Jeff Craven

 

Three different regimens of antiretroviral therapy did not produce significantly different adverse birth outcomes in women with HIV despite previous research showing an increased risk in premature birth or death in infants after a regimen of tenofovir, emtricitabine, and ritonavir-boosted lopinavir therapy, according to a recent analysis of two multicenter cohort studies published in the New England Journal of Medicine.

Kathryn Rough, ScD, of the Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues analyzed 4,646 birth outcomes in the SMARTT (NCT01310023) and P1025 (NCT00028145) trials from 3,847 unique women who received tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r), zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r), or TDF–FTC with ritonavir-boosted atazanavir (ATV/r) during gestation. There were 954 infants or fetuses exposed to ZDV–3TC–LPV/r (20.5%), 539 infants or fetuses exposed to TDF–FTC–ATV/r (11.6%), and 128 infants or fetuses exposed to TDF–FTC–LPV/r (2.8%), with 4,480 singleton, 80 twin, and 2 triplet pregnancies.

©PhotoDisk

“TDF–FTC–LPV/r was rarely used by pregnant women with HIV infection in either U.S.-based cohort, and its use in other settings is also limited, because it is not among the first-line regimens recommended by the WHO,” Dr. Rough and her colleagues wrote in their study (N Engl J Med 2018;378:1593-603).

“Concerns regarding the use of TDF–FTC–LPV/r during pregnancy remain; further investigation is warranted to understand why women who initiated TDF–FTC– LPV/r before conception had higher risks of preterm birth, low birth weight, and any adverse outcome than women who initiated ZDV–3TC– LPV/r or TDF–FTC–ATV/r before conception in subgroup analyses.”

Overall, there was a premature birth risk between 16.1% and 21.4% and a low birth weight risk between 16.2% and 23.8% across all antiretroviral therapy regimens, with an overall adverse outcome rate between 23.7% and 28.1%. For women who received TDF–FTC–LPV/r, there was a risk ratio of 0.90 (95% confidence interval, 0.60-1.33) for preterm births, 1.13 for low birth weight (95% CI, 0.78-1.64) and 0.92 for any adverse outcome (95% CI, 0.67-1.28) compared with women who received ZDV–3TC–LPV/r.

“For the outcomes of preterm birth, low birth weight, and any adverse outcome, TDF–FTC–ATV/r appeared to have lower risks than the LPV/r-based regimens; however, many of these associations were not significant,” the authors wrote.

Women who received TDF–FTC–LPV/r had a risk ratio of 1.14 (95% CI, 0.75-1.72) and a low-birth-weight risk ratio of 1.45 (95% CI, 0.96-2.17), compared with women who received TDF-FTC-ATV/r. Regarding very-low-birth-weight and very-preterm birth, the researchers noted no significant differences among regimen groups.

 

One author reported stock from Abbott, AbbVie, Novartis, and Roche outside the submitted work; one author reported personal fees from Boehringer-Ingelheim; and five authors reported grants from pharmaceutical companies and Google outside the submitted work.

SOURCE: Rough K et al. N Engl J Med 2018;378:1593-603.

 

Three different regimens of antiretroviral therapy did not produce significantly different adverse birth outcomes in women with HIV despite previous research showing an increased risk in premature birth or death in infants after a regimen of tenofovir, emtricitabine, and ritonavir-boosted lopinavir therapy, according to a recent analysis of two multicenter cohort studies published in the New England Journal of Medicine.

Kathryn Rough, ScD, of the Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues analyzed 4,646 birth outcomes in the SMARTT (NCT01310023) and P1025 (NCT00028145) trials from 3,847 unique women who received tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r), zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r), or TDF–FTC with ritonavir-boosted atazanavir (ATV/r) during gestation. There were 954 infants or fetuses exposed to ZDV–3TC–LPV/r (20.5%), 539 infants or fetuses exposed to TDF–FTC–ATV/r (11.6%), and 128 infants or fetuses exposed to TDF–FTC–LPV/r (2.8%), with 4,480 singleton, 80 twin, and 2 triplet pregnancies.

©PhotoDisk

“TDF–FTC–LPV/r was rarely used by pregnant women with HIV infection in either U.S.-based cohort, and its use in other settings is also limited, because it is not among the first-line regimens recommended by the WHO,” Dr. Rough and her colleagues wrote in their study (N Engl J Med 2018;378:1593-603).

“Concerns regarding the use of TDF–FTC–LPV/r during pregnancy remain; further investigation is warranted to understand why women who initiated TDF–FTC– LPV/r before conception had higher risks of preterm birth, low birth weight, and any adverse outcome than women who initiated ZDV–3TC– LPV/r or TDF–FTC–ATV/r before conception in subgroup analyses.”

Overall, there was a premature birth risk between 16.1% and 21.4% and a low birth weight risk between 16.2% and 23.8% across all antiretroviral therapy regimens, with an overall adverse outcome rate between 23.7% and 28.1%. For women who received TDF–FTC–LPV/r, there was a risk ratio of 0.90 (95% confidence interval, 0.60-1.33) for preterm births, 1.13 for low birth weight (95% CI, 0.78-1.64) and 0.92 for any adverse outcome (95% CI, 0.67-1.28) compared with women who received ZDV–3TC–LPV/r.

“For the outcomes of preterm birth, low birth weight, and any adverse outcome, TDF–FTC–ATV/r appeared to have lower risks than the LPV/r-based regimens; however, many of these associations were not significant,” the authors wrote.

Women who received TDF–FTC–LPV/r had a risk ratio of 1.14 (95% CI, 0.75-1.72) and a low-birth-weight risk ratio of 1.45 (95% CI, 0.96-2.17), compared with women who received TDF-FTC-ATV/r. Regarding very-low-birth-weight and very-preterm birth, the researchers noted no significant differences among regimen groups.

 

One author reported stock from Abbott, AbbVie, Novartis, and Roche outside the submitted work; one author reported personal fees from Boehringer-Ingelheim; and five authors reported grants from pharmaceutical companies and Google outside the submitted work.

SOURCE: Rough K et al. N Engl J Med 2018;378:1593-603.

 

Three different regimens of antiretroviral therapy did not produce significantly different adverse birth outcomes in women with HIV despite previous research showing an increased risk in premature birth or death in infants after a regimen of tenofovir, emtricitabine, and ritonavir-boosted lopinavir therapy, according to a recent analysis of two multicenter cohort studies published in the New England Journal of Medicine.

