2015 American College of Rheumatology Guideline for the treatment of rheumatoid arthritis

OBJECTIVE: To develop a new evidence-based, pharmacologic treatment guideline for rheumatoid arthritis (RA). METHODS: We conducted systematic reviews to synthesize the evidence for the benefits and harms of various treatment options. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to rate the quality of evidence. We employed a group consensus process to grade the strength of recommendations (either strong or conditional). A strong recommendation indicates that clinicians are certain that the benefits of an intervention far outweigh the harms (or vice versa). A conditional recommendation denotes uncertainty over the balance of benefits and harms and/or more significant variability in patient values and preferences. RESULTS: The guideline covers the use of traditional disease-modifying antirheumatic drugs (DMARDs), biologic agents, tofacitinib, and glucocorticoids in early (<6 months) and established (≥6 months) RA. In addition, it provides recommendations on using a treat-to-target approach, tapering and discontinuing medications, and the use of biologic agents and DMARDs in patients with hepatitis, congestive heart failure, malignancy, and serious infections. The guideline addresses the use of vaccines in patients starting/receiving DMARDs or biologic agents, screening for tuberculosis in patients starting/receiving biologic agents or tofacitinib, and laboratory monitoring for traditional DMARDs. The guideline includes 74 recommendations: 23% are strong and 77% are conditional. CONCLUSION: This RA guideline should serve as a tool for clinicians and patients (our two target audiences) for pharmacologic treatment decisions in commonly encountered clinical situations. These recommendations are not prescriptive, and the treatment decisions should be made by physicians and patients through a shared decision-making process taking into account patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

"OBJECTIVE: To develop a new evidence-based, pharmacologic treatment guideline for rheumatoid arthritis (RA). METHODS: We conducted systematic reviews to synthesize the evidence for the benefits and harms of various treatment options. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to rate the quality of evidence. We employed a group consensus process to grade the strength of recommendations (either strong or conditional). A strong recommendation indicates that clinicians are certain that the benefits of an intervention far outweigh the harms (or vice versa). A conditional recommendation denotes uncertainty over the balance of benefits and harms and/or more significant variability in patient values and preferences. RESULTS: The guideline covers the use of traditional disease-modifying antirheumatic drugs (DMARDs), biologic agents, tofacitinib, and glucocorticoids in early (<6 months) and established (≥6 months) RA. In addition, it provides recommendations on using a treat-to-target approach, tapering and discontinuing medications, and the use of biologic agents and DMARDs in patients with hepatitis, congestive heart failure, malignancy, and serious infections. The guideline addresses the use of vaccines in patients starting/receiving DMARDs or biologic agents, screening for tuberculosis in patients starting/receiving biologic agents or tofacitinib, and laboratory monitoring for traditional DMARDs. The guideline includes 74 recommendations: 23% are strong and 77% are conditional. CONCLUSION: This RA guideline should serve as a tool for clinicians and patients (our two target audiences) for pharmacologic treatment decisions in commonly encountered clinical situations. These recommendations are not prescriptive, and the treatment decisions should be made by physicians and patients through a shared decision-making process taking into account patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies."

2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis

OBJECTIVE: To develop a new evidence-based, pharmacologic treatment guideline for rheumatoid arthritis (RA). METHODS: We conducted systematic reviews to synthesize the evidence for the benefits and harms of various treatment options. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to rate the quality of evidence. We employed a group consensus process to grade the strength of recommendations (either strong or conditional). A strong recommendation indicates that clinicians are certain that the benefits of an intervention far outweigh the harms (or vice versa). A conditional recommendation denotes uncertainty over the balance of benefits and harms and/or more significant variability in patient values and preferences. RESULTS: The guideline covers the use of traditional disease-modifying antirheumatic drugs (DMARDs), biologic agents, tofacitinib, and glucocorticoids in early (<6 months) and established (≥6 months) RA. In addition, it provides recommendations on using a treat-to-target approach, tapering and discontinuing medications, and the use of biologic agents and DMARDs in patients with hepatitis, congestive heart failure, malignancy, and serious infections. The guideline addresses the use of vaccines in patients starting/receiving DMARDs or biologic agents, screening for tuberculosis in patients starting/receiving biologic agents or tofacitinib, and laboratory monitoring for traditional DMARDs. The guideline includes 74 recommendations: 23% are strong and 77% are conditional. CONCLUSION: This RA guideline should serve as a tool for clinicians and patients (our two target audiences) for pharmacologic treatment decisions in commonly encountered clinical situations. These recommendations are not prescriptive, and the treatment decisions should be made by physicians and patients through a shared decision-making process taking into account patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

