Treat-to-Target Strategy Evaluated for Fibromyalgia Care

Treat-to-target is a widely used approach for rheumatoid arthritis, in which rheumatologists prescribe treatments to reach established benchmarks of disease activity.¹ Is it time for a similar approach for fibro­myalgia treatment, even though its pathogenesis, disease-activity measures and treatment algorithms are less well understood?

Three fibromyalgia researchers present their case in a new paper, “Treat-to-Target Strategy for Fibromyalgia: Opening the Dialogue.”² Challenges include validation of existing diagnostic and treatment algorithms, validation of individualized vs. universal treatment strategies and consensus on criteria to assess the effects of treatment.

“A treat-to-target strategy requires very well-defined criteria, but in fibromyalgia, these are not definite,” says Mary-Ann Fitzcharles, MB, ChB, professor of medicine at McGill University Health Centre in Montreal, Quebec, Canada. Her co-authors are Winfried Hauser, MD, medical director, Psychosomatic Clinic of Internal Medicine at Klinikum Saarbrücken in Saarbrücken, Germany, and Daniel J. Clauw, MD, director of the Chronic Pain and Fatigue Research Center at the University of Michigan Medical School in Ann Arbor, Mich.

The ACR endorsed preliminary diagnostic criteria for fibromyalgia, which were first published in 2010 and modified in 2011, but there are no established benchmarks for disease activity.^3,4

Why We Need Treat to Target

Fibromyalgia is a prevalent disease affecting about 2% of the global population. Its often long-lasting symptoms affect quality of life and function, and it may impact both direct and indirect health costs.^5-7 “About 20–30% of patients with defined inflam­matory joint disease also have underlying fibromyalgia as an important component,” says Dr. Fitzcharles.

Development of a treat-to-target strategy should include clear disease definition, knowledge of long-term consequences of inadequate treatment, effects of and duration of treatment, defined meaningful outcome measures and accepted response criteria, say the authors. Fibromyalgia’s pathogenesis and disease mechanisms are still not well understood, and precise diagnosis may be elusive and delay treatment, says Dr. Fitzcharles. “You have to be sure you have a well-defined condition and must have universally accepted diagnostic criteria,” says Dr. Fitzcharles. Some fibromyalgia experts debate the ACR-endorsed criteria, possibly because widespread pain, the hallmark symptom, may vary greatly in intensity over time and be highly variable between patients.⁸ Patients may express somatic symptoms and mood issues very differently, making them hard to measure among a larger population.⁹

In fibromyalgia, weighting each patient’s symptoms may reflect global health status more effectively than using generic measurements, the authors say.¹⁰

“We need international acceptance of the diagnostic criteria for this condition. We need to know who we are treating,” says Dr. Fitzcharles. “We need long-term epidemiological studies to give us a good idea of what happens to these patients and a clearer understanding of patient outcomes.”

Research shows that adolescents with early-onset fibromyalgia are likely to have symptoms that persist into adulthood, but more data would help clarify long-term outcomes and potential treatment targets, says Dr. Fitzcharles.¹¹

Weighing Treatment Strategies

Standard, effective management strategies for fibromyalgia remain elusive. “Evidence indicates the best treatment intervention is the maintenance of physical activity,” says Dr. Fitzcharles. Nonpharmacologic strategies, along with selective drug treatment, have varying success.¹² “The best we can do is to keep our patients active and well conditioned. We can use medications diligently, but be cautious about side effects. Drugs for the management of fibro­myalgia symptoms have a modest effect at best, and adverse effects may outweigh the positive effects.”

In a study published in Pain in 2014, group acceptance and commitment therapy (GACT) was more effective at improving health-related quality of life than the combination drug treatment of duloxetine and pregabalin.¹³ No evidence has shown that pharmacologic interventions are effective for fatigue, a common fibromyalgia symptom, but some evidence supports the use of physical activity and cognitive-behavioral therapies.^14,15 “Ideally, if we are going to treat to target in fibromyalgia, we need treatments that work,” says Dr. Fitzcharles. A treatment algorithm with a sound evidence base and universal acceptance is necessary, along with more accurate identification of targets for treatment, she says.

An ideal treatment target should be a clinically meaningful, standard outcome measurement that is easy to perform and does not focus on only one symptom, she says. Potential targets include disease activity defined by the patient’s own narrative, or a threshold value on a composite measure such as the Fibromyalgia Impact Questionnaire or the Patient Health Questionnaire 15, according to the paper.^16,17

“I don’t think we will have a universal target in fibromyalgia. We will have to mold targets to individual patients. This is different from counting joints. It will require a different mindset for rheumatologists,” says Dr. Fitzcharles.

Well-defined patient subgroups also are needed to assess treatment effectiveness and identify who is most at risk to examine prevention strategies.

“Fibromyalgia researchers have tried to divide patients into those with primarily physical and somatic symptoms and those with primarily psychosocial symptoms. That might be a simple starting point,” says Dr. Fitzcharles. “We can look at this in two ways: the ideal world and the real world.

“In an ideal world, evidence tells us patients with fibromyalgia treated in a multidisciplinary setting do very well, but it’s expensive and not available in many places. We have to tailor our approach to the real world. We must take care not to ‘over-medicalize’ people, especially those who have an illness that’s been overlooked.”

Susan Bernstein is a freelance medical journalist based in Atlanta.

References

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