Kathryn Rough, ScD, of the Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues analyzed 4,646 birth outcomes in the SMARTT (NCT01310023) and P1025 (NCT00028145) trials from 3,847 unique women who received tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r), zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r), or TDF–FTC with ritonavir-boosted atazanavir (ATV/r) during gestation. There were 954 infants or fetuses exposed to ZDV–3TC–LPV/r (20.5%), 539 infants or fetuses exposed to TDF–FTC–ATV/r (11.6%), and 128 infants or fetuses exposed to TDF–FTC–LPV/r (2.8%), with 4,480 singleton, 80 twin, and 2 triplet pregnancies.

©PhotoDisk

“TDF–FTC–LPV/r was rarely used by pregnant women with HIV infection in either U.S.-based cohort, and its use in other settings is also limited, because it is not among the first-line regimens recommended by the WHO,” Dr. Rough and her colleagues wrote in their study (N Engl J Med 2018;378:1593-603).

“Concerns regarding the use of TDF–FTC–LPV/r during pregnancy remain; further investigation is warranted to understand why women who initiated TDF–FTC– LPV/r before conception had higher risks of preterm birth, low birth weight, and any adverse outcome than women who initiated ZDV–3TC– LPV/r or TDF–FTC–ATV/r before conception in subgroup analyses.”

Overall, there was a premature birth risk between 16.1% and 21.4% and a low birth weight risk between 16.2% and 23.8% across all antiretroviral therapy regimens, with an overall adverse outcome rate between 23.7% and 28.1%. For women who received TDF–FTC–LPV/r, there was a risk ratio of 0.90 (95% confidence interval, 0.60-1.33) for preterm births, 1.13 for low birth weight (95% CI, 0.78-1.64) and 0.92 for any adverse outcome (95% CI, 0.67-1.28) compared with women who received ZDV–3TC–LPV/r.

“For the outcomes of preterm birth, low birth weight, and any adverse outcome, TDF–FTC–ATV/r appeared to have lower risks than the LPV/r-based regimens; however, many of these associations were not significant,” the authors wrote.

Women who received TDF–FTC–LPV/r had a risk ratio of 1.14 (95% CI, 0.75-1.72) and a low-birth-weight risk ratio of 1.45 (95% CI, 0.96-2.17), compared with women who received TDF-FTC-ATV/r. Regarding very-low-birth-weight and very-preterm birth, the researchers noted no significant differences among regimen groups.

 

One author reported stock from Abbott, AbbVie, Novartis, and Roche outside the submitted work; one author reported personal fees from Boehringer-Ingelheim; and five authors reported grants from pharmaceutical companies and Google outside the submitted work.

SOURCE: Rough K et al. N Engl J Med 2018;378:1593-603.

 

Patients with systemic lupus erythematosus (SLE) who were hypocomplementemic and anti–double-stranded DNA (anti-dsDNA) positive took weekly subcutaneous belimumab in addition to their standard therapy and saw reduced disease activity and fatigue at 1 year, compared with patients taking a placebo, according to results of a phase 3, double-blinded study. These results suggest the subcutaneous version of the monoclonal antibody therapy could be administered at home without patients visiting a hospital, the investigators wrote in Arthritis and Rheumatology.

“Intravenous administration of belimumab is an obstacle to treatment for many patients due to the need to go to the hospital for drug infusions. Thus, a higher number of patients could benefit from this treatment,” Andrea Doria, MD, from the University of Padua (Italy) stated in a press release. “The self-administration of subcutaneous belimumab makes hospital access unnecessary, which leads to economic savings for patients and the community.”

enot-poloskun/iStock/Getty Images Plus

Dr. Doria and his colleagues randomized 356 patients with SLE who were hypocomplementemic (low C3 [less than 90 mg/dL] and/or low C4 [less than 10 mg/dL]) and anti-dsDNA+ (greater than or equal to 30 IU/mL) to receive weekly subcutaneous belimumab (200 mg) or placebo in a 2:1 allocation ratio in addition to standard SLE therapy. Patients had moderate to severe SLE as determined by a Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of 8 or higher.

Researchers set a primary endpoint of response rate according to SLE Responder Index (SRI4), no new British Isles Lupus Assessment Group organ domain A or B scores, and less than a 0.3 increase in Physician’s Global Assessment score at 52 weeks, compared with baseline scores; the secondary endpoints included corticosteroid use reduction between week 40 and week 52 of 25% or more to 7.5 mg/day or less, change in Functional Assessment of Chronic Illness Therapy–Fatigue score, and measurement of time to severe flare as measured by the SLE Flare Index.

At 52 weeks, 64.6% of patients in the belimumab group responded according to SRI4, compared with 47.2% of patients in the placebo group (P = .0014). The researchers attributed the high SRI4 response rate for the placebo group to “administration of SoC [standard SLE therapy]; increased chance of receiving active treatment due to the unbalanced randomization schedule, thereby resulting in a psychological benefit; and the high frequency of visits and patient satisfaction associated with clinical trials.”

Patients had lower flare rates according to the SLE Flare Index in the belimumab group (31.5%), compared with placebo (14.1%), and those in the former group had a 62% reduction in severe flares, compared with the placebo group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.61; P less than .0001). More patients taking belimumab reduced their use of corticosteroids (20.7%) than did those taking the placebo (11.4%) (odds ratio, 2.08; 95% CI, 0.91-4.77; P = .0844). Of patients taking belimumab, 44.8% had a Functional Assessment of Chronic Illness Therapy–Fatigue score of 4 or higher at week 52, compared with 33.3% of patients taking placebo (OR, 1.82; 95% CI, 1.10-3.01; P = .0199).

Regarding adverse events, there were 88 (81.5%) adverse events in the placebo group, with 29 (26.9%) of those events considered to have occurred during treatment, compared with 79 of 194 (31.9%) adverse events attributed to treatment in the belimumab group. The researchers reported 25 patients in the placebo group (23.1%) and 33 patients in the belimumab group (13.3%) had serious adverse events. Postinjection systemic reactions occurred in 21 patients (8.5%) and 13 patients (12.0%) in the belimumab and placebo groups, respectively.

 

“Some aspects of this study were identified as potential limitations,” Dr. Doria and his colleagues wrote. “Within the hypocomplementemic and anti-dsDNA positive subset population, only 65.7% of patients received steroids greater than 7.5 mg/day at baseline; thus (as in the overall population), this endpoint was not powered for statistical significance. In addition, this study excluded patients with SELENA-SLEDAI less than 8, active nephritis, or active CNS disease at screening.”

The study was funded, conducted, and designed by GlaxoSmithKline. Five authors have shares in and are employees of GSK; another was an employee of GSK at the time of the study. Seven authors declared consulting fees, grants and other remuneration from pharmaceutical companies, including GSK.

