that don’t seem to be in line with current practice, and therefore it is likely that people voting did not interpret the scenario in the same way,” Dr. Hahn notes. “Part of the process is to look where there is a lot of discrepancy in people’s opinions. There were different interpretations of scenarios between experts, so we reconstructed [these hypothetical situations].”

Participating doctors were chosen based on their expertise with writing guidelines, their experience with leading large major clinical trials, or a combination of both. Most of the nephrologists chosen to work alongside their ACR counterparts “have worked on U.S. guidelines of nephrology before,” according to Dr. Hahn.

Dr. Hahn also says that one limitation to the guidelines will be the range of products reviewed, because only those products that have gone through high-quality clinical trials in the United States will be seriously considered: “Likely there will be more products released over the next two to three years for management of lupus nephritis … they will be addressed, but we don’t know what will be successful and what won’t be … all we can do is spend a brief time discussing these interesting products.” Dr. Hahn cites belimumab (Benlysta) as an example. Benlysta was recently approved for the treatment of lupus, but its utility in the treatment of lupus nephritis has yet to be studied.

The expected impact of these guidelines is substantial for the rheumatologist in clinical practice. “I think that for clinicians who don’t see many patients with lupus nephritis, it will be helpful because it will be an update on the state of the art,” Dr. Hahn says. “For clinicians quite experienced with lupus nephritis, they will most likely be doing things the way they are recommended anyway … hopefully it will confirm what [they] are already doing.”

Alexandra Schultz is a writer based in New Jersey.