Myasthenia Gravis Monitoring
Real-world data collection for AChR-positive generalized MG patients on biologic therapy — capturing fatigable weakness, bulbar safety, infusion cycles, and daily functional status.
Study Overview
About this study
Myasthenia gravis presents a distinctive real-world data challenge: symptoms are variable by the hour, worsened by exertion, and rarely captured at peak severity during clinic visits. The Forma Health Log App is configured for voice-first, in-the-moment reporting by patients and caregivers — capturing the fatigability patterns, bulbar safety events, and biologic treatment responses that diary studies and retrospective charts miss entirely. This configuration targets generalized, AChR-positive patients on approved biologics (efgartigimod, eculizumab, ravulizumab, rozanolixizumab, nipocalimab, zilucoplan) and bridges the gap between MG-ADL composite scores and the granular daily data needed for regulatory-grade real-world evidence.
What's included
Key features
- Voice-first logging of fatigable weakness with body region and rest-recovery tracking
- Bulbar safety monitoring with dedicated choking, aspiration, and nasal regurgitation flags
- Full biologic infusion cycle tracking across all approved MG therapies with reaction capture
- MG-ADL composite daily assessment scoring all 8 functional domains (0–3 each)
- Respiratory crisis early warning indicators including speech impact and orthopnea
- AChR and MuSK antibody titer tracking alongside complement and IgG biomarker monitoring
- Fatigue burden capture distinct from specific muscle weakness — with energy impact attribution
- Pyridostigmine and immunosuppressant side effect tracking with cholinergic symptom capture
Topic Configuration
Configured topics
Each study includes pre-configured topics that patients interact with daily. Here are examples of how we've set up data collection for this study.
Bulbar Function
Track swallowing, speech, and chewing on MG-ADL-aligned 0–3 scales with dedicated safety flags for choking, aspiration, and nasal regurgitation.
Sample questions
- How severe is the swallowing difficulty today?
- How is speech quality — nasal or slurred?
- Was there a choking or aspiration episode?
- Is diet modification currently needed?
Infusion / Treatment Session
Log each biologic infusion or plasma exchange session with treatment type, cycle position, reaction capture, and perceived symptom response.
Sample questions
- Which treatment was administered?
- What cycle week is this infusion?
- Were there any infusion reactions?
- Has there been any symptom improvement since the last session?
MG Functional Assessment
Daily MG-ADL-inspired composite check-in scoring all 8 domains — talking, chewing, swallowing, breathing, arm function, leg function, ptosis, and diplopia.
Sample questions
- How is speech today on a 0–3 scale?
- How difficult is rising from a chair?
- Is there eyelid drooping affecting vision?
- How is breathing difficulty rated today?
Respiratory Function
Monitor breathing symptoms with crisis warning indicators — including cough strength, positional breathing, and whether breathlessness is limiting speech.
Sample questions
- What is the severity of breathing difficulty?
- Is cough strength normal or impaired?
- Is the patient able to speak in full sentences?
- Is breathing worse when lying down?
Muscle Weakness
Log fatigable weakness by body region with time-of-day patterns, rest recovery, and functional impact on daily activities.
Sample questions
- Which body regions are affected?
- Does weakness improve with rest?
- What is the severity on a 1–10 scale?
- What activities were impacted?
Ready to see Myasthenia Gravis Monitoring in action?
Book a demo and we'll walk you through this study configuration live.