SOURCE: Doria A et al. Arthritis Rheumatol. 2018 Apr 18. doi: 10.1002/art.40511.

 

Patients with systemic lupus erythematosus (SLE) who were hypocomplementemic and anti–double-stranded DNA (anti-dsDNA) positive took weekly subcutaneous belimumab in addition to their standard therapy and saw reduced disease activity and fatigue at 1 year, compared with patients taking a placebo, according to results of a phase 3, double-blinded study. These results suggest the subcutaneous version of the monoclonal antibody therapy could be administered at home without patients visiting a hospital, the investigators wrote in Arthritis and Rheumatology.

“Intravenous administration of belimumab is an obstacle to treatment for many patients due to the need to go to the hospital for drug infusions. Thus, a higher number of patients could benefit from this treatment,” Andrea Doria, MD, from the University of Padua (Italy) stated in a press release. “The self-administration of subcutaneous belimumab makes hospital access unnecessary, which leads to economic savings for patients and the community.”

enot-poloskun/iStock/Getty Images Plus

Dr. Doria and his colleagues randomized 356 patients with SLE who were hypocomplementemic (low C3 [less than 90 mg/dL] and/or low C4 [less than 10 mg/dL]) and anti-dsDNA+ (greater than or equal to 30 IU/mL) to receive weekly subcutaneous belimumab (200 mg) or placebo in a 2:1 allocation ratio in addition to standard SLE therapy. Patients had moderate to severe SLE as determined by a Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of 8 or higher.

Researchers set a primary endpoint of response rate according to SLE Responder Index (SRI4), no new British Isles Lupus Assessment Group organ domain A or B scores, and less than a 0.3 increase in Physician’s Global Assessment score at 52 weeks, compared with baseline scores; the secondary endpoints included corticosteroid use reduction between week 40 and week 52 of 25% or more to 7.5 mg/day or less, change in Functional Assessment of Chronic Illness Therapy–Fatigue score, and measurement of time to severe flare as measured by the SLE Flare Index.

At 52 weeks, 64.6% of patients in the belimumab group responded according to SRI4, compared with 47.2% of patients in the placebo group (P = .0014). The researchers attributed the high SRI4 response rate for the placebo group to “administration of SoC [standard SLE therapy]; increased chance of receiving active treatment due to the unbalanced randomization schedule, thereby resulting in a psychological benefit; and the high frequency of visits and patient satisfaction associated with clinical trials.”

Patients had lower flare rates according to the SLE Flare Index in the belimumab group (31.5%), compared with placebo (14.1%), and those in the former group had a 62% reduction in severe flares, compared with the placebo group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.61; P less than .0001). More patients taking belimumab reduced their use of corticosteroids (20.7%) than did those taking the placebo (11.4%) (odds ratio, 2.08; 95% CI, 0.91-4.77; P = .0844). Of patients taking belimumab, 44.8% had a Functional Assessment of Chronic Illness Therapy–Fatigue score of 4 or higher at week 52, compared with 33.3% of patients taking placebo (OR, 1.82; 95% CI, 1.10-3.01; P = .0199).

Regarding adverse events, there were 88 (81.5%) adverse events in the placebo group, with 29 (26.9%) of those events considered to have occurred during treatment, compared with 79 of 194 (31.9%) adverse events attributed to treatment in the belimumab group. The researchers reported 25 patients in the placebo group (23.1%) and 33 patients in the belimumab group (13.3%) had serious adverse events. Postinjection systemic reactions occurred in 21 patients (8.5%) and 13 patients (12.0%) in the belimumab and placebo groups, respectively.

 

“Some aspects of this study were identified as potential limitations,” Dr. Doria and his colleagues wrote. “Within the hypocomplementemic and anti-dsDNA positive subset population, only 65.7% of patients received steroids greater than 7.5 mg/day at baseline; thus (as in the overall population), this endpoint was not powered for statistical significance. In addition, this study excluded patients with SELENA-SLEDAI less than 8, active nephritis, or active CNS disease at screening.”

The study was funded, conducted, and designed by GlaxoSmithKline. Five authors have shares in and are employees of GSK; another was an employee of GSK at the time of the study. Seven authors declared consulting fees, grants and other remuneration from pharmaceutical companies, including GSK.

SOURCE: Doria A et al. Arthritis Rheumatol. 2018 Apr 18. doi: 10.1002/art.40511.

 

Patients with systemic lupus erythematosus (SLE) who were hypocomplementemic and anti–double-stranded DNA (anti-dsDNA) positive took weekly subcutaneous belimumab in addition to their standard therapy and saw reduced disease activity and fatigue at 1 year, compared with patients taking a placebo, according to results of a phase 3, double-blinded study. These results suggest the subcutaneous version of the monoclonal antibody therapy could be administered at home without patients visiting a hospital, the investigators wrote in Arthritis and Rheumatology.

“Intravenous administration of belimumab is an obstacle to treatment for many patients due to the need to go to the hospital for drug infusions. Thus, a higher number of patients could benefit from this treatment,” Andrea Doria, MD, from the University of Padua (Italy) stated in a press release. “The self-administration of subcutaneous belimumab makes hospital access unnecessary, which leads to economic savings for patients and the community.”

enot-poloskun/iStock/Getty Images Plus

Dr. Doria and his colleagues randomized 356 patients with SLE who were hypocomplementemic (low C3 [less than 90 mg/dL] and/or low C4 [less than 10 mg/dL]) and anti-dsDNA+ (greater than or equal to 30 IU/mL) to receive weekly subcutaneous belimumab (200 mg) or placebo in a 2:1 allocation ratio in addition to standard SLE therapy. Patients had moderate to severe SLE as determined by a Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of 8 or higher.

Researchers set a primary endpoint of response rate according to SLE Responder Index (SRI4), no new British Isles Lupus Assessment Group organ domain A or B scores, and less than a 0.3 increase in Physician’s Global Assessment score at 52 weeks, compared with baseline scores; the secondary endpoints included corticosteroid use reduction between week 40 and week 52 of 25% or more to 7.5 mg/day or less, change in Functional Assessment of Chronic Illness Therapy–Fatigue score, and measurement of time to severe flare as measured by the SLE Flare Index.

At 52 weeks, 64.6% of patients in the belimumab group responded according to SRI4, compared with 47.2% of patients in the placebo group (P = .0014). The researchers attributed the high SRI4 response rate for the placebo group to “administration of SoC [standard SLE therapy]; increased chance of receiving active treatment due to the unbalanced randomization schedule, thereby resulting in a psychological benefit; and the high frequency of visits and patient satisfaction associated with clinical trials.”

