| Literature DB >> 35079380 |
Xenofon Baraliakos1, Styliani Tsiami1, Sooraj Vijayan2,3, Haewon Jung4, Nick Barkham2.
Abstract
The COVID-19 pandemic highlighted the benefits of subcutaneous (SC) administration for healthcare systems. The first SC infliximab, CT-P13 SC, was safe and effective for the treatment of psoriatic arthritis. Observed patient preferences for continuing CT-P13 SC suggest that patients receiving IV infliximab should be offered a switch to CT-P13 SC.Entities:
Keywords: COVID‐19; CT‐P13 SC; infliximab SC; infliximab subcutaneous; psoriatic arthritis; real‐world evidence
Year: 2022 PMID: 35079380 PMCID: PMC8777045 DOI: 10.1002/ccr3.5205
Source DB: PubMed Journal: Clin Case Rep ISSN: 2050-0904
Patient demographics, treatment history and disease activity
| Patient # | Sex | Age, years | Body weight, kg | Year of PsA diagnosis | Prior treatment | CT‐P13 treatment | Disease activity | Safety | |
|---|---|---|---|---|---|---|---|---|---|
| Prior to CT‐P13 SC (120 mg Q2W) | At follow‐up | ||||||||
| 1 | Male | 40 | 92 | 2012 |
MTX Adalimumab |
Initiated infliximab with CT‐P13 SC Continuing CT‐P13 SC at last follow‐up |
BSA: 24%; clear scaly psoriasiform plaques on head, ears, hands, elbows, knee joints, groin, and gluteal area, and nail PsO of fingernails Pain in cervical spine and thoracolumbar area, radiating into gluteal area and groin Arthralgia in hands, fingers, and knees; right knee joint effusion, minor generalized synovitis, and hypertrophic synovialitic nodule (lateral parapatellar) requiring corticosteroid infiltration Fist closing possible, with painful pressure at MCP joints II to V and PIP joints III and V (right hand) and MCP joints II to III (left hand) CRP: 2.1 mg/dl ESR: 36 mm/h Uric acid: 9.5 mg/dl |
BSA: 10%; improved skin PsO on head, elbows, and knees No joint tenderness, synovitic swelling of joints, or axial pain CRP: 0.2 mg/dl ESR: 7 mm/h | No side effects reported by patient |
| 2 | Female | 53 | 94 | 2017 |
Sulfasalazine Etanercept Ustekinumab |
Initiated infliximab with CT‐P13 SC Continuing CT‐P13 SC at last follow‐up |
BSA: 45%; PsO plaques on hands, ears, groin, and lower legs, with nail PsO of all fingernails Pain in hands, fingers, elbows, lumbar spine, and greater trochanters bilaterally Swelling of right MCP joint III with pain upon pressure Achillodynia and swelling with thickened and clearly signal‐elevated Achilles tendon (distal third), with peritendinitis and clear bursitis subachillae requiring cortisone infiltration to the left ankle Inflammatory markers: Not elevated |
BSA: <10%; regressive PsO plaques on the hands, ears, and groin No pressure pain or synovitic joint swelling; no enthesitis | No side effects reported by patient |
| 3 | Male | 64 | 82 | 2019 |
Leflunomide CT‐P13 IV |
Switched from CT‐P13 IV to CT‐P13 SC Continuing CT‐P13 SC at last follow‐up |
BSA: 5%, with medium‐sized scaly skin lesions of both elbows and sporadically over the thighs Arthralgia of both hands and fingers; swelling in the carpal area; swelling of PIP joint II and MCP joint III in the left hand; dactylitis of the left index finger; pressure pain of MTP joints III and IV in the left foot CRP: 6.9 mg/dl Creatinine: 1.3 mg/dl | BSA: 0% | Slight reddening at the injection site (first 2 SC administrations) |
| 4 | Male | 40 | 85 | 2003 |
MTX Infliximab IV CT‐P13 IV |
Switched from CT‐P13 IV to CT‐P13 SC Continuing CT‐P13 SC at last follow‐up |
DAS28: 0.77 VAS pain: 20 CRP: <0.1 mg/dL |
Improvement in symptoms CRP: 0.02 mg/dL | No side effects reported by patient |
| 5 | Female | 26 | 65 | 2016 |
Hydroxychloroquine MTX CT‐P13 IV +MTX |
Switched from CT‐P13 IV to CT‐P13 SC Continuing CT‐P13 SC at last follow‐up |
DAS28: 3.15 VAS pain: 30 TJC: 3/28 (9/78 prior to CT‐P13 IV initiation) SJC: 2/28 (14/76 prior to CT‐P13 IV initiation) CRP: <0.1 mg/dl ESR: 7 mm/h Prior to initiation of CT‐P13 IV, patient's VAS was 3/5 and physicians’ VAS was 3/5 |
