Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study.

INTRODUCTION: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. PATIENTS AND METHODS: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks' CZP versus 2 years pre-baseline. RESULTS: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12-0.28), p < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. CONCLUSION: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. TRIAL REGISTRATION CLINICALTRIALSGOV: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992.

Sex and gender differences in axial spondyloarthritis: myths and truths.

Mounting evidence reveals evident sex differences in physiology, disease presentation and response to medication in axial SpA (axSpA). Unfortunately these data are often neglected in clinical practice and research. In this review, myths that still exist on diagnosis, disease manifestation and drug effectiveness were argued against data of the most recent literature. The aim is to increase awareness of sex differences in the clinical aspects of axSpA.

Axial Spondyloarthritis in the Era of Precision Medicine.

In axial spondyloarthritis (axSpA), the first treatment step is generally a nonsteroidal anti-inflammatory drug, and if insufficient, a biologic is added. Currently, most evidence is available of the biologic tumor necrosis factor-α inhibitors. In patients who have achieved sustained low disease activity, tumor necrosis factor-α inhibitor tapering is considered, although standardized tapering schedules are lacking. In axSpA patients with extra-articular manifestations, the effect of axSpA treatment on these extra-articular manifestations is important to determine the preferred therapy. Overall, it is recommended that treatment of axSpA be individualized based on the most prominent symptoms and presence of extra-articular and peripheral symptoms.

Patients with axial spondyloarthritis report significant differences between men and women and high impact of the disease: Large websurvey analysis.

OBJECTIVE: In axial spondyloarthritis (axSpA), mounting evidence shows female patients to experience a higher disease burden. These differences appear to be particularly large in South America. One explanation could be inequity in treatment access between men and women. The objective was to evaluate gender differences in disease burden and work participation, and the potential influence of treatment, in Latin American patients. METHODS: A cross sectional online survey among axSpA patients, collecting disease characteristics, treatment, disease burden (BASDAI, BASFI, ASAS Health Index) and work participation (WPAI). Associations between gender and disease burden or work participation were assessed through regression analyses, correcting for treatment. RESULTS: AxSpA was reported by 472 participants (63% women) and disease activity (BASDAI≥4: 83%), ASASHI (≥moderately impaired: 91%) and work disability (absenteeism: 41%; presenteeism 82%) were high. Biological use was very low (20%), while 34% used opiates. Females had significantly higher BASDAI, ASAS HI, work absenteeism and presenteeism, although were less likely to receive biologics (26% versus 16%, P<0.01). Gender differences disappeared after correction for treatment. CONCLUSIONS: This web survey in Latin American axSpA patients shows a high disease burden and work impairment. The use of biologics is low, while the use of opiates was alarmingly high. Women used significantly less biologics despite reporting a worse disease state and work disability, which could be due to treatment inequity.

The Ankylosing Spondylitis Performance Index: Reliability and Feasibility of an Objective Test for Physical Functioning.

OBJECTIVE: Physical function in patients with axial spondyloarthritis (axSpA) is currently evaluated through questionnaires. The Ankylosing Spondylitis Performance Index (ASPI) is a performance-based measure for physical functioning, which has been validated in Dutch patients with radiographic (r-) axSpA. The interrater reliability has not yet been determined. To our knowledge, this study is the first to evaluate the validity, reliability, and feasibility of the ASPI in another patient population, including both r- and nonradiographic (nr-) axSpA patients. METHODS: Patients with axSpA were recruited from rheumatology clinics in Santiago, Chile. Dutch instructions were translated to Spanish by a forward-backward procedure. Study visits were performed at baseline and 1-4 weeks later. Four ASPI observers were involved, measuring the performance times of the 3 ASPI tests. Validity was assessed through a patient questionnaire (numeric rating scale 0-10: ≥ 6 sufficient). For reliability, intraclass correlation coefficients (ICC) were calculated (with 95% CI). Correlations between the ASPI and disease variables were tested with regression analyses. RESULTS: Sixty-eight patients were included (57% male, 52% r-axSpA). All patients understood the Spanish instructions and considered the ASPI to reach its aim (84%) and representativeness (85%) for physical functioning. The overall interrater (n = 62) and test-retest (n = 39) reliability (ICC) of the 3 tests combined were 0.93 (0.88-0.96) and 0.94 (0.87-0.97), respectively. Eighty-two percent of the patients completed all tests and 94% finished in < 15 min (feasibility). CONCLUSION: This study demonstrated a high validity and feasibility in an entirely different population, with both r-axSpA and nr-axSpA. The interrater and test-retest reliability was excellent. The ASPI instructions are now available for Spanish-speaking patients.

Reduced Occurrence Rate of Acute Anterior Uveitis in Ankylosing Spondylitis Treated with Golimumab - The GO-EASY Study.

OBJECTIVE: Acute anterior uveitis (AAU) is common in ankylosing spondylitis (AS). Golimumab (GOL), a tumor necrosis factor-α inhibitor (TNFi), has proven to be effective in the treatment of AS. To date, the effect of GOL on the incidence of AAU in AS is unknown. The objective was to study the AAU occurrence rate in patients with AS during GOL treatment and secondarily, the efficacy of GOL in daily clinical practice. METHODS: The study was a multicenter prospective study in a real-world setting in patients with AS who were treated with GOL for 12 months. The occurrence of AAU was assessed in the year before the initial TNFi treatment and during GOL treatment and calculated for the period at risk for a new AAU. Measures for disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)] and treatment response [Assessment of Spondyloarthritis international Society (ASAS20 score)] were collected. RESULTS: In total, 93 patients (65% male, 55% TNFi-naive, 27% history of AAU) were included, with a median disease duration of 7 years and ASDAS score of 3.1. During GOL treatment, the AAU occurrence rate was reduced from 11.1 to 2.2 per 100 patient-years (rate-ratio 0.20, 95% CI 0.04-0.91). After 3 months of treatment, 41% of the patients experienced a clinically important improvement of the ASDAS score (p < 0.001) and 36% an ASDAS20 response (p < 0.001). At month 12, 49% had achieved an ASAS20 response (p < 0.001). CONCLUSION: In AS, the AAU occurrence rate and disease activity decreased significantly during GOL treatment. Therefore, GOL can be considered a good choice in patients with AS who need a TNFi, especially in cases of recurrent AAU. (EudraCT number: 2012-002458-21).