Patients had lower flare rates according to the SLE Flare Index in the belimumab group (31.5%), compared with placebo (14.1%), and those in the former group had a 62% reduction in severe flares, compared with the placebo group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.61; P less than .0001). More patients taking belimumab reduced their use of corticosteroids (20.7%) than did those taking the placebo (11.4%) (odds ratio, 2.08; 95% CI, 0.91-4.77; P = .0844). Of patients taking belimumab, 44.8% had a Functional Assessment of Chronic Illness Therapy–Fatigue score of 4 or higher at week 52, compared with 33.3% of patients taking placebo (OR, 1.82; 95% CI, 1.10-3.01; P = .0199).

Regarding adverse events, there were 88 (81.5%) adverse events in the placebo group, with 29 (26.9%) of those events considered to have occurred during treatment, compared with 79 of 194 (31.9%) adverse events attributed to treatment in the belimumab group. The researchers reported 25 patients in the placebo group (23.1%) and 33 patients in the belimumab group (13.3%) had serious adverse events. Postinjection systemic reactions occurred in 21 patients (8.5%) and 13 patients (12.0%) in the belimumab and placebo groups, respectively.

 

“Some aspects of this study were identified as potential limitations,” Dr. Doria and his colleagues wrote. “Within the hypocomplementemic and anti-dsDNA positive subset population, only 65.7% of patients received steroids greater than 7.5 mg/day at baseline; thus (as in the overall population), this endpoint was not powered for statistical significance. In addition, this study excluded patients with SELENA-SLEDAI less than 8, active nephritis, or active CNS disease at screening.”

The study was funded, conducted, and designed by GlaxoSmithKline. Five authors have shares in and are employees of GSK; another was an employee of GSK at the time of the study. Seven authors declared consulting fees, grants and other remuneration from pharmaceutical companies, including GSK.

SOURCE: Doria A et al. Arthritis Rheumatol. 2018 Apr 18. doi: 10.1002/art.40511.

 

Applying clinical Juvenile Arthritis Disease Activity Score criteria to identify clinically inactive disease in patients with juvenile idiopathic arthritis (JIA) resulted in patients with better long-term functional activity and psychosocial health outcomes, compared with patients whose disease state was assessed using Wallace’s preliminary criteria, according to recent research from the multicenter Childhood Arthritis Prospective Study.

“A challenge is in understanding how best to apply these results in the clinical setting,” wrote Stephanie J.W. Shoop-Worrall of the Arthritis Research UK Centre for Epidemiology at the University of Manchester (England) and her coauthors. “As achievement of CID [clinically inactive disease] according to cJADAS10 [clinical Juvenile Arthritis Disease Activity Score assessed in 10 joints] was associated with equivalent or superior outcomes to Wallace’s preliminary criteria and it is more feasible to complete in clinical practice, due to containing only three routinely collected components, one could argue that this is likely to be a superior treatment target for application in clinical practice.”

szefei/Thinkstock

Ms. Shoop-Worrall and her colleagues identified 832 children (70% female) from eight pediatric and adolescent rheumatology centers in the United Kingdom with rheumatoid factor (RF)–negative or –positive polyarticular JIA or oligoarthritis. The patients were enrolled in the study during 2001-2011 and were assessed for minimal disease activity (MDA) and CID states.

Investigators applied the cJADAS10 to determine MDA, while CID was assessed using both cJADAS10 and Wallace’s preliminary criteria at 1-year follow-up. Children were categorized based on whether they achieved CID according to cJADAS10 only, whether they did so according to Wallace’s preliminary criteria only, whether they did so according to both cJADAS10 and Wallace’s preliminary criteria, or whether they did not achieve CID according to either; they also were categorized based on whether they achieved MDA but not CID according to cJADAS10. Researchers examined patient function, limited joints, and psychosocial health, as well as annual pain between 1-year and 5-year follow-up. The results were recently published in Arthritis & Rheumatology.

“Wallace’s preliminary criteria includes five components, observed or measured by a physician, which must all be absent or in the normal range, but do not include an assessment by the patient or their proxy,” Ms. Shoop-Worrall and her colleagues wrote. “In contrast, the JADAS and cJADAS include fewer overall components, meaning they may be easier to complete in a routine clinical setting, but do include a patient or proxy subjective assessment of patient wellbeing.”

Of the patients analyzed, 68% had oligoarthritis, while 27% had RF-negative and 5% had RF-positive polyarticular JIA. Over half (56%) of patients did not achieve CID, while 21% had achieved CID through both definitions. A further 23% of patients achieved CID in only one definition – 16% of patients according to cJADAS10 and 7% of patients according to Wallace’s preliminary criteria. Patients who achieved CID had significantly increased odds of having no limited joints according to either cJADAS10 (odds ratio, 3.9; 95% confidence interval, 2.5-6.3) or Wallace’s preliminary criteria (OR, 7.5; 95% CI, 2.9-19.2). Patients had better Child Health Questionnaire psychosocial scores when they achieved CID according to either cJADAS10 (coefficient, 5.3; 95% CI, 0.5-10.1) or both cJADAS10 and Wallace’s preliminary criteria (coefficient, 5.5; 95% CI, 2.2-9.5).

When patients’ function was assessed using the Childhood Health Assessment questionnaire, they had significantly increased odds of having no disability recorded when they achieved CID with either cJADAS10 (OR, 4.5; 95% CI, 2.2-9.5) or both criteria (OR 5.2; 95% CI, 2.7-9.9). Patients assessed with Wallace’s preliminary criteria had “no better Child Health Questionnaire psychosocial scores or Childhood Health Assessment questionnaire scores than those with active disease at 1 year.” Most patients who achieved CID also achieved MDA, but 10% of patients reached MDA without achieving CID.

 

The researchers noted that reliance on either cJADAS10 or Wallace’s preliminary criteria alone may miss data needed for clinical treatment. Data obtained from cJADAS10 may lead to additional psychological and physiotherapy treatments not seen in Wallace’s preliminary criteria; however, “relying solely on Wallace’s preliminary criteria may guide immunosuppressive therapy very well, but may ignore other symptoms relevant to the patient.”

“As the two scores differ in their components one could argue that they are not capturing the same construct,” Ms. Shoop-Worrall and her associates wrote. “Wallace’s preliminary criteria capture more objective measures of inflammation, whilst the cJADAS10, through inclusion of a patient well-being measure, may also capture other noninflammatory components of the disease, such as chronic pain and fatigue, not captured by Wallace’s preliminary criteria.”

The authors reported having no relevant financial disclosures for this study.

SOURCE: Shoop‐Worrall SJW et al. Arthritis Rheumatol. 2018 April 12. doi: 10.1002/art.40519.