No disease flares CRP: <0.02 mg/dl | No side effects reported by patient |
| 6 | Female | 36 | 85 | 2014 |
Leflunomide CT‐P13 IV +MTX |
Switched from CT‐P13 IV to CT‐P13 SC Continuing CT‐P13 SC at last follow‐up |
Physician's global VAS: 1/5 Patient's global VAS: 1/5 |
Patient's global VAS: 1/5 CRP: 0.1or 0.2 mg/dl | No side effects reported by patient |
| 7 | Male | 57 | 104 | 2017 |
Infliximab IV CT‐P13 IV |
Switched from CT‐P13 IV to CT‐P13 SC Continuing CT‐P13 SC at last follow‐up |
Physician's global VAS: 1/5 Patient's global VAS: 0/5 | CRP: 0.3 mg/dL | No side effects reported by patient |
| 8 | Female | 57 | 81 | 2008 |
Adalimumab Infliximab IV + MTX + leflunomide CT‐P13 IV + MTX + leflunomide |
Switched from CT‐P13 IV to CT‐P13 SC Switched back to CT‐P13 IV |
DAS28: 2.74 VAS pain: 35 | CRP: 0.2 mg/dl |
Mild bruising post‐injection No serious adverse events reported by patient |
| 9 | Male | 45 | 101 | Prior to 2003 |
MTX Infliximab IV CT‐P13 IV |
Switched from CT‐P13 IV to CT‐P13 SC Switched back to CT‐P13 IV |
Physician's global VAS: 2/5 Patient's global VAS: 2/5 |
Physician's global VAS: 3/5 Patient's global VAS: 4/5 CRP: 0.4 mg/dl |
Needle phobia developed No serious adverse events reported by patient |
| 10 | Male | 78 | 79 | Prior to 2003 |
Infliximab IV CT‐P13 IV |
Switched from CT‐P13 IV to CT‐P13 SC Switched back to CT‐P13 IV |
DAS28: 3.62 VAS pain: 50 | CRP: 0.1 mg/dl | No serious adverse events reported by patient |
Normal range cut‐offs for laboratory parameters were: creatinine, 0.7–1.2 mg/dl; CRP, 0.5 mg/dl; ESR, 20 mm/h; uric acid, 7.0 mg/dl.
Abbreviations: BSA, body surface area; CRP, C‐reactive protein; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; IV, intravenous; MCP, metacarpophalangeal; MTP, metatarsophalangeal; MTX, methotrexate; PIP, proximal interphalangeal; PsA, psoriatic arthritis; PsO, psoriasis; Q2W, every 2 weeks; SC, subcutaneous; SJC, swollen joint count; TJC, tender joint count; VAS, Visual Analog Scale.
CT‐P13 SC treatment characteristics
| Patient # | Body weight, kg | CT‐P13 SC | Duration of follow‐up on CT‐P13 SC treatment, months |
|---|---|---|---|
| 1 | 92 | 7 | 5.00 |
| 2 | 94 | 9 | 6.00 |
| 3 | 82 | 10 | 5.00 |
| 4 | 85 | 30 | 13.26 |
| 5 | 65 | 31 | 13.26 |
| 6 | 85 | 30 | 13.26 |
| 7 | 104 | 31 | 13.89 |
| 8 | 81 | 3 | 4.23 |
| 9 | 101 | 5 | 4.33 |
| 10 | 79 | 4 | 2.18 |
| Total number (median [range]) | N/A |
160 (9.5 [3–31]) |
80.41 (5.50 [2.18–13.89]) |
Abbreviations: N/A, not applicable; SC, subcutaneous.
All patients were scheduled to administer 120 mg CT‐P13 SC every 2 weeks.
Calculated from the date of CT‐P13 SC initiation (where this differed from the date of prescription).
Mean SIAQ domain scores for Patients 4–10
| Patient # | SIAQ domain mean scores | |||||
|---|---|---|---|---|---|---|
| Feelings about self‐injection | Self‐confidence | Self‐image | Satisfaction with self‐injection | Pain and skin reactions during or after injection | Ease of use of the self‐injection device | |
| Patients who decided to continue CT‐P13 SC | ||||||
| 4 | 10 | 10 | 10 | 9 | 7 | 10 |
| 5 | 5 | 10 | 10 | 6 | 10 | 10 |
| 6 | 5 | 10 | 10 | 10 | 6 | 10 |
| 7 | 5 | 10 | 9 | 10 | 6 | 10 |
| Mean (SD) | 6.25 (2.17) | 10.00 (0.00) | 9.75 (0.43) | 8.75 (1.64) | 7.25 (1.64) | 10.00 (0.00) |
| Patients who decided to switch back to CT‐P13 IV | ||||||
| 8 | 5 | 4 | 3 | 5 | 8 | 5 |
| 9 | 9 | 8 | 5 | 10 | 9 | 10 |
| 10 | 8 | 5 | 6 | 7 | 8 | 3 |
| Mean (SD) | 7.33 (1.70) | 5.67 (1.70) | 4.67 (1.25) | 7.33 (2.05) | 8.33 (0.47) | 6.00 (2.94) |
Abbreviations: IV, intravenous; SC, subcutaneous; SD, standard deviation; SIAQ, Self‐Injection Assessment Questionnaire.
Scored on a 10‐point scale from 0 (worst experience) to 10 (best experience).