Retroviral risk factors in patients with autoimmune disease.

OBJECTIVE: Retroviruses can cause immunoregulatory disturbances and may play a role in the pathogenesis of autoimmune disorders. Little is known about the frequency of behavioral risk factors for exogenous retroviral infections in patients with autoimmune diseases. We compare the frequency of recognized risk factors for retroviral infections among patients with systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and controls. METHODS: Patients with SLE and RA from a university rheumatology clinic and control patients were enrolled in this study. The presence of retroviral risk factors (intravenous drug use, prostitution, increased number of sex partners, sexually transmitted diseases, high risk sex partners, blood transfusion) was determined by a self-administered questionnaire. RESULTS: We surveyed 81 patients with SLE and 117 with RA and 100 healthy controls. Patients in all groups reported similar exposure to all risk factors surveyed for retroviral infection except sexually transmitted disease, which was reported more often in patients with SLE (25% of SLE versus 11% of RA and 11% of controls, p = 0.013). CONCLUSION: Self-reported retroviral risk factors were generally not increased in patients with autoimmune disease compared to healthy controls; the role of exogenous retroviruses in the pathogenesis of SLE and RA remains unclear.

Recombinant human interleukin-1 receptor type I in the treatment of patients with active rheumatoid arthritis.

OBJECTIVE: To determine the safety and efficacy of recombinant soluble human interleukin-1 receptor type I (rHuIL-1RI) administered subcutaneously in patients with active rheumatoid arthritis (RA). METHODS: Twenty-three patients with active RA (>5 swollen joints) were enrolled into a randomized, double-blind, 2-center study. Patients received subcutaneous doses of rHuIL-1RI or placebo for 28 consecutive days. Patients were treated with 125, 250, 500, or 1,000 micrograms/m2/day of rHuIL-1RI. Physical examinations and laboratory assessments were performed at baseline (day 1), and 8, 15, 22, 29, 43, and 57 days after the start of the study. Analysis of peripheral blood by flow cytometry was performed on days 1 and 29 to determine the effects of rHuIL-1RI on the distribution and phenotypic characteristics of circulating inflammatory cells. RESULTS: Four of 8 patients who received rHuIL-1RI at 1,000 micrograms/m2/day demonstrated improvement in at least 1 of 8 individual measures of disease activity; however, only 1 of these 4 patients experienced clinically relevant improvement as defined by predetermined criteria. None of the patients treated with smaller doses of rHuIL-1RI, and none of the placebo-treated control patients, experienced any improvement as defined by the predetermined criteria. Monocyte cell surface IL-1alpha was significantly reduced following treatment with rHuIL-1RI at each dosage. Administration of rHuIL-1RI was stopped prematurely because of dose-limiting rashes in 2 patients treated with 1,000 micrograms/m2/day. No other adverse events prevented completion of the study. CONCLUSION: Only 1 patient, who was treated with the highest concentration of rHuIL-1RI employed (1,000 micrograms/m2/day), demonstrated clinically relevant improvement in this phase I study on this small group of patients with active RA. Dose-limiting toxicity was also observed in 2 patients treated with this highest concentration of rHuIL-1RI. Treatment with rHuIL-1RI did result in a reduction of monocyte cell surface IL-1alpha, which indicates that the dosages of rHuIL-1RI employed were functional.