 

Applying clinical Juvenile Arthritis Disease Activity Score criteria to identify clinically inactive disease in patients with juvenile idiopathic arthritis (JIA) resulted in patients with better long-term functional activity and psychosocial health outcomes, compared with patients whose disease state was assessed using Wallace’s preliminary criteria, according to recent research from the multicenter Childhood Arthritis Prospective Study.

“A challenge is in understanding how best to apply these results in the clinical setting,” wrote Stephanie J.W. Shoop-Worrall of the Arthritis Research UK Centre for Epidemiology at the University of Manchester (England) and her coauthors. “As achievement of CID [clinically inactive disease] according to cJADAS10 [clinical Juvenile Arthritis Disease Activity Score assessed in 10 joints] was associated with equivalent or superior outcomes to Wallace’s preliminary criteria and it is more feasible to complete in clinical practice, due to containing only three routinely collected components, one could argue that this is likely to be a superior treatment target for application in clinical practice.”

szefei/Thinkstock

Ms. Shoop-Worrall and her colleagues identified 832 children (70% female) from eight pediatric and adolescent rheumatology centers in the United Kingdom with rheumatoid factor (RF)–negative or –positive polyarticular JIA or oligoarthritis. The patients were enrolled in the study during 2001-2011 and were assessed for minimal disease activity (MDA) and CID states.

Investigators applied the cJADAS10 to determine MDA, while CID was assessed using both cJADAS10 and Wallace’s preliminary criteria at 1-year follow-up. Children were categorized based on whether they achieved CID according to cJADAS10 only, whether they did so according to Wallace’s preliminary criteria only, whether they did so according to both cJADAS10 and Wallace’s preliminary criteria, or whether they did not achieve CID according to either; they also were categorized based on whether they achieved MDA but not CID according to cJADAS10. Researchers examined patient function, limited joints, and psychosocial health, as well as annual pain between 1-year and 5-year follow-up. The results were recently published in Arthritis & Rheumatology.

“Wallace’s preliminary criteria includes five components, observed or measured by a physician, which must all be absent or in the normal range, but do not include an assessment by the patient or their proxy,” Ms. Shoop-Worrall and her colleagues wrote. “In contrast, the JADAS and cJADAS include fewer overall components, meaning they may be easier to complete in a routine clinical setting, but do include a patient or proxy subjective assessment of patient wellbeing.”

Of the patients analyzed, 68% had oligoarthritis, while 27% had RF-negative and 5% had RF-positive polyarticular JIA. Over half (56%) of patients did not achieve CID, while 21% had achieved CID through both definitions. A further 23% of patients achieved CID in only one definition – 16% of patients according to cJADAS10 and 7% of patients according to Wallace’s preliminary criteria. Patients who achieved CID had significantly increased odds of having no limited joints according to either cJADAS10 (odds ratio, 3.9; 95% confidence interval, 2.5-6.3) or Wallace’s preliminary criteria (OR, 7.5; 95% CI, 2.9-19.2). Patients had better Child Health Questionnaire psychosocial scores when they achieved CID according to either cJADAS10 (coefficient, 5.3; 95% CI, 0.5-10.1) or both cJADAS10 and Wallace’s preliminary criteria (coefficient, 5.5; 95% CI, 2.2-9.5).

When patients’ function was assessed using the Childhood Health Assessment questionnaire, they had significantly increased odds of having no disability recorded when they achieved CID with either cJADAS10 (OR, 4.5; 95% CI, 2.2-9.5) or both criteria (OR 5.2; 95% CI, 2.7-9.9). Patients assessed with Wallace’s preliminary criteria had “no better Child Health Questionnaire psychosocial scores or Childhood Health Assessment questionnaire scores than those with active disease at 1 year.” Most patients who achieved CID also achieved MDA, but 10% of patients reached MDA without achieving CID.

 

The researchers noted that reliance on either cJADAS10 or Wallace’s preliminary criteria alone may miss data needed for clinical treatment. Data obtained from cJADAS10 may lead to additional psychological and physiotherapy treatments not seen in Wallace’s preliminary criteria; however, “relying solely on Wallace’s preliminary criteria may guide immunosuppressive therapy very well, but may ignore other symptoms relevant to the patient.”

“As the two scores differ in their components one could argue that they are not capturing the same construct,” Ms. Shoop-Worrall and her associates wrote. “Wallace’s preliminary criteria capture more objective measures of inflammation, whilst the cJADAS10, through inclusion of a patient well-being measure, may also capture other noninflammatory components of the disease, such as chronic pain and fatigue, not captured by Wallace’s preliminary criteria.”

The authors reported having no relevant financial disclosures for this study.

SOURCE: Shoop‐Worrall SJW et al. Arthritis Rheumatol. 2018 April 12. doi: 10.1002/art.40519.

 

Applying clinical Juvenile Arthritis Disease Activity Score criteria to identify clinically inactive disease in patients with juvenile idiopathic arthritis (JIA) resulted in patients with better long-term functional activity and psychosocial health outcomes, compared with patients whose disease state was assessed using Wallace’s preliminary criteria, according to recent research from the multicenter Childhood Arthritis Prospective Study.

“A challenge is in understanding how best to apply these results in the clinical setting,” wrote Stephanie J.W. Shoop-Worrall of the Arthritis Research UK Centre for Epidemiology at the University of Manchester (England) and her coauthors. “As achievement of CID [clinically inactive disease] according to cJADAS10 [clinical Juvenile Arthritis Disease Activity Score assessed in 10 joints] was associated with equivalent or superior outcomes to Wallace’s preliminary criteria and it is more feasible to complete in clinical practice, due to containing only three routinely collected components, one could argue that this is likely to be a superior treatment target for application in clinical practice.”

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Ms. Shoop-Worrall and her colleagues identified 832 children (70% female) from eight pediatric and adolescent rheumatology centers in the United Kingdom with rheumatoid factor (RF)–negative or –positive polyarticular JIA or oligoarthritis. The patients were enrolled in the study during 2001-2011 and were assessed for minimal disease activity (MDA) and CID states.

Investigators applied the cJADAS10 to determine MDA, while CID was assessed using both cJADAS10 and Wallace’s preliminary criteria at 1-year follow-up. Children were categorized based on whether they achieved CID according to cJADAS10 only, whether they did so according to Wallace’s preliminary criteria only, whether they did so according to both cJADAS10 and Wallace’s preliminary criteria, or whether they did not achieve CID according to either; they also were categorized based on whether they achieved MDA but not CID according to cJADAS10. Researchers examined patient function, limited joints, and psychosocial health, as well as annual pain between 1-year and 5-year follow-up. The results were recently published in Arthritis & Rheumatology.

