Definitions of outcomes and adverse events reported in trials of antibiotic treatment for reactive arthritis.
| Author | Definition of Remission | Secondary Outcomes Measured | Adverse Events | Study Followup (mos) |
|---|---|---|---|---|
| Astrauskiene17 | No sign of disease activity | NA | Not specified a priori. Reported gsatrointestinal and skin reactions | 3 |
| Carter7 | Patient reported belief that their disease went into complete remission | TJC SJC | Predefined as any new medical diagnosis or condition, serious adverse events if resulting in hospitalization, IV antibiotics or death. Reported: nausea, abdominal pain, diarrhea, GERD, arthralgia, rash, viral/upper respiratory infection, vaginal candidiasis | 9 |
| Fryden18 | NA | NA | NR | 18 |
| Hoogkamp-Korstanje19 | Complete remission of arthritis | Ritchie’s Articular Index* (12); Pain* (VAS 0–10) | NR | 12 |
| Kvien9 | NA | TJC SJC Patient Global Assessment (severity scale 1–5) Joint pain (severity scale 1–5) | A priori screening for adverse drug reactions and intercurrent illness at each visit. Reported: gastrointestinal, fungal infections, respiratory, cutaneous, stomatitis, neurological, headache, urogenital, laboratory abnormalities, miscellaneous | 6 |
| Lauhio20 | Normal clinical exam, normal ESR, CRP, and WBC and absence of subjective symptoms | NA | Not specified a priori. Reported: allergic skin reaction, photosensitivity, nausea, abdominal pain, loose stool, diarrhea with negative stool cultures, positive C. difficile asymptomatic, diarrhea with positive C. difficile | 6 |
| Putschky8 | Defined by 1981 ACR criteria for remission in RA | SJC TJC Patient Global Assessment Pain VAS (0–10) | NR | 4 |
| Sieper21 | No joint pain at rest, no swelling, mild tenderness (grade 1, as defined in the Articular index score) at most, normal CRP level and no relapse of arthritis (after remission) since the start of the study. | Ritchie’s Articular Index (12)*** | Adverse events monitored at 1, 2, and 3 months with tests to monitor bone marrow, liver and kidney. Reported: mild abdominal symptoms (including diarrhea, constipation, abdominal pain and nausea and vomiting), mild neurologic symptoms (including headache, paresthesias, depression and sleeplessness), fatigue and dizziness and other miscellaneous symptoms (not included in meta-analysis as could not isolate subgroup with definite reactive arthritis) | 12 (Primary analysis reported at 3 months) |
| Smieja22 | NA | NA | Not specified a priori. Reported photosensitivity, esophagitis gastric upset, flare or arthritis, hepatitis (not included in meta-analysis as could not isolate subgroup with definite reactive arthritis) | 12 (primary analysis reported at 3 months) |
| Toivavev23 | NA | Joint swelling (Scored 0–3) Ritchie’s articular index (12) Patient global (VAS 0–10) Pain at movement (VAS 0–10) | Not specified a priori. Reported: rash and malaise | 9 |
| Wakefield24 | NA | Number of joints** | Not specified a priori. Number but not type of adverse reaction reported as reasons for withdrawal from study, unclear if there were other adverse events that did not lead to withdrawal | 24 Clinical severity compared at 6 months and relapse at 1 year |
| Yli-Kerttula25 | Complete recovery not otherwise specified assessment | SJC Ritchie’s articular index (12) Patient global (VAS 0–100) | Unclear if specified a priori. Reported: microscopic hematuria and hospitalization for prolonged fever and arthritis as severe events. Other adverse events reported: abdominal, infections, nervous system, skin reactions, miscellaneous | 12 |
↵* Ritchie’s articular index and pain scores reported in this trial could not be pooled with other tender joint counts because no standard errors were reported in the study.
↵** Reported on total joint count without specifying whether it was a swollen or tender joint count, and we included this in the analysis of the former.
↵*** Unable to pool because of format and lack of data CRP: C-reactive protein; ESR: erythrocyte sedimentation rate; GERD: gastroesophageal reflux disease; IV: intravenous; NR: not reported; NA: not applicable; SJC: swollen joint count; TJC: tender joint count; VAS: visual analog scale; WBC: white blood cell count.