“Wallace’s preliminary criteria includes five components, observed or measured by a physician, which must all be absent or in the normal range, but do not include an assessment by the patient or their proxy,” Ms. Shoop-Worrall and her colleagues wrote. “In contrast, the JADAS and cJADAS include fewer overall components, meaning they may be easier to complete in a routine clinical setting, but do include a patient or proxy subjective assessment of patient wellbeing.”

Of the patients analyzed, 68% had oligoarthritis, while 27% had RF-negative and 5% had RF-positive polyarticular JIA. Over half (56%) of patients did not achieve CID, while 21% had achieved CID through both definitions. A further 23% of patients achieved CID in only one definition – 16% of patients according to cJADAS10 and 7% of patients according to Wallace’s preliminary criteria. Patients who achieved CID had significantly increased odds of having no limited joints according to either cJADAS10 (odds ratio, 3.9; 95% confidence interval, 2.5-6.3) or Wallace’s preliminary criteria (OR, 7.5; 95% CI, 2.9-19.2). Patients had better Child Health Questionnaire psychosocial scores when they achieved CID according to either cJADAS10 (coefficient, 5.3; 95% CI, 0.5-10.1) or both cJADAS10 and Wallace’s preliminary criteria (coefficient, 5.5; 95% CI, 2.2-9.5).

When patients’ function was assessed using the Childhood Health Assessment questionnaire, they had significantly increased odds of having no disability recorded when they achieved CID with either cJADAS10 (OR, 4.5; 95% CI, 2.2-9.5) or both criteria (OR 5.2; 95% CI, 2.7-9.9). Patients assessed with Wallace’s preliminary criteria had “no better Child Health Questionnaire psychosocial scores or Childhood Health Assessment questionnaire scores than those with active disease at 1 year.” Most patients who achieved CID also achieved MDA, but 10% of patients reached MDA without achieving CID.

 

The researchers noted that reliance on either cJADAS10 or Wallace’s preliminary criteria alone may miss data needed for clinical treatment. Data obtained from cJADAS10 may lead to additional psychological and physiotherapy treatments not seen in Wallace’s preliminary criteria; however, “relying solely on Wallace’s preliminary criteria may guide immunosuppressive therapy very well, but may ignore other symptoms relevant to the patient.”

“As the two scores differ in their components one could argue that they are not capturing the same construct,” Ms. Shoop-Worrall and her associates wrote. “Wallace’s preliminary criteria capture more objective measures of inflammation, whilst the cJADAS10, through inclusion of a patient well-being measure, may also capture other noninflammatory components of the disease, such as chronic pain and fatigue, not captured by Wallace’s preliminary criteria.”

The authors reported having no relevant financial disclosures for this study.

SOURCE: Shoop‐Worrall SJW et al. Arthritis Rheumatol. 2018 April 12. doi: 10.1002/art.40519.

 

A new screening tool for detecting early psoriatic arthritis in patients with psoriasis that combined the “most discriminative questions” from several other questionnaires performed as well as the Psoriasis Epidemiology Screening Tool (PEST) for detecting the disease.

“The CONTEST questionnaire was developed using the best performing items from three other screening questionnaires in the hope that it would perform better than its originators,” Laura Coates, MBChB, PhD, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, England, and her coauthors wrote in the Journal of the European Academy of Dermatology and Venereology. “In development this was partly correct but the current study does not support this – statistically there was no difference between PEST and CONTEST in terms of ability to detect psoriatic arthritis [PsA] in patients with psoriasis.”

designer491/iStock/Getty Images

In an observational, cross-sectional study, Dr. Coates and her colleagues analyzed the rate of PsA in 159 patients with psoriasis from November 2013 to March 2017 at four different secondary care dermatology centers in Leeds, Bath, Bradford, and Salford in England. (At the time of the study, Dr. Coates was a visiting rheumatologist at the Leeds Institute of Rheumatic and Musculoskeletal Medicine.) Patients were a minimum of 18 years old, did not have a diagnosis of inflammatory joint disease, and had a mean age of 29 years at diagnosis of psoriasis. The patients completed the Psoriatic Arthritis Quality of Life questionnaire, Health Assessment Questionnaire, and Dermatology Life Quality Index, as well as the CONTEST and PEST questionnaires. Patients were assessed by a dermatologist to determine psoriasis type and medication, and then were seen by a rheumatologist to determine whether they had PsA, a different musculoskeletal disease, or no musculoskeletal disease.

The researchers found 27 patients (17%; 95% confidence interval, 12.3%-21.7%) with previously undiagnosed PsA, 71 with a different musculoskeletal disease, and 61 without musculoskeletal disease. Patients with PsA tended to be male, older, with “worse functional ability,” a similar age at onset of psoriasis, and had similar skin and nail disease severity. The sensitivity for PEST was 0.60 (95% CI, 0.42-0.78) and the specificity was 0.76 (95% CI, 0.69-0.83), while for CONTEST, the sensitivity was 0.53 (95% CI, 0.34-0.72) and the specificity was 0.71 (95% CI, 0.63-0.79). The area under the receiver operating curve confidence intervals for both screening tools were similar, with PEST having an AUC of 0.72 (95% CI, 0.61-0.84) and CONTEST having an AUC of 0.66 (95% CI, 0.54-0.77).

“The relative simplicity of the PEST questionnaire has raised concerns that the tool is not able to detect pure axial forms of the disease,” Dr. Coates and her colleagues wrote. “The CONTEST questionnaire includes items specific to back and neck pain, and so it was hoped it would better detect this subgroup. In this study this is not the case, although the numbers were small and imaging of the spine was not part of the study.”

 

AbbVie supported this study with an educational grant. The study was supported by the National Institute for Health Research Leeds Biomedical Research Centre. Some of the authors reported potential conflicts of interest.

SOURCE: Coates L et al. J Eur Acad Dermatol Venereol. 2018 Mar 26. doi: 10.1111/jdv.14971.

 

A new screening tool for detecting early psoriatic arthritis in patients with psoriasis that combined the “most discriminative questions” from several other questionnaires performed as well as the Psoriasis Epidemiology Screening Tool (PEST) for detecting the disease.

“The CONTEST questionnaire was developed using the best performing items from three other screening questionnaires in the hope that it would perform better than its originators,” Laura Coates, MBChB, PhD, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, England, and her coauthors wrote in the Journal of the European Academy of Dermatology and Venereology. “In development this was partly correct but the current study does not support this – statistically there was no difference between PEST and CONTEST in terms of ability to detect psoriatic arthritis [PsA] in patients with psoriasis.”

designer491/iStock/Getty Images

In an observational, cross-sectional study, Dr. Coates and her colleagues analyzed the rate of PsA in 159 patients with psoriasis from November 2013 to March 2017 at four different secondary care dermatology centers in Leeds, Bath, Bradford, and Salford in England. (At the time of the study, Dr. Coates was a visiting rheumatologist at the Leeds Institute of Rheumatic and Musculoskeletal Medicine.) Patients were a minimum of 18 years old, did not have a diagnosis of inflammatory joint disease, and had a mean age of 29 years at diagnosis of psoriasis. The patients completed the Psoriatic Arthritis Quality of Life questionnaire, Health Assessment Questionnaire, and Dermatology Life Quality Index, as well as the CONTEST and PEST questionnaires. Patients were assessed by a dermatologist to determine psoriasis type and medication, and then were seen by a rheumatologist to determine whether they had PsA, a different musculoskeletal disease, or no musculoskeletal disease.

The researchers found 27 patients (17%; 95% confidence interval, 12.3%-21.7%) with previously undiagnosed PsA, 71 with a different musculoskeletal disease, and 61 without musculoskeletal disease. Patients with PsA tended to be male, older, with “worse functional ability,” a similar age at onset of psoriasis, and had similar skin and nail disease severity. The sensitivity for PEST was 0.60 (95% CI, 0.42-0.78) and the specificity was 0.76 (95% CI, 0.69-0.83), while for CONTEST, the sensitivity was 0.53 (95% CI, 0.34-0.72) and the specificity was 0.71 (95% CI, 0.63-0.79). The area under the receiver operating curve confidence intervals for both screening tools were similar, with PEST having an AUC of 0.72 (95% CI, 0.61-0.84) and CONTEST having an AUC of 0.66 (95% CI, 0.54-0.77).

“The relative simplicity of the PEST questionnaire has raised concerns that the tool is not able to detect pure axial forms of the disease,” Dr. Coates and her colleagues wrote. “The CONTEST questionnaire includes items specific to back and neck pain, and so it was hoped it would better detect this subgroup. In this study this is not the case, although the numbers were small and imaging of the spine was not part of the study.”

 

AbbVie supported this study with an educational grant. The study was supported by the National Institute for Health Research Leeds Biomedical Research Centre. Some of the authors reported potential conflicts of interest.

SOURCE: Coates L et al. J Eur Acad Dermatol Venereol. 2018 Mar 26. doi: 10.1111/jdv.14971.

 

A new screening tool for detecting early psoriatic arthritis in patients with psoriasis that combined the “most discriminative questions” from several other questionnaires performed as well as the Psoriasis Epidemiology Screening Tool (PEST) for detecting the disease.

“The CONTEST questionnaire was developed using the best performing items from three other screening questionnaires in the hope that it would perform better than its originators,” Laura Coates, MBChB, PhD, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, England, and her coauthors wrote in the Journal of the European Academy of Dermatology and Venereology. “In development this was partly correct but the current study does not support this – statistically there was no difference between PEST and CONTEST in terms of ability to detect psoriatic arthritis [PsA] in patients with psoriasis.”

designer491/iStock/Getty Images

In an observational, cross-sectional study, Dr. Coates and her colleagues analyzed the rate of PsA in 159 patients with psoriasis from November 2013 to March 2017 at four different secondary care dermatology centers in Leeds, Bath, Bradford, and Salford in England. (At the time of the study, Dr. Coates was a visiting rheumatologist at the Leeds Institute of Rheumatic and Musculoskeletal Medicine.) Patients were a minimum of 18 years old, did not have a diagnosis of inflammatory joint disease, and had a mean age of 29 years at diagnosis of psoriasis. The patients completed the Psoriatic Arthritis Quality of Life questionnaire, Health Assessment Questionnaire, and Dermatology Life Quality Index, as well as the CONTEST and PEST questionnaires. Patients were assessed by a dermatologist to determine psoriasis type and medication, and then were seen by a rheumatologist to determine whether they had PsA, a different musculoskeletal disease, or no musculoskeletal disease.

The researchers found 27 patients (17%; 95% confidence interval, 12.3%-21.7%) with previously undiagnosed PsA, 71 with a different musculoskeletal disease, and 61 without musculoskeletal disease. Patients with PsA tended to be male, older, with “worse functional ability,” a similar age at onset of psoriasis, and had similar skin and nail disease severity. The sensitivity for PEST was 0.60 (95% CI, 0.42-0.78) and the specificity was 0.76 (95% CI, 0.69-0.83), while for CONTEST, the sensitivity was 0.53 (95% CI, 0.34-0.72) and the specificity was 0.71 (95% CI, 0.63-0.79). The area under the receiver operating curve confidence intervals for both screening tools were similar, with PEST having an AUC of 0.72 (95% CI, 0.61-0.84) and CONTEST having an AUC of 0.66 (95% CI, 0.54-0.77).

“The relative simplicity of the PEST questionnaire has raised concerns that the tool is not able to detect pure axial forms of the disease,” Dr. Coates and her colleagues wrote. “The CONTEST questionnaire includes items specific to back and neck pain, and so it was hoped it would better detect this subgroup. In this study this is not the case, although the numbers were small and imaging of the spine was not part of the study.”

 

AbbVie supported this study with an educational grant. The study was supported by the National Institute for Health Research Leeds Biomedical Research Centre. Some of the authors reported potential conflicts of interest.

SOURCE: Coates L et al. J Eur Acad Dermatol Venereol. 2018 Mar 26. doi: 10.1111/jdv.14971.

 

Recent data suggest the longer a patient with polyarticular forms of juvenile idiopathic arthritis stays on anti–tumor necrosis factor therapy to maintain a clinical inactive disease state, the higher the likelihood of experiencing disease flare after discontinuing anti-TNF therapy.

Daniel J. Lovell, MD, MPH, of the Cincinnati Children’s Hospital Medical Center, and his coauthors prospectively evaluated 137 patients with clinical inactive PF-JIA who were receiving anti-TNF therapy at 16 academic pediatric centers. Of these, 7 patients dropped from the study and 24 patients did not maintain clinical inactive disease (CID) for 6 months.

“CID was an unstable state and 18.5% of the patients were unable to maintain CID for 6 continuous months of observation, even while continuing to receive the anti-TNF agent and stable doses of all background medications,” Dr. Lovell and his colleagues wrote in their study, published in Arthritis & Rheumatology.

Among the 106 patients who continued anti-TNF therapy for 6 months and maintained CID, the investigators then stopped anti-TNF therapy and examined patients for disease flare at 1-month, 2-month, 3-month, 4-month, 6-month, and 8-month follow-up. A total of 42% of these patients were also taking background medication such as methotrexate. Investigators found 39 patients (37%) who showed signs of disease flare within 8 months of discontinuing anti-TNF therapy. A number of factors proved to be significantly associated with disease flare, including age at disease onset (hazard ratio, 0.92; 95% confidence interval, 0.85-0.99; P = .03), age at disease diagnosis (HR, 0.91; 95% CI, 0.84-0.99; P = .02), disease duration at enrollment (HR, 1.12; 95% CI, 1.04-1.21; P less than .01) and time from onset until first CID (HR, 1.10; 95% CI, 1.01-1.20; P = .04). Flare occurred at a mean 7.01 months (standard error of the mean, 0.32) and median 8.26 months (95% CI, 7.80-8.66).

“These data certainly do not support the existence of a protective effect of longer duration of CID before considering stopping anti-TNF therapy,” the authors wrote in their study. “In fact, the data suggest that CID, even in those who did demonstrate CID consistently for the first 6 months of the study, continued to be an unstable clinical state and prolonged observation of CID resulted in a significantly greater risk for flare.”

Dr. Lovell and his colleagues noted their results suggest a “window of opportunity” where treating JIA early with “aggressive therapy” to reach CID sooner will help improve outcomes and long-term control of the disease.

The study was sponsored by a grant from the National Institutes of Health.

SOURCE: Lovell D et al. Arthritis Rheumatol. 2018 Mar 31. doi: 10.1002/art.40509.

 

Recent data suggest the longer a patient with polyarticular forms of juvenile idiopathic arthritis stays on anti–tumor necrosis factor therapy to maintain a clinical inactive disease state, the higher the likelihood of experiencing disease flare after discontinuing anti-TNF therapy.

Daniel J. Lovell, MD, MPH, of the Cincinnati Children’s Hospital Medical Center, and his coauthors prospectively evaluated 137 patients with clinical inactive PF-JIA who were receiving anti-TNF therapy at 16 academic pediatric centers. Of these, 7 patients dropped from the study and 24 patients did not maintain clinical inactive disease (CID) for 6 months.

“CID was an unstable state and 18.5% of the patients were unable to maintain CID for 6 continuous months of observation, even while continuing to receive the anti-TNF agent and stable doses of all background medications,” Dr. Lovell and his colleagues wrote in their study, published in Arthritis & Rheumatology.

Among the 106 patients who continued anti-TNF therapy for 6 months and maintained CID, the investigators then stopped anti-TNF therapy and examined patients for disease flare at 1-month, 2-month, 3-month, 4-month, 6-month, and 8-month follow-up. A total of 42% of these patients were also taking background medication such as methotrexate. Investigators found 39 patients (37%) who showed signs of disease flare within 8 months of discontinuing anti-TNF therapy. A number of factors proved to be significantly associated with disease flare, including age at disease onset (hazard ratio, 0.92; 95% confidence interval, 0.85-0.99; P = .03), age at disease diagnosis (HR, 0.91; 95% CI, 0.84-0.99; P = .02), disease duration at enrollment (HR, 1.12; 95% CI, 1.04-1.21; P less than .01) and time from onset until first CID (HR, 1.10; 95% CI, 1.01-1.20; P = .04). Flare occurred at a mean 7.01 months (standard error of the mean, 0.32) and median 8.26 months (95% CI, 7.80-8.66).

“These data certainly do not support the existence of a protective effect of longer duration of CID before considering stopping anti-TNF therapy,” the authors wrote in their study. “In fact, the data suggest that CID, even in those who did demonstrate CID consistently for the first 6 months of the study, continued to be an unstable clinical state and prolonged observation of CID resulted in a significantly greater risk for flare.”

Dr. Lovell and his colleagues noted their results suggest a “window of opportunity” where treating JIA early with “aggressive therapy” to reach CID sooner will help improve outcomes and long-term control of the disease.

The study was sponsored by a grant from the National Institutes of Health.

SOURCE: Lovell D et al. Arthritis Rheumatol. 2018 Mar 31. doi: 10.1002/art.40509.

 

Recent data suggest the longer a patient with polyarticular forms of juvenile idiopathic arthritis stays on anti–tumor necrosis factor therapy to maintain a clinical inactive disease state, the higher the likelihood of experiencing disease flare after discontinuing anti-TNF therapy.

Daniel J. Lovell, MD, MPH, of the Cincinnati Children’s Hospital Medical Center, and his coauthors prospectively evaluated 137 patients with clinical inactive PF-JIA who were receiving anti-TNF therapy at 16 academic pediatric centers. Of these, 7 patients dropped from the study and 24 patients did not maintain clinical inactive disease (CID) for 6 months.

“CID was an unstable state and 18.5% of the patients were unable to maintain CID for 6 continuous months of observation, even while continuing to receive the anti-TNF agent and stable doses of all background medications,” Dr. Lovell and his colleagues wrote in their study, published in Arthritis & Rheumatology.

Among the 106 patients who continued anti-TNF therapy for 6 months and maintained CID, the investigators then stopped anti-TNF therapy and examined patients for disease flare at 1-month, 2-month, 3-month, 4-month, 6-month, and 8-month follow-up. A total of 42% of these patients were also taking background medication such as methotrexate. Investigators found 39 patients (37%) who showed signs of disease flare within 8 months of discontinuing anti-TNF therapy. A number of factors proved to be significantly associated with disease flare, including age at disease onset (hazard ratio, 0.92; 95% confidence interval, 0.85-0.99; P = .03), age at disease diagnosis (HR, 0.91; 95% CI, 0.84-0.99; P = .02), disease duration at enrollment (HR, 1.12; 95% CI, 1.04-1.21; P less than .01) and time from onset until first CID (HR, 1.10; 95% CI, 1.01-1.20; P = .04). Flare occurred at a mean 7.01 months (standard error of the mean, 0.32) and median 8.26 months (95% CI, 7.80-8.66).

“These data certainly do not support the existence of a protective effect of longer duration of CID before considering stopping anti-TNF therapy,” the authors wrote in their study. “In fact, the data suggest that CID, even in those who did demonstrate CID consistently for the first 6 months of the study, continued to be an unstable clinical state and prolonged observation of CID resulted in a significantly greater risk for flare.”

Dr. Lovell and his colleagues noted their results suggest a “window of opportunity” where treating JIA early with “aggressive therapy” to reach CID sooner will help improve outcomes and long-term control of the disease.

The study was sponsored by a grant from the National Institutes of Health.

SOURCE: Lovell D et al. Arthritis Rheumatol. 2018 Mar 31. doi: 10.1002